Static