Date Presented 04/05/19
Primary Author and Speaker: Turki Aljuhani
Additional Authors and Speakers: Amanda Vatinno
Contributing Authors: Alison Fluharty, Catilyn Taylor, Eli Schuster, V. Ramakrishnan, Patty Coker-Bolt, Na Jin Seo
PURPOSE: Children with cerebral palsy (CP) present with sensorimotor upper extremity deficits, which can greatly diminish participation in functional activities (Van Zelst, Miller, Russo, Murchland, & Crotty, 2006). Historically, treatment of children with CP has focused on intensive motor-based therapies. One of the most common interventions is pediatric constraint induced movement therapy (P-CIMT), an evidence-based therapy treatment that is proven to increase upper extremity function. P-CIMT can be supplemented via neuromodulation, thus enhancing upper extremity recovery (Manning et al., 2016). TheraBracelet is a novel neuromodulation method that delivers subthreshold vibration to the affected wrist to increase brain activity (Seo et al, 2015). Studies have shown that TheraBracelet improved motor outcomes in adult survivors of stroke without adverse events (Seo et al, In Press). Therefore, we conducted this pilot study to determine the feasibility, safety, and preliminary efficacy of TheraBracelet when used in conjunction with P-CIMT.
DESIGN: Thirteen children with CP in ages three to nine participated in a pilot double-blinded stratified randomized controlled trial. Children with significant developmental delay that precluded following instructions and/or the inability to ambulate were excluded. To be included, the children must have demonstrated the ability to use the affected extremity as a gross assist during play and self-care activities. Subjects were stratified based on the Manual Ability Classification System, ranging from mild to severe upper extremity impairment, and randomized to either a treatment or control group.
METHOD: TheraBracelet was worn on the affected wrist for the duration of the P-CIMT. The treatment group received vibratory stimulation during P-CIMT, while the control group wore the same device, but received no vibration. All subjects participated in P-CIMT six hours/day for five consecutive days (30 hours). Device wear time, the pain scale, and adverse events were taken each day of treatment. The Box and Block Test (BBT) was administered at baseline and upon completion of the five-day intervention.
RESULTS: Device wear time was not significantly different between the two groups. On average, the device was worn 94% of the therapy time. Additionally, TheraBracelet did not interfere with completion of therapy tasks. Transient skin redness from the wrist strap was noted for one to two subjects in both groups. Change in pain level was not significantly different between the two groups. No other adverse events were reported. The mean increase in BBT was greater for the treatment group than the control group. However, no statistical significance was found.
CONCLUSION: Using TheraBracelet during 30-hour P-CIMT was feasible and safe, thus demonstrating that TheraBracelet may be used during P-CIMT. Given that this study was a pilot study with a very small sample size, the study was not powered to statistically detect treatment effects. A larger clinical trial may be conducted in the future to determine the clinical efficacy and optimum dosage of TheraBracelet as a therapy adjunct for children with cerebral palsy.
IMPACT STATEMENT: TheraBracelet is safe and feasible to use during P-CIMT in children with CP, thus making it a viable treatment option for patients, parents, and clinicians. Occupational therapy practitioners may consider using TheraBracelet-type stimulation as a potential adjunct to therapy.
References
Van Zelst, B. R., Miller, M. D., Russo, R., Murchland, S., & Crotty, M. (2006). Activities of daily living in children with hemiplegic cerebral palsy: a cross-sectional evaluation using the Assessment of Motor and Process Skills. Dev Med Child Neurol, 48(9), 723-727. doi:10.1017/s0012162206001551
Manning, K. Y., Menon, R. S., Gorter, J. W., Mesterman, R., Campbell, C., Switzer, L., & Fehlings, D. (2016). Neuroplastic Sensorimotor Resting State Network Reorganization in Children With Hemiplegic Cerebral Palsy Treated With Constraint-Induced Movement Therapy. J Child Neurol, 31(2), 220-226. doi:10.1177/0883073815588995
Seo, N. J., Lakshminarayanan, K., Bonilha, L., Lauer, A. W., & Schmit, B. D. (2015). Effect of imperceptible vibratory noise applied to wrist skin on fingertip touch evoked potentials - an EEG study. Physiol Rep, 3(11). doi:10.14814/phy2.12624
Seo, N. J., Woodbury, M., Bonilha, L., Ramakrishnan, V., Kautz, S., Downey, R., . . . Vatinno, A. A. (in press). TheraBracelet stimulation during task-practice therapy to improve post-stroke upper extremity function - a pilot randomized controlled study. Physical Therapy.
