Abstract
Background
Post-stroke spasticity is a frequent complication of stroke. Early interventions aimed at positioning the limb in a reflex-inhibiting posture may help reduce the severity of spasticity.
Purpose
This trial aimed to evaluate the efficacy of the supinated forearm, extended fingers and elbow and an abducted and externally rotated shoulder, with the wrist in neutral position (SEA posture), in preventing the severity of upper limb spasticity in acute stroke patients with flaccid weakness.
Methods
In this prospective, single-centre, randomised, open-label controlled trial with blinded outcome assessment, 76 acute stroke patients aged 18–80 years presenting within 72 hours with flaccid upper limb weakness were enrolled. Patients were randomised 1:1 to receive either the SEA posture intervention using a splint for at least 210 minutes daily plus conventional physiotherapy (n = 38) or conventional physiotherapy alone (n = 38). The primary outcome was spasticity measured by the Modified Ashworth Scale (MAS) at three and six months. Secondary outcomes included the Modified Rankin Scale (mRS) and the Barthel Index.
Results
After six months, 66 patients completed follow-up (34 intervention, 32 control). Groups were comparable at baseline. The intervention group showed significantly lower spasticity scores at the elbow, forearm, wrist and fingers at both three and six months (p < .05). Barthel Index scores were significantly better in the intervention group, while mRS scores did not differ between the groups. No adverse effects related to splinting were noted.
Conclusion
Early application of the SEA posture reduces the severity of upper limb spasticity after acute stroke and improves functional independence.
Keywords
Introduction
Spasticity is a common sequela of upper motor neuron lesions, frequently observed in conditions such as stroke, traumatic brain injury and multiple sclerosis. 1 Following a stroke, the prevalence of spasticity has been reported to range from 19% to 92%, often emerging within the first few weeks after the insult. 2 Motor recovery typically progresses through a sequence of flaccidity, increasing tone and, eventually, selective voluntary control. However, in the absence of adequate neuroplastic recovery, aberrant reflex activity and persistent hypertonia may lead to disabling spasticity and contractures, particularly in the upper limb. 3
The typical spastic upper limb posture, characterised by flexed fingers, wrist and elbow, pronated forearm and adducted and internally rotated shoulder, is well-recognised. Over the decades, therapeutic positioning strategies have been recommended to counteract these patterns, especially within neurodevelopmental frameworks such as the Bobath concept.4–6 These reflex-inhibiting postures aim to maintain muscles in lengthened positions, thereby reducing aberrant reflex activity and promoting more normal tone and movement patterns.
While splinting and positioning techniques have been explored in various studies and systematic reviews, most have focused on chronic spasticity or heterogeneous positioning methods, including static resting splints or orthoses with variable application duration.7, 8
Given that many acute stroke patients spend significant portions of the day in passive postures, early application of therapeutic positioning during this window of heightened neuroplasticity (one to six weeks post-stroke) may offer a practical, low-cost intervention to prevent spasticity. 3 In particular, prolonged daily use of reflex-inhibiting postures such as a supinated forearm, extended elbow and fingers, abducted and externally rotated shoulder and neutral wrist may be beneficial if consistently maintained.
The present study aimed to evaluate the efficacy of a standardised supinated forearm, extended fingers and elbow and an abducted and externally rotated shoulder, with the wrist in neutral position (SEA posture), applied via splinting for at least 210 minutes daily, initiated in the acute flaccid stage, in preventing the severity of upper limb spasticity. To our knowledge, this is the first randomised controlled trial assessing this specific approach in flaccid upper limbs of acute stroke patients with clearly defined parameters and longitudinal follow-up.
Methods
This was a prospective, single-centre, open-label, randomised controlled trial. However, the outcome was blindly assessed. This study was conducted from December 2020 to December 2022 at the Department of Neurology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India. The study was approved by the Institutional Ethics Committee (2020/EC/2110). The study was prospectively registered with the Clinical Trials Registry–India (CTRI) on 1 December 2020 (CTRI No. CTRI/2020/12/029482). Informed consent was taken from the patient or a relative (if the patient could not provide consent). Confidentiality of the records was maintained. Patients presenting to the neurology department with clinical features of acute stroke were assessed for enrolment in the study. The Consolidated Standards of Reporting Trials 2010 guideline was followed.
