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Abstract

PURPOSE:

To explore the effects of neuroprosthesis use on participation, level of community-based walking activity, safety and satisfaction in children with hemiplegic CP.

METHODS:

Eleven children (mean 9 years 11 months) with hemiplegic CP Gross Motor Function Classification System (GMFCS) Level I and II participated in a 16-week intervention using the Ness L300 neuroprosthesis. Outcome measures included satisfaction and performance with self-selected participation goals (Canadian Occupational Performance Measure (COPM)), level of community-based walking activity (Step Watch Activity Monitor (SAM)), trip and fall frequency (caregiver report) and a satisfaction questionnaire.

RESULTS:

Significant ( $p<$ 0.001) improvements in performance and satisfaction with self-selected participation goals (COPM) were demonstrated. No significant changes were noted in SAM values. A significant ( $p=$ 0.01) decrease in trips was demonstrated from baseline to post. Satisfaction with the device was high.

CONCLUSION:

Results indicate that daily neuroprosthesis use may improve performance and satisfaction with participation goals and reduce trips. No changes in community-based walking activity were noted. Further study is needed to examine response based on GMFCS levels, across geographical regions and between FES neuroprosthesis and a control group.

Keywords

Hemiplegia cerebral palsy participation activity neuroprosthesis functional electrical stimulation

1. Introduction

Cerebral palsy (CP) describes a group of permanent disorders of movement and posture that are attributed to non-progressive disturbances in the developing brain [1] with a prevalence rate in the United States of 3.1–3.6 per 1000 [2]. Children with CP are less involved in physical or skill-based community activities than their typically developing peers [3, 4] and demonstrate lower levels of daily walking activity [5, 6]. Hemiplegia accounts for 22.6–40% of all cases of CP [7, 8, 9, 10, 11], often affecting children with relatively high functional and cognitive levels [12].

The International Classification of Functioning, Disability and Health (ICF) framework provides an integrated and universal language for measuring health and disability applied across rehabilitation studies [13]. The ICF framework reflects a dynamic interaction between person and environment with a move toward participation as an important outcome of health [14]. This has resulted in a shift of clinical research focus from body structure and function (BSF) to an increased emphasis on activity and participation outcomes [15]. Outcomes used to measure intervention effectiveness should encompass the impact of what rehabilitation specialists offer at different levels across the ICF [14].

One treatment option for hemiplegia involves wearing an ankle foot orthosis (AFO) to improve ankle position and stability for walking. AFOs may limit active movement, potentially hinder motor learning, and contribute to muscle weakness in CP [16]. Older children are often unwilling to wear an AFO due to the bulk and discomfort [17]. Newer technology such as functional electrical stimulation (FES) neuroprostheses provide an alternative to AFOs for foot drop. Unlike older electrical stimulation devices, these newer devices do not have exposed cords or require repositioning of electrodes with each use [18]. Use of FES neuroprostheses have been shown to increase neuroplasticity, function and quality of life in adults with hemiplegia [19, 20, 21, 22, 23, 24, 25, 26, 27].

To date, studies of pediatric FES neuroprosthesis use have evaluated effects on BSF outcomes [13, 16, 17, 28, 29] using clinic-based measures. Specifically improvements in ankle range of motion (ROM) [28], gait kinematics [16, 17, 29], muscle size [16], muscle control [16, 28], strength [28] and reduced spasticity [28] have been reported. One study [28] assessed safety and reported a reduction in trips and falls during and after FES. Another study assessed satisfaction [29] and found 86% of subjects were so satisfied they chose to continue to use the device.

Clinic-based measures examine a child’s capability (what he can do) in a controlled environment, in contrast to actual performance in an everyday more natural environment [30]. Studies show that children with CP demonstrate differences in performance across settings [31, 32]. Using the Gross Motor Function Measure (GMFM) and parent questionnaires to describe motor performance in 307 children with CP, Tieman [31] found subject’s mobility methods differed across home, school and community settings. Holsbeeke [32] found low correlations between clinic-based measures (GMFM) and real world motor performance (Pediatric Evaluation of Disability Inventory) in 85 young children with CP illustrating the role that environment plays in motor performance. Based on current literature, a gap exists regarding the effects of a neuroprosthesis on participation of children with CP in their natural environment and level of community-based walking activity. The use of new technology, such as a neuroprosthesis, not only requires understanding the changes it imposes on an individual’s capacity in a structured clinical environment; practitioners also need to understand how these interventions affect a child’s community-based activity and participation in daily life and meaningful activities [33].

The purpose of this pilot study was to explore the effects of FES neuroprosthesis use on participation and community-based activity level in children with hemiplegic CP. We further sought to augment existing literature regarding user safety and satisfaction associated with the use of a neuroprosthesis.

2. Methods

This study was approved by the Institutional Review Board. Written parental consent and participant assent were obtained prior to participation, in accordance with institutional policy.

2.1 Design

This study was part of a larger two-factor repeated measures pilot study [34] of FES neuroprosthesis intervention that assessed clinic-based measures of gait and function at baseline and post-intervention with the stimulation turned off and repeated with the stimulation turned on. Also obtained in the larger study, and the focus of this report, were self-selected individualized participation goals, community-based walking activity level, safety data on trip and fall frequency and user satisfaction.

Table 1
Inclusion and exclusion criteria

Inclusion	Exclusion
$\bullet$ 6–17 years $\bullet$ Hemiplegic CP $\bullet$ GMFCS I and II $\bullet$ Tolerance to neuroprosthesis stimulation at screening visit $\bullet$ Willingness to travel to and from study visits $\bullet$ Ability to follow instructions and cooperate with protocol	$\bullet$ Dorsiflexion PROM $<$ 0 degrees in supine with knee extended $\bullet$ Orthopedic procedure to affected limb in last year $\bullet$ Any metal implants containing electrical circuitry $\bullet$ Co-occurring conditions that might limit ability to participate such as uncontrolled seizures $\bullet$ Botox within past 3 months

2.2 Study participants

Given the exploratory nature of this study, sample size estimation was not performed for these outcomes. Participants included the same 11 individuals with hemiplegic CP (mean age 9 years 11 months) enrolled in the larger study evaluating the use of FES neuroprosthesis on clinic-based measures of gait and function reported previously [34] Inclusion and exclusion criteria are presented in Table 1. Upon enrollment, demographic information, GMFCS classification level, brace wear, and range of motion for the affected ankle were obtained. The majority of participants ( $n=$ 8) were male, seven had right sided hemiplegia, nine were classified as GMFCS Level I and seven were daytime brace wearers at the time of enrollment. With the exception of three participants, all testing was completed at the same time of day for baseline and post assessments by the PI.

2.3 Measures

2.3.1 Canadian Occupational Performance Measure

Performance and satisfaction with individualized participation goals were assessed at baseline and post with the Canadian Occupational Performance Measure (COPM) [35], a standardized client-centered semi-structured interview designed to detect change in a client’s self-perception of occupational performance over time [36]. At enrollment, the caregiver and/or child (dependent on willingness to contribute) identified up to four goals where they anticipated positive outcomes following neuroprosthesis use. The performance and satisfaction scores for each goal are summed and averaged to result in a score up to 10. The same caregiver identified and rated the goals at the initial interview and post assessment. Caregivers and participants did not view previous results. Overall scores generated from the COPM were utilized for analysis.

2.3.2 Step Watch Activity Monitor

Community-based walking activity level was measured using the Step Watch Activity Monitor (SAM) (Orthocare Innovations Oklahoma City, OK), a light- weight motion sensor device worn around the ankle that records step counts from a single leg [37]. It is a valid and reliable instrument to measure physical activity in CP [5, 38]. The SAM was fitted to the lateral side of the uninvolved ankle and calibrated to the child’s height and walking pattern. Previous studies report on SAM data capture ranging from 3 [37] to 7 days [5]. The child was instructed to wear the SAM for three typical days in the week (consecutive days not required) prior to beginning the protocol and for three days during the last week of intervention during all of their waking hours except when bathing or swimming. Step activity data were analyzed to obtain mean values of total daily step activity, percentage of daily time active, percentage of daily active time spent in low intensity (1–15 steps/min), moderate intensity (16–40 steps/min), and high intensity ( $>$ 40 steps/min) [6]. Average total steps/day, percent time active, ratio of medium to low activity, and percentage of time at high activity were compared.

2.3.3 Falls and trips

A fall and trip questionnaire was completed as a measure of safety. At baseline and post, the parent with child input completed a short questionnaire regarding trips and falls experienced in the previous month. In addition, parents were asked to report any falls or trips that occurred during the entire study period that included any injury requiring medical attention.

2.3.4 Caregiver and child satisfaction

A satisfaction questionnaire [27, 39] was completed by the caregiver and separately by the child ( $\geqslant$ 11 years old as determined by institutional IRB) at the post assessment. The satisfaction questionnaire was similar to that previously used in adult studies of FES neuroprosthesis, but has not be validated for the pediatric population. Responses to questions were categorical in nature. In addition, they were asked if they wished to continue to use the neuroprosthesis at the end of the study. This 13 item survey includes a range of scores from 0–27; a higher number indicating greater satisfaction with the device.

2.4 Intervention

The Ness L300 Foot Drop System manufactured by Bioness Inc. (Valencia CA, USA) was utilized for this study. The system consists of three components that communicate via radio frequency signals: 1) cuff with integrated stimulation unit and electrodes, 2) a gait sensor placed in the shoe that detects the force under the foot using a force sensitive resistor and 3) a control unit. Algorithms analyze the gait sensor data to detect heel strike and toe off in real time, and use this information to control stimulation of the ankle dorsiflexors. The protocol described previously [34] consisted of a 4 week accommodation phase followed by 12 weeks of recommended daily use of 6 hours day. Details of the protocol included screening and enrollment, baseline assessment within 2 weeks of screening, a four week accommodation period consisting of seven PT visits for the purpose of learning to use the device and gradually increasing wear time, 12 weeks of daily use including monthly well check PT visits, and a post assessment. The manufacturer’s protocol for home use was followed in setting stimulation parameters, providing maintenance and skin care guidelines, performing the initial fitting, and providing instruction for the accommodation period [40]. No additional PT outside of the described protocol was provided during the study protocol. Families were instructed to keep a diary noting hours of use each day, skin integrity and other concerns. The data reported here represent satisfaction and performance with participation goals, community-based walking activity level, and caregiver report on safety and satisfaction with the neuroprosthesis device.

2.5 Data analysis

Study data were collected and managed using Research Electronic Data Capture (REDCap) [41]. All analyses were completed with SAS 9.3 with an alpha level of $p=$ 0.05. Data were examined for normality via Shapiro-Wilk and Kolmogorov-Smirnov values. Unless otherwise specified all data were distributed normally. A paired t test or the non-parametric equivalent was computed for COPM scores, SAM values, and reported falls and trips. Effect sizes were calculated. Descriptive information is provided for responses to the satisfaction questionnaire.

3. Results

Results were completed for data on 11 participants (mean age 9 years, 11 months). Due to an L300 firmware error that was not detected prior to enrollment, data from the neuroprosthesis device were not available to accurately calculate wear time or number of steps taken per day while wearing the device. Based on sufficient completion of the diary by eight caregivers, four individuals averaged six or more hours of wear per day and four averaged 3–6 hours per day. Three participants documented greater than 60 days of wear, four between 30–60 days of wear, and one less than 30 days of wear during the 12 weeks.

COPM performance and satisfaction scores were distributed normally and assessed with the paired t test. Significant improvements were noted in COPM performance scores with a mean difference of 2.44 points (95% CI $=$ 1.33 to 3.55, $p=$ 0.0006; effect size $=$ 1.87) and satisfaction scores with a mean difference of 3.24 points (95% CI $=$ 1.74 to 4.74, $p=$ 0.0007; effect size $=$ 2.04).

Figure 1.

Perfomance and Satisfaction with Canadian Occupational Performance Measure (COPM) goals at Baseline and Post FES neuroprosthesis intervention. ${}^{*}$ Statistically significant evaluated with paired t test.

Figure 2.

Reported falls and trips at Baseline and Post. ${}^{*}$ Statistically significant analyzed with Wilcoxon signed rank test.

Community-based walking activity data downloaded from the SAM were available for 10 participants. SAM scores were distributed normally and assessed with the paired t test. No significant differences were found in average daily total step count ( $p=$ 0.91; effect size $=$ 0.05) percent time active ( $p=$ 0.82; effect size $=-$ 0.10), ratio of medium to low activity ( $p=$ 0.29; effect size $=$ 0.54) and percentage of time at high activity ( $p=$ 0.50; effect size $=$ 0.25). Values are reported in Table 2.

