StrokeNCT07301606
Static Versus Dynamic Splints for Wrist Spasticity in Stroke Patients
A study testing Static Wrist-Hand Splint and Dynamic Wrist-Hand Splint in people with Stroke and Spasticity, run by University of Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stroke, Spasticity, Hemiplegia
- What is being tested?
- Static Wrist-Hand Splint and Dynamic Wrist-Hand Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2025to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Fixed wrist contracture
- Severe pain limiting splint use
- Other neurological or musculoskeletal disorders affecting the upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Static Wrist-Hand Splint, Dynamic Wrist-Hand Splint
- Medical subject headings
- Stroke, Muscle Spasticity, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Wrist-Hand SplintDevice
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.
Dynamic Wrist-Hand SplintDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dynamic Wrist-Hand Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Oct 2025
- Primary completion31 Oct 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Ameer, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301606
- Sponsor's protocol ID
- UOL/IREB/25/09/0030
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static Versus Dynamic Wrist-Hand Splints to Reduce Wrist Spasticity in Subacute Hemiplegic Stroke Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07301606
- Acronym / sponsor ID
- UOL/IREB/25/09/0030
- Conditions
- Stroke, Spasticity, Hemiplegia, Post Stroke Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Static wrist-hand splint) | Experimental | Device: Static Wrist-Hand SplintParticipants 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. |
| Arm 2 (Dynamic wrist-hand splint) | Experimental | Device: Dynamic Wrist-Hand SplintParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Fixed wrist contracture
- Severe pain limiting splint use
- Other neurological or musculoskeletal disorders affecting the upper limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static Wrist-Hand SplintIntervention 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. | Device | Arm 1 (Static wrist-hand splint) |
| Dynamic Wrist-Hand SplintIntervention 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. | Device | Arm 2 (Dynamic wrist-hand splint) |
Primary outcome
Wrist Flexor Spasticity
Time frame: Baseline to post-intervention (4 weeks)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Wrist-Hand Splint and Dynamic Wrist-Hand Splint in people with Stroke and Spasticity, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist Flexor Spasticity (time frame: Baseline to post-intervention (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.