Static Versus Dynamic Splints for Wrist Spasticity in Stroke Patients

NCT ID: NCT07301606

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-11-15

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

Stroke; Spasticity; Hemiplegia; Post Stroke Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Static Wrist-Hand Splint

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Dynamic Wrist-Hand Splint

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Asma Ameer

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Markaz Bahali-e- Mazooran

Faisalabad, Punjab Province, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

UOL/IREB/25/09/0030

Identifier Type: -

Identifier Source: org_study_id