Table 2

Baseline and post values for step watch values ( $n=$ 10)

Step watch values	Baseline		Post		Mean difference
Average daily total steps	4678	(1722)	4600	(1648)	77.7	(2122)
Percent time active	22.63	(5.06)	22.14	(5.37)	$-$ 0.50	(6.6)
Ratio of medium to low activity	0.51	(0.25)	0.41	(0.12)	$-$ 0.10	(0.28)
Percentage of time at high activity	2.00	(1.3)	1.7	(1.2)	$-$ 0.31	(1.41)

Results provided as Mean (SD) $n=$ 10; Steps are for single leg only.

Table 3

Results from satisfaction questionnaire

Question		Caregiver responses			Child responses
		( $n=$ 11) N (%)			( $n=$ 3) N (%)
1.	How do you feel about yourself/your child	10	(91%)	Enthusiastic	2	(67)
	continuing with use of the L300 System?	1	(9%)	Indifferent	1	(33)
		0		Unenthusiastic	0
2.	How would you rate the L300 System against other	9	(82)	More useful	2	(67)
	aids to assist your/your child’s gait and function?	2	(18)	As useful	1	(33)
		0		Less useful	0
3.	How much help did you/your child need in working	6	(55)	I rarely needed assistance	1	(33)
	the L300 System?	3	(27)	I occasionally needed assistance	1	(33)
		2	(18)	I needed assistance almost each time	1	(33)
4.	How satisfied are you with the dimensions (size,	7	(67)	Satisfied	3	(100)
	height, length, width) of the L300 System?	4	(36)	More or less satisfied	0
		0		Not satisfied	0
5.	How satisfied are you child with the ease in putting	9	(82)	Satisfied	1	(33)
	on and taking off the L300 System?	2	(18)	More or less satisfied	2	(67)
		0		Not satisfied	0
6.	How would you describe using the L300 System	4	(36)	Very convenient	1	(33)
	during the day?	6	(55)	Convenient	2	(67)
		1	(9)	Inconvenient	0
7.	How would you describe your/your child’s walking	7	(64)	Significantly better	1	(33)
	ability while using the L300 System?	3	(27)	Better	2	(67)
		1	(9)	Same	0
		0		Worse	0
8.	While using the L300 System, has there been a	5	(45)	Can perform more activities	0
	change in your/your child’s ability to perform daily	6	(55)	Can perform the same	3	(100)
	tasks or activities?	0		Can perform fewer activities	0
9.	How would you rate your/your child’s confidence	9	(82)	More confident with the L300	3	(100)
	in walking with the L300 System versus without it?	2	(18)	No difference	0
		0		Less confident with the L300	0
10.	Do/does you/your child feel greater confidence in	9	(82)	Yes	2	(67)
	walking on inclines and/or uneven ground while using	2	(18)	No	1	(33)
	the L300 System?
11.	Do you find the use of the L300 System safe?	11	(100)	Yes	3	(100)
		0		No	0
12.	Would you recommend a person with your/your	11	(100)	Yes	3	(100)
	child’s condition use the L300 System?	0		No	0
13.	Do you wish to continue to use the L300 system?	11	(100)	Yes	3	(100)
		0		No	0

The number of falls and trips were not distributed normally and were evaluated with the Wilcoxon signed rank test. There was no significant difference in falls reported at baseline and post with a median difference of $-$ 1 (interquartile range $=-$ 1 to 1; $p=$ 0.67; effect size $=-$ 0.28). Significantly fewer trips were reported at post with a median difference of $-$ 3 (interquartile range $=$ 1 to 5; $p=$ 0.01; effect size $=-$ 1.42). Three individuals reported a fall or trip while wearing the device during the 16 week intervention period. None of these required medical attention.

Eleven caregivers and three children completed the satisfaction questionnaire. Average score for caregiver report ( $n=$ 11) was 23.3 (s.d. 2.7). For child self-report ( $n=$ 3) the average score was 21.7 (s.d. 3.8). Frequencies and proportions for categorical responses to each question are presented in Table 3. All of the respondents (11 caregivers, 3 children) answered that they wished to continue to use the L300 device. All of the caregivers ( $n=$ 11) and 2 of 3 children rated the neuroprosthesis as more useful than other gait aids. Six of the 11 caregivers and all of the children stated that their ability to perform daily tasks or activities was the same since using the device while no one reported that they performed fewer activities.

4. Discussion

This is the first study to evaluate the effects of FES neuroprosthesis use on participation and level of community-based walking activity in children with hemiplegic CP. This study demonstrated that daily use of an FES neuroprosthesis may improve satisfaction and performance with self-selected participation goals and decrease the frequency of trips. Further, satisfaction was high with all that completed the satisfaction questionnaire (11 parents, 3 children) wishing to continue to use the device at the end of the study.