Inclusion Criteria
All acute stroke patients of either sex between 18 and 80 years of age with flaccid upper limb monoplegia, hemiplegia or quadriplegia presenting within 72 hours to the Neurology Department of Sir Sundarlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi were included in the study.
Exclusion Criteria
Patients with monoparesis, hemiparesis or quadriparesis, large ischaemic infarct or haemorrhage needing intensive care unit, sepsis, hemodynamic instability, respiratory distress or on ventilatory support, central nervous system infection, major head trauma, planned surgical procedure (decompressive hemicraniectomy) or post-operative cases, hepatic or kidney disease, musculoskeletal complications such as fracture or limb deformity, malignancy or withdrawal of consent were excluded.
Sample Size
This study was designed as a prospective, proof-of-concept, randomised controlled trial to evaluate the feasibility and preliminary efficacy of the SEA upper limb posture in mitigating early post-stroke spasticity. At the time of study conceptualisation, no prior randomised trials had specifically assessed the preventive impact of such a posture-based intervention in the acute stroke setting. Consequently, effect size estimates to inform a priori sample size calculation were unavailable. To provide a statistically grounded basis for participant recruitment, we conducted a post hoc sample size estimation using pilot data derived from institutional physiotherapy logs and retrospective Modified Ashworth Scale (MAS) score distributions. Assuming a two-sided alpha (α) of 0.05, power (1-β) of 80% and an estimated effect size (Cohen’s d) of 0.7—corresponding to a moderate difference in MAS scores between intervention and control groups at six months—the minimum required sample size was calculated to be 26 participants per group. Anticipating an attrition rate of approximately 20%, the final target sample size was adjusted to 66 participants (33 per group). This estimation was deemed appropriate for the intended exploratory objectives.
Intervention
The enrolled patients were randomised into two groups: The intervention (SEA) arm and the control arm.
Experiment Arm
The intervention arm received the reflex-inhibiting posture, SEA posture, for 30 minutes every three hours in the supine position. The arm was positioned in a partially abducted, externally rotated position with the wrist in a neutral position and the elbow and fingers extended. A splint was used for the maintenance of the defined posture in the supine position (Figure 1).
Supination, External Rotation, Abduction (SEA) Posture Showing the Positioning of the Upper Limb with the Arm Partially Abducted and Externally Rotated (Blue Arrow), Elbow and Fingers Extended (Black Arrow) and Wrist in a Neutral Position (White Arrow), Supported by a Splint in the Supine Position.
However, the limb position in the side turned posture on the affected as well as the unaffected side was kept as feasible. Hence, a person’s upper limb was kept in the above-mentioned posture at least for 210 minutes per day. Additionally, conventional physiotherapy was continued in the control arm. A trained and dedicated physiotherapist (S.H.) explained the duration and number of sessions to the caregiver during the first seven days of the hospital stay. This limb positioning was reinforced by the physiotherapist after discharge from the hospital through structured caregiver education and home-based rehabilitation instructions.
Control Arm
Patients received conventional physiotherapy only.
Randomisation
Patients were randomised in a 1:1 manner within 24 hours of hospital admission to receive either intervention (SEA posture) or no intervention (control group). A computer-generated system performed randomisation. This was an open-label study and only the outcome assessment was blinded.
The management protocol of the stroke, as per aetiology, was same in both the groups, irrespective of randomisation. Pain-relieving medications were used according to need.
Neurological Evaluation
The patients were subjected to a detailed medical history, including onset, duration and progression of illness, modifiable and non-modifiable risk factors of stroke. Thorough cardiovascular, respiratory, abdominal and neurological examinations were done.
Investigations
This included complete hemogram, kidney, liver function tests, urine examination, fasting and post-prandial blood sugar, thyroid function test, fasting lipid profile, cranial magnetic resonance imaging with intracranial and extracranial angiography, electro and 2D echocardiography, chest X-ray, vitamin B12 and homocysteine levels. Young stroke patients were investigated for any underlying prothrombotic states.
Management
All enrolled patients were admitted to a dedicated stroke unit at our centre. The ischaemic and haemorrhagic stroke patients were managed as per standard medical care and other treatments, including anti-oedema measures and antihypertensive medications.
