Static Versus Dynamic Splints for Wrist Spasticity in Stroke Patients

NCT07301606 | Completed

• 1 other identifier: UOL/IREB/25/09/0030
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia; Post Stroke Recovery; Stroke; Spasticity

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Arm 1 (Static wrist-hand splint)

EXPERIMENTAL

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

Arm 2 (Dynamic wrist-hand splint)

EXPERIMENTAL

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

Interventions

Static Wrist-Hand Splint DEVICE

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.

Arm 1 (Static wrist-hand splint)

Dynamic Wrist-Hand Splint DEVICE

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.

Arm 2 (Dynamic wrist-hand splint)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Markaz Bahali-e- Mazooran

Faisalabad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 24, 2025
• Study Start: October 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 15, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)