This study did not demonstrate improvements in level of community-based walking activity as measured by the SAM device which is consistent with other intervention studies in children with CP [42, 43]. In a pre-post intervention study of children with CP (ages 4–12 years), Christy [42] assessed the effect of a 3 week intensive therapy program on walking activity. In a randomized crossover trial of children with CP (ages 3–6 years) Bjornson compared walking activity in an AFO to non AFO condition [43]. Both studies utilized five days of SAM data for analysis. While the current activity dataset is more limited due to device availability (three days of data monitoring instead of five), the baseline average daily step count in our sample (4678, SD 1772) is similar to Bjornson [43] (4660, SD 1421) but greater than Christy [42] (2575, SD 1766). While both prior studies [42, 43] included children GMFCS Levels I-III, Christy [42] included a majority of children at GMFCS Level III who walk with an assistive device which likely explains their lower average number of daily steps. In an earlier study by Bjornson [5], step activity in 81 youth with CP GMFCS Levels I-III (ages 10–13) was compared to that of typical children. The average daily step count in the current study was also similar to the 81 youth with CP in that study (4222 SD 2319). A study by Stevens [6] compared 4 days of step activity data in a younger group (4 $<$ 10 years) of children with CP GMFCS Levels I and II to older children (10–18 years) also levels GMFCS I and II. The children in the current study are most similar to Steven’s older sample in terms of age, GMFCS level and average daily step count (3171, SD 1927).

Children in the current study spent less time active (22.6%) than the groups studied by Bjornson [43] (AFO on (49%) and AFO off (46%)), Bjornson [5] (40.2%) and Christy [42] (34.7%), but similar time active to Stevens [6] older group (19.3%). Some of these difference may be due to age as Bjornson [43] included ages 3–6 years. However age cannot explain the differences entirely as the children studied by Christy [42] were 4–12 years, and Bjornson [5] included children 10–13 years.

In assessing the ratio of medium level to low level activity, children in the present study demonstrated a ratio of 0.51. This is greater than findings of both Bjornson [5] (0.33), and Stevens [6] older group (0.27), suggesting that the children in our study spent relatively more time in medium level activity. Last, the children in our study spent less time in high activity (2%) than children in both the Bjornson [5] (5.6 %) and Stevens [6] (4.5 %) studies. These differences in % time active, ratio of medium to low activity and % time at high activity may be due to geographical variations in children’s physical activity. Children in the current study are from Ohio, while Bjornson’s studies [5, 43] included children from Washington, Christy [42] from Alabama, and Stevens [6] from Tennessee. We are not aware of any studies that compare physical activity levels in children with CP across regions in the US. However geographic differences in children’s activity level have been reported in a nationally representative sample of typical children [44]. Specifically Sisson [44] reported more children in Washington participate in greater than or equal to 3 days a week of physical activity compared to children in Ohio or Tennessee. Further information regarding physical activity levels for children with CP across regions of the US would be useful.

Results from this study are in agreement with other studies reporting the COPM as responsive to meaningful changes due to therapy interventions [36, 42, 45]. In the current study, the mean improvement in performance and satisfaction was clinically meaningful $\geqslant$ 2 [46]. The goals identified by the client and caregiver for this study reflected individual goals of participation (e.g. playing hopscotch better, improved butterfly kick resulting in fewer disqualifications during swim meets, and more even weight distribution on legs when playing baseball).

Similar to the adult literature using this satisfaction questionnaire [27, 39], a majority of our participants were satisfied and all wanted to continue to use the FES neuroprosthesis after the intervention period. When considering interventions, therapists should choose options that reflect the motivations and interests of the individual [47]. The oldest participant in our study (16 years) preferred the neuroprosthesis to her AFO because she could easily turn it off and drive without removing the device. She was unable to drive while wearing her AFO. Wingstrand [48] reports AFO wear decreases with age which is consistent with the clinical experience of these investigators. It has been our experience that some children, especially adolescents, may be more motivated to wear a neuroprosthesis over an AFO due to its novelty and perceived technological benefits.

Reducing falls and trips is a possible benefit of FES neuroprosthesis intervention [16]. Similar to Pool [28], our study reports a decrease in the number of trips but unlike Pool, we did not report a decrease in falls. While the current study relied on recall of the participant and caregiver Pool used a five point ordinal scale ranging from “I never fall over” to “I fall over every day”. This scale may have improved the ability to detect change in reported falls and trips. Prospective data collection on falls and trips prior to intervention should be used in future studies to minimize recall bias.