Outcome
The primary outcome was the assessment of spasticity at three and six months. Spasticity was assessed using the MAS in the shoulder, elbow, pronator-supinator, wrist and fingers. Secondary outcome measures were the change in Modified Rankin Score (mRS) and the Barthel Index at three and six months and splint-related complications.
Statistical Analysis
Continuous and normally distributed data were expressed as mean (standard deviation), whereas continuous but skewed data were expressed as median (interquartile range [IQR]). Categorical data were presented as numbers (percentages). Comparison of outcome measures (mRS, Ashworth spasticity score and Barthel Index) between the two groups was done by chi-square test. All calculations were performed with the Statistical Package for the Social Sciences (SPSS) 25 (SPSS Inc., Chicago, IL 60606- 6412, USA). Variables with a p value <.05 were considered significant.
Results
A total of 170 stroke patients were screened for eligibility, of which 76 patients met the inclusion criteria and were enrolled in the study. Following randomisation, 38 patients were assigned to the intervention group (SEA posture group) and 38 to the control group. Over a follow-up period of six months, 10 patients were lost to follow-up-four from the SEA group and six from the control group-resulting in a final sample size of 66 patients (34 in the SEA group and 32 in the control group) for outcome analysis (Figure 2).
Flowchart of Participant Recruitment, Randomisation and Follow-up Throughout the Study.
The median age of participants was 55 years (IQR: 50–65) and 64% (n = 42) were male, with 21 males in each group. As shown in Table 1, there was no statistically significant difference in baseline demographic, clinical, radiological or functional status between the two groups.
Comparison of Baseline Demographic Variables Between Two Groups.
The mean age was comparable (56.44 ± 10.96 years in Group 1 vs. 57.47 ± 13.14 years in Group 2, p = .73). The distribution of ischaemic versus haemorrhagic strokes was not significantly different (p = .06). Both groups had similar scores at admission for the National Institutes of Health Stroke Scale, Intracerebral Haemorrhage score, mRS, Barthel Index and Medical Research Council sum score. The duration of illness and hospital stay was also statistically similar between the groups. Baseline laboratory parameters, including haemoglobin, renal function, liver enzymes, lipid profile, homocysteine levels and glycaemic control, were comparable across both groups (p > .05 for all; Table 2).
Comparison of Laboratory Parameters Between the Two Groups.
Primary Outcome
At three months, patients in the SEA group exhibited significantly lower spasticity scores across multiple joints. Specifically, the median MAS score at the elbow was 2.5 (IQR 1–3) in the SEA group compared to 3 (2–4) in the control group (p = .014). Similarly, the scores were lower in the SEA group for the pronator-supinator muscles (2 [2–3] vs. 3 [2–4], p = .012), wrist (2 [1–3] vs. 3 [2–4], p = .008) and fingers (2 [2–3] vs. 3 [2–4], p = .007). A trend toward significance was also noted at the shoulder (p = .055), favouring the SEA posture (Table 3).
Comparison of Outcome Measures Between the Two Groups at Three Months.
These differences persisted at six months, with significantly lower MAS scores in the SEA group for the elbow (2 [1–3] vs. 3 [2–3], p = .028), pronator-supinator (2 [1–3] vs. 3 [2–4], p = .027), wrist (2 [1–3] vs. 3 [2–4], p = .007) and fingers (2 [2–3] vs. 3 [2–4], p = .010). However, no statistically significant difference was observed at the shoulder at six months (p = .537) (Table 4).
Comparison of Outcome Measures Between the Two Groups at Six Months.
Secondary Outcomes
The Barthel Index, which reflects the level of functional independence, was significantly higher in the SEA group at both three and six months. At three months, the SEA group had a median Barthel Index score of 75 (IQR 48.75–90) compared to 50 (32.5–77.5) in the control group (p = .017). This functional advantage was sustained at six months, with scores of 82.5 (70–95) in the SEA group and 65 (41.25–82.5) in the control group (p = .021). Although the mRS did not show statistically significant differences between the groups at either three months (p = .56) or six months (p = .25), a greater number of patients in the SEA group achieved lower mRS scores at both time points, suggesting a trend toward better overall functional outcomes (Tables 3 and 4). The splint was well-tolerated and no evidence of skin breakdown or adverse reactions to splint wearing was reported in the intervention arm.
Discussion
Upper limb spasticity is a frequent sequela of stroke, particularly in patients with severe initial deficits. Approximately 20%–30% of stroke survivors develop spasticity within three months, with upper limb involvement being more common and functionally disabling. 9 The underlying pathophysiology is attributed to an imbalance between excitatory and inhibitory inputs to spinal motor neurons, further exacerbated by maladaptive cortical and subcortical plasticity. This leads to hyperexcitability of the stretch reflex arc, contributing to muscle overactivity. 10 Given the progressive nature of spasticity, early intervention becomes crucial to prevent the cascade leading to fixed contractures, joint deformities and long-term functional disability.
Spastic upper limb patterns have been systematically classified into five distinct types based on characteristic postures at the shoulder, elbow, forearm and wrist. 11 This classification provides a valuable framework for tailoring interventions. The SEA posture used in the present study was designed with reference to these spasticity patterns to enhance the effectiveness of intervention in the study population. The SEA posture was implemented early in the course of illness, maintained consistently during hospitalisation and reinforced post-discharge through caregiver education and rehabilitation guidance. The study findings indicate a statistically significant benefit of SEA posture in mitigating spasticity, as reflected by lower MAS scores in the intervention group across the elbow, pronation/supination, wrist and fingers at three months post-stroke. These differences remained significant at six months across all mentioned joints, suggesting a durable therapeutic effect of the intervention.
These results align with the biomechanical rationale that early reflex-inhibiting positioning can prevent the establishment of flexor-dominant postures commonly seen in hemiparetic limbs. In a small randomized controlled trial (RCT) from the Netherlands involving subacute stroke patients with severe arm paresis, additional positioning therapy significantly reduced the progression of shoulder abduction contracture over five weeks compared to conventional care alone (−5.3-degree vs. −23-degree, p = .042). No significant differences were noted in other outcomes, including passive range of motion (PROM), spasticity, pain, motor recovery (Fugl–Meyer Assessment) or activities of daily living (ADL) independence (Barthel Index). The intervention consisted of 30-minute positioning sessions twice daily, five days a week. 12 Although the study did not demonstrate a significant change in spasticity severity, it supported the role of mechanical limb alignment in attenuating musculoskeletal complications and secondary deformities. Our study extends these observations by demonstrating not only meaningful improvements in ADL independence but also a reduction in spasticity score.
Salazar et al. conducted a systematic review and meta-analysis to assess the effectiveness of static stretching (using positioning orthoses or simple positioning) on post-stroke upper limb spasticity and mobility. The review included three studies (57 participants) for spasticity and seven studies (210 participants) for mobility. Static stretching with orthoses significantly reduced wrist-flexor spasticity compared to no therapy. However, simple positioning showed no significant benefit over conventional physiotherapy for maintaining shoulder and wrist mobility. The evidence quality was rated low to very low, highlighting the need for further randomised clinical trials. 13 Our study overcomes some of these limitations through its randomised controlled design, structured intervention and extended follow-up period. Furthermore, the absence of significant differences in hospital stay duration or the incidence of stroke-related complications suggests that the observed benefits were not confounded by other clinical variables.
A systematic review by Kerr et al. evaluated the effectiveness of stretching and splinting interventions in adults with upper extremity spasticity. The study reported low strength of evidence supporting static splinting for reducing spasticity, but moderate strength for its role in improving hand function and functional task performance. 14 In contrast, the present study demonstrated a significant reduction in spasticity across multiple upper limb joints in the intervention group at both three and six months.
Pizzi et al. conducted a pretest-post-test trial on 40 poststroke patients with upper limb spasticity, assessing the effects of a volar static reflex inhibitory splint (RIS) worn daily for 90 minutes over three months. Significant improvements were noted in wrist PROM, reduced elbow spasticity, wrist pain and spasms. RIS was well-tolerated and the study demonstrated the value of early, structured positioning in reducing spasticity. 15 Our study findings also support the benefits of early, targeted upper limb positioning in reducing the severity of spasticity.
