Static Versus Dynamic Wrist-Hand Splints to Reduce Wrist Spasticity in Subacute Hemiplegic Stroke Patients: A Randomized Control Trial
Phase: NA
Conditions: Stroke, Spasticity, Hemiplegia, Post Stroke Recovery
Sponsor: University of Lahore

STUDY PROTOCOL 
Protocol Version: 1.0 
Protocol Date: 15 June,2025 
Ethics Approval: 
Approved by IREB, University of Lahore 
Approval No: UOL/IREB/25/09/0030 
Approval Date: June 30, 2025 
Title: Static versus Dynamic Wrist-Hand Splints for Wrist Spasticity in subacute Stroke 
Patients: A Randomized Clinical Trial 
Introduction 
Stroke, or cerebrovascular accident, occurs when blood supply to part of the brain is blocked 
or a cerebral vessel ruptures, resulting in loss of oxygen and essential nutrients. This often 
leads to paralysis, weakness, impaired coordination and balance, limited mobility, or even 
death (1–3). Neurological damage disrupts motor control pathways, commonly manifesting as 
muscle weakness. Following initial injury, the brain undergoes spontaneous recovery through 
neural plasticity and reorganization (4–6). Stroke is a leading cause of disability globally, with 
24.9 million people living with stroke and 11.6 million new cases reported annually in 
Western Europe (7,8).  
Stroke is classified into ischemic (≈80%) and hemorrhagic types (9). Ischemic stroke results 
from cerebral artery obstruction causing neuronal apoptosis and necrosis in motor regions, 
while hemorrhagic stroke involves vessel rupture, increased intracranial pressure, and 
secondary neuronal damage (7). Clinical symptoms include impaired speech, dysphagia, visual 
and sensory deficits, cognitive impairments, altered muscle tone with spasticity, and inability 
to walk or grasp objects (10). 
Motor dysfunction, low muscle strength, joint stiffness, muscular hypertonia, and muscle 
contracture are common complications post-stroke (11–13). Post-stroke upper limb spasticity 
frequently involves involuntary wrist and finger flexor contraction, limiting muscle 
lengthening and prehensile grasping (14,15) (16,17). Approximately 85% of stroke patients 
experience delayed upper limb recovery, with wrist spasticity affecting 4–46% in chronic 
stages (18,19). 
Rehabilitation through targeted exercises, occupational therapy, and constrained-induced 
movement therapy improves motor recovery (20,21). Orthotic interventions, including static 
and dynamic splints, prevent deformities, relieve spasticity, and enhance hand function (22,23). 
Dynamic splints utilize springs or pulleys to provide gentle, adjustable stretching, and have 
shown superior efficacy in reducing spasticity when used 6 hours daily (24,25). Despite 
evidence supporting both types, direct comparisons remain limited (26,27). 
Rationale 
This study evaluates the comparative effectiveness of static and dynamic wrist-hand splints in 
post-stroke rehabilitation, aiming to provide evidence-based guidance for clinicians to 
optimize treatment strategies and patient outcomes. 
Materials and Methods 

Study Design: A randomized controlled trial (RCT) compared static versus dynamic wrist-
hand splints on spasticity, functional hand recovery, and pain in subacute stroke patients. 
Setting: Markaz Bahali-E-Mazooran Rehabilitation Center, Faisalabad, with trained 
physiotherapists and occupational therapists supervising interventions. 
Study Duration: Nine months; each participant underwent a structured 4-week intervention 
with assessments at baseline and post-intervention. 
Sample Size: 25 participants initially targeted; after adjustment for dropout, 20 participants 
(10 per group) completed the study. 
Sampling Technique: Purposive sampling; participants randomly assigned to groups via 
computer-generated randomization. 
Inclusion Criteria: Adults 30–65 years, diagnosed with hemiplegic stroke within last 6 
months, moderate to severe wrist spasticity (MAS ≥1). 
Exclusion Criteria: Severe neurological or musculoskeletal disorders, cognitive impairment, 
contraindications to splint use, or inability to comply with protocols. 
Outcome Measures: MAS, pain scores, grip strength, functional outcomes, and patient 
satisfaction at baseline and week 4. 
Statistical Analysis: Paired t-tests, Wilcoxon signed-rank tests, Mann-Whitney U tests, and 
repeated-measures ANCOVA used to evaluate changes and compare groups. 
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