Limitations of this study include the lack of repeated baseline measures, use of a small sample of convenience, the absence of a comparison group and the potential for intervention bias as the caregivers may have anticipated improvement in trips/falls compared to their recollection of prior trips or falls. Additional weaknesses were in reliance on the caregiver’s diary of device use, and limited activity monitoring due to the reduced availability of SAM devices. Future studies may benefit from improved body sensor technology to track neuroprosthesis wear time rather than relying on caregiver diaries of device wear.

5. Conclusion

The purpose of this pilot study was to investigate the effects of FES neuroprosthesis on performance and satisfaction with participation goals, level of community-based walking activity and to monitor safety and satisfaction with its use in children with hemiplegia. Findings suggest that use of an FES neuroprosthesis resulted in positive effects on self-selected participation goals and self-reported trips. Further, satisfaction was high when using the device with a high level of support that included therapy visits and communication with therapists trained in using the device. To our knowledge this is the first study to measure participation and community-based walking activity after neuroprosthesis use. Future research should examine the effects of FES neuroprosthesis on participation and community-based walking activity in a larger sample of individuals with hemiplegic CP with varying baseline function, across geographical regions and compare FES neuroprosthesis to AFO. Validated measures of satisfaction would be important to identify factors contributing to long term use of the device.

Footnotes

Acknowledgments

This study was approved by the primary investigator’s Institutional Review Board #2012-4682. This study was funded by a grant from the Pedal with Pete Foundation. We gratefully acknowledge the children and parents who participated, and Bioness Inc. for donating the NESSL300 units for use in this study.

Conflict of interest

The authors report no conflicts of interest.

References

Bax

, Goldstein

, Rosenbaum

, Leviton

, Paneth

, Dan

, Jacobsson

, Damiano

. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol 2005; 47(8): 571-6.

Christensen

, Van Naarden Braun

, Doernberg

, Maenner

, Arneson

, Durkin

, Benedict

, Kirby

, Wingate

, Fitzgerald

, Yeargin-Allsopp

. Prevalence of cerebral palsy, co-occurring autism spectrum disorders, and motor functioning – Autism and Developmental Disabilities Monitoring Network, USA, 2008. Dev Med Child Neurol 2014; 56(1): 59-65.

Majnemer

, Shevell

, Law

, Birnbaum

, Chilingaryan

, Rosenbaum

, Poulin

. Participation and enjoyment of leisure activities in school-aged children with cerebral palsy. Dev Med Child Neurol 2008; 50(10): 751-758.

Shikako-Thomas

, Majnemer

, Law

, Lach

. Determinants of participation in leisure activities in children and youth with cerebral palsy: systematic review. Phys Occup Ther Pediatr 2008; 28(2): 155-69.

Bjornson

, Belza

, Kartin

, Logsdon

, McLaughlin

. Ambulatory physical activity performance in youth with cerebral palsy and youth who are developing typically. Phys The 2007; 87(3): 248-57.

Stevens

, Holbrook

, Fuller

, Morgan

. Influence of age on step activity patterns in children with cerebral palsy and typically developing children. Archives of Physical Medicine and Rehabilitation 2010; 91(12): 1891-1896.

Yeargin-Allsopp

, Van Naarden Braun

, Doernberg

, Benedict

, Kirby

, Durkin

. Prevalence of cerebral palsy in 8-year-old children in three areas of the United States in 2002: a multisite collaboration. Pediatrics 2008; 121(3): 547-54.

Rice

, Russo

, Halbert

, Van Essen

, Haan

. Motor function in 5-year-old children with cerebral palsy in the South Australian population. Dev Med Child Neurol 2009; 51(7): 551-6.

Howard

, Soo

, Graham

, Boyd

, Reid

, Lanigan

, Wolfe

, Reddihough

. Cerebral palsy in Victoria: motor types, topography and gross motor function. J Paediatr Child Health 2005; 41(9-10): 479-83.

10.

Himmelmann

, Beckung

, Hagberg

, Uvebrant

. Gross and fine motor function and accompanying impairments in cerebral palsy. Dev Med Child Neurol 2006; 48(6): 417-23.

11.

Nordmark

, Hagglund

, Lagergren

. Cerebral palsy in southern Sweden II. Gross motor function and disabilities. Acta Paediatr 2001; 90(11): 1277-82.