Similarly, Kim et al. also evaluated a custom-designed hand-stretching device for managing finger flexor spasticity in chronic hemiparetic stroke patients. The device was used for 10 minutes twice daily over four weeks. In a randomised controlled trial of 15 patients, only the intervention group showed a significant reduction in MAS scores post-intervention (p < .05). 16 In a study by Basaran et al. to assess the effect of nocturnal volar or dorsal hand splinting on wrist-flexor spasticity and PROM in post-stroke patients, there were no statistically significant differences in spasticity parameters (MAS, H latency, Hmax:M max ratio) or wrist extension PROM among the dorsal splint, volar splint and control groups after the five-week period. The lack of significant effect might be due to small sample size, inclusion of chronic stroke patients, a short five-week splinting period and suboptimal hand positioning during passive movement. 17 Thibaut et al. conducted a randomised, single-blind controlled trial to evaluate the effectiveness of soft splints in managing upper limb spasticity and improving hand opening in 17 chronic patients with disorders of consciousness. The intervention involved 30-minute sessions of either soft splinting, manual stretching or no treatment. Both soft splinting and stretching significantly reduced spasticity in the finger flexors, while soft splinting alone led to improved hand opening. The soft splints were effective, well-tolerated and required no supervision. 18
Notably, the SEA posture appeared particularly effective in preventing spasticity of the distal upper limb. This can be attributed to its design, which positions the limb in a pattern that directly opposes the common flexor-pronator synergy seen in upper motor neuron lesions. By promoting supination and abduction, the SEA posture helps maintain soft tissue extensibility and joint mobility, particularly in the wrist and fingers regions most susceptible to early spasticity. This is clinically relevant, as persistent distal spasticity correlates strongly with reduced functional use of the hand and greater overall dependency in ADL.
A major strength of this study lies in the integration of the SEA posture into early stroke care protocols, initiated during hospitalisation and sustained into the post-discharge period. This continuity of intervention might have played a pivotal role in achieving long-lasting functional improvements. Unlike previous studies that employed positioning strategies in a passive or intermittent manner, such as those using static positioning or orthotic devices with limited carryover into daily care, our approach emphasised active caregiver education and patient compliance, which likely contributed to improved adherence and effectiveness.11, 15, 16
This study has several limitations. First, it did not incorporate standardised functional outcome measures such as the Fugl–Meyer Assessment or the Motor Activity Log, which are established tools for evaluating motor recovery, physical function and real-world limb use. Inclusion of these measures could have provided a more comprehensive understanding of the intervention’s functional impact. Second, the open-label design introduces the possibility of performance bias, although outcome assessments were conducted by blinded assessors to mitigate this risk. Third, as the study was started during the Corona Virus Disease (COVID-19) pandemic and due to the constraints of the lockdown, when neurophysiological laboratories were not fully operational, we limited our assessment to clinical measures and no neurophysiological correlates were assessed. Last, the study did not employ quantitative tools to monitor adherence to the SEA posture, such as wearable sensors or caregiver logs.
Conclusion
This study shows that using the SEA posture early and consistently after a stroke will lead to a reduction in the severity of upper limb spasticity, especially in the hand and wrist and a better functional independence. The approach is simple, non-invasive and cost-effective for early stroke care. Hence, SEA posture should be a part of standard rehabilitation for stroke patients. Further research across diverse healthcare settings is necessary to validate these findings and to develop improved methods for monitoring posture adherence and tailoring treatment to individual patient needs.
Footnotes
Acknowledgement
The authors gratefully acknowledge the financial support provided by Banaras Hindu University through the Institute of Eminence (IoE) Seed Grant.
Authors’ Contribution
Varun Kumar Singh: Concept and study design
Pratishtha Sengar: Data analysis, investigation
Pratishtha Sengar, Varun Kumar Singh: Writing the original draft
Ritika: Data collection
Rameshwar Nath Chaurasia, Varun Kumar Singh, Shahnawaz Ahmad: Patient management
All authors have reviewed and edited the manuscript.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Funding
The authors disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This work was supported by the Seed Grant (6031) under the IoE scheme, BHU, Varanasi, India.
Informed Consent
Written informed consent was obtained from the patient/caregivers for participating in the study.
Statement of Ethics
This study was conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The study was approved by the Institute’s ethics committee, IMS, Banaras Hindu University (BHU) (2020/EC/2110).
