Static Versus Dynamic Splints for Wrist Spasticity in Stroke Patients

Static Versus Dynamic Wrist-Hand Splints to Reduce Wrist Spasticity in Subacute Hemiplegic Stroke Patients: A Randomized Control Trial

The goal of this clinical trial is to evaluate whether different types of wrist-hand splints can reduce wrist flexor spasticity in subacute hemiplegic stroke patients. The main questions it aims to answer are:

• Does a dynamic wrist-hand splint reduce wrist spasticity more effectively than a static splint?
• Does one type of splint lead to better functional outcome during use? Researchers will compare participants who receive a static splint with those who receive a dynamic splint to see which splint provides greater improvement in wrist spasticity.

Participants will:

• Wear either a static or dynamic wrist-hand splint according to the assigned study group.
• Undergo wrist spasticity assessments before and after the intervention using a standardized clinical scale.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiplegia; Spasticity; Post Stroke Recovery
• Intervention / Treatment: Device: Static Wrist-Hand Splint; Device: Dynamic Wrist-Hand Splint

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Faisalabad, Punjab Province, Pakistan
      • Markaz Bahali-e- Mazooran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 30-65 years
• Diagnosis of subacute stroke (e.g., 1-6 months post-stroke)
• Presence of wrist flexor spasticity
• Ability to follow simple instructions

Exclusion Criteria:

• Fixed wrist contracture
• Severe pain limiting splint use
• Other neurological or musculoskeletal disorders affecting the upper limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (Static wrist-hand splint); Participants in this arm will receive a static wrist-hand splint, which is designed to hold the wrist and fingers in a fixed position. The splint is worn according to the rehabilitation protocol, typically for several hours per day, to help maintain joint alignment, prevent contractures, and reduce wrist flexor spasticity. Participants will undergo wrist spasticity assessments at baseline and at the end of the intervention period.	Device: Static Wrist-Hand Splint; Intervention 1: The static wrist-hand splint is a rigid device that holds the wrist and fingers in a fixed position. It is custom-fitted to each participant and worn according to a defined rehabilitation protocol, typically for several hours per day. The static splint provides continuous support to prevent wrist flexor contractures and reduce spasticity. The primary focus is on maintaining proper joint alignment and minimizing muscle hypertonicity.
Experimental: Arm 2 (Dynamic wrist-hand splint); Participants in this arm will receive a dynamic wrist-hand splint, which applies gentle, graded extension forces to the wrist and fingers while allowing limited movement. The splint is worn according to the rehabilitation protocol, typically for several hours per day, to reduce wrist flexor spasticity and improve wrist positioning. Participants will undergo wrist spasticity assessments at baseline and at the end of the intervention period.	Device: Dynamic Wrist-Hand Splint; Intervention 2: The dynamic wrist-hand splint is a device designed to allow controlled, graded wrist and finger extension while limiting excessive flexion. It is custom-fitted to each participant and worn according to a rehabilitation protocol, typically for several hours per day. It permits movement within a safe range while applying gentle extension forces to reduce wrist flexor spasticity. This intervention aims to actively modulate muscle tone while maintaining functional mobility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrist Flexor Spasticity	Wrist flexor spasticity will be assessed using the Modified Ashworth Scale (MAS). Assessments will be performed at baseline before the intervention and after completion of the intervention period. The primary outcome is the change in MAS score, comparing participants using static versus dynamic wrist-hand splints.	Baseline to post-intervention (4 weeks)

Collaborators and Investigators

• Sponsor: University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): November 15, 2025

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Stroke; Hemiplegia
• Other Study ID Numbers: UOL/IREB/25/09/0030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves a small number of patients with subacute stroke, and sharing de-identified data could risk participant privacy. Additionally, the data were collected for this specific study and yet no plans have been made to create a broader data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No