12.

Riad

, Haglund-Akerlind

, Miller

. Classification of spastic hemiplegic cerebral palsy in children. Journal of Pediatric Orthopedics 2007; 27(7): 758-64.

13.

Jette

. Toward a common language for function, disability, and health. Phys Ther 2006; 86(5): 726-734.

14.

Rosenbaum

, Stewart

. The World Health Organization International Classification of Functioning, Disability, and Health: a model to guide clinical thinking, practice and research in the field of cerebral palsy. Semin Pediatr Neurol 2004; 11(1): 5-10.

15.

Bjornson

, Zhou

, Stevenson

, Christakis

. Relation of Stride Activity and Participation in Mobility-Based Life Habits Among Children With Cerebral Palsy. Arch Phys Med Rehabil 2014; 95(2): 360-368.

16.

Damiano

, Prosser

, Curatalo

, Alter

. Muscle Plasticity and Ankle Control After Repetitive Use of a Functional Electrical Stimulation Device for Foot Drop in Cerebral Palsy. Neurorehabil Neural Repair 2013; 27(3): 200-7.

17.

Danino

, Khamis

, Hemo

, Batt

, Snir

, Wientroub

, Hayek

. The efficacy of neuroprosthesis in young hemiplegic patients, measured by three different gait indices: early results. J Child Orthop 2013; 7(6): 537-42.

18.

Van der Linden

, Hazlewood

, Hillman

, Robb

. Functional electrical stimulation to the dorsiflexors and quadriceps in children with cerebral palsy. Pediatr Phys Ther 2008; 20(1): 23-9.

19.

Robbins

, Houghton

, Woodbury

, Brown

. The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil 2006; 87(6): 853-9.

20.

Kottink

, Oostendorp

, Buurke

, Nene

, Hermens

, IJzerman

. The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review. Int J Artif Organs 2004; 28(6): 577-86.

21.

Everaert

, Thompson

, Chong

, Stein

. Does functional electrical stimulation for foot drop strengthen corticospinal connections? Neurorehabil Neural Repair 2010; 24(2): 168-77.

22.

Ring

, Treger

, Gruendlinger

, Hausdorff

. Neuroprosthesis for footdrop compared with an ankle-foot orthosis: effects on postural control during walking. J Stroke & Cerebrovasc Dis 2009; 18(1): 41-7.

23.

Laufer

, Ring

, Sprecher

, Hausdorff

. Gait in individuals with chronic hemiparesis: one-year follow-up of the effects of a neuroprosthesis that ameliorates foot drop. J Neurol Phys Ther 2009; 33(2): 104-10.

24.

Dunning

, Black

, Harrison

, McBride

, Israel

. Neuroprosthesis peroneal functional electrical stimulation in the acute inpatient rehabilitation setting: a case series. Phys Ther 2009; 89(5): 499-506.

25.

Israel

, Kotowski

, Talbott

, Fisher

, Dunning

. The therapeutic effect of outpatient use of a peroneal nerve functional electrical stimulation neuroprosthesis in people with stroke: a case series. Top Stroke Rehabil 2011; 18(6): 738-45.

26.

van Swigchem

, Weerdesteyn

, van Duijnhoven

, den Boer

, Beems

, Geurts

. Near-normal gait pattern with peroneal electrical stimulation as a neuroprosthesis in the chronic phase of stroke: a case report. Arch Phys Med Rehabil 2011; 92(2): 320-4.

27.

Kluding

, Dunning

, O’Dell

, Wu

, Ginosian

, Feld

, McBride

. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke 2013; 44(6): 1660-9.

28.

Pool

, Blackmore

, Bear

, Valentine

. Effects of short-term daily community walk aide use on children with unilateral spastic cerebral palsy. Pediatr Phys Ther 2014; 26(3): 308-17.

29.

Prosser

, Curatalo

, Alter

, Damiano

. Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. Dev Med Child Neurol 2012; 54(11): 1044-9.

30.

Young

, Williams

, Yoshida

, Bombardier

, Wright

. The context of measuring disability: does it matter whether capability or performance is measured? Journal of clinical epidemiology 1996; 49(10): 1097-1101.

31.

Tieman

, Palisano

, Gracely

, Rosenbaum

. Gross motor capability and performance of mobility in children with cerebral palsy: a comparison across home, school, and outdoors/community settings. Phys Ther 2004; 84(5): 419-29.

32.

Holsbeeke

, Ketelaar

, Schoemaker

, Gorter

. Capacity, capability, and performance: different constructs or three of a kind? Archives of physical medicine and rehabilitation 2009; 90(5): 849-855.

33.

Goldstein

, Cohn

, Coster

. Enhancing participation for children with disabilities: application of the ICF enablement framework to pediatric physical therapist practice. Pediatr Phys Ther 2004; 16(2): 114-20.

34.

Bailes

, Caldwell

, Clay

, Tremper

, Dunning

, Long

. An exploratory study of functional outcomes and gait after neuroprosthesis use in children with hemiplegic cerebral palsy. Disabil Rehabil 2016; http://dx.doi.org/10.1080/09638288.2016.1225827.

35.

Law

, Baptiste

, McColl

, Opzoomer

, Polatajko

, Pollock

. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther 1990; 57(2): 82-87.

36.

Carswell

, McColl

, Baptiste

, Law

, Polatajko

, Pollock

. The Canadian Occupational Performance Measure: a research and clinical literature review. Canadian Journal of Occupational Therapy 2004; 71(4): 210-222.

37.

McDonald

, Widman

, Walsh

, Abresch

. Use of step activity monitoring for continuous physical activity assessment in boys with Duchenne muscular dystrophy. Archives of physical medicine and rehabilitation 2005; 86(4): 802-808.

38.

O’Neil

, Fragala-Pinkham

, Lennon

, George

, Forman

, Trost

. Reliability and Validity of Objective Measures of Physical Activity in Youth With Cerebral Palsy Who Are Ambulatory. Phys Ther 2016; 96(1): 37-45.

39.

Hausdorff

, Ring

. Effects of a new radio frequency-controlled neuroprosthesis on gait symmetry and rhythmicity in patients with chronic hemiparesis. Am J Phys Med Rehabil 2008; 87(1): 4-13.

40.

Bioness

. The NESS L300 Foot Drop System Training Manual Valencia, CA: Bioness Inc. ; 2012.

41.

Harris

, Taylor

, Thielke

, Payne

, Gonzalez

, Conde

. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42(2): 377-81.

42.

Christy

, Chapman

, Murphy

. The effect of intense physical therapy for children with cerebral palsy. J Pediatr Rehabil Med 2012; 5(3): 159-170.

43.

Bjornson

, Zhou

, Fatone

, Orendurff

, Stevenson

, Rashid

. The Effect of Ankle-Foot Orthoses on Community-Based Walking in Cerebral Palsy: A Clinical Pilot Study. Pediatric Physical Therapy 2016; 28(2): 179-186.

44.

Sisson

, Broyles

, Brittain

, Short

. Obesogenic behaviors in US school children across geographic regions from 2003–2007. Open Journal of Preventive Medicine 2011; 1(2): 25.

45.

Sakzewski

, Boyd

, Ziviani

. Clinimetric properties of participation measures for 5-to 13-year-old children with cerebral palsy: a systematic review. Dev Med Child Neurol 2007; 49(3): 232-240.

46.

Law

, Baptiste

, Carswell

, McColl

, Polatajko

, Pollock

. Canadian Occupational Performance Measure (2nd ed). Ottawa: CAOT Publications ACE; 1998.

47.

Novak

, McIntyre

, Morgan

, Campbell

, Dark

, Morton

, Stumbles

, Wilson

, Goldsmith

. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol 2013; 55(10): 885-910.

48.

Wingstrand

, Hagglund

, Rodby-Bousquet

. Ankle-foot orthoses in children with cerebral palsy: a cross sectional population based study of 2200 children. BMC Musculoskelet Disord 2014; 15(1): 327.

Participation and community-based walking activity after neuroprosthesis use in children with hemiplegic cerebral palsy: A pilot study 1

Abstract

PURPOSE:

METHODS:

RESULTS:

CONCLUSION:

Keywords

1. Introduction

2. Methods

2.1 Design

Table 1 Inclusion and exclusion criteria

2.3 Measures

2.3.1 Canadian Occupational Performance Measure

2.3.2 Step Watch Activity Monitor

2.3.3 Falls and trips

2.3.4 Caregiver and child satisfaction

2.4 Intervention

2.5 Data analysis

3. Results

5. Conclusion

Footnotes

Acknowledgments

Conflict of interest

References

Table 1
Inclusion and exclusion criteria