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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markaz Bahali-e- Mazooran | Faisalabad | Punjab Province | Pakistan |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2025 | Dec 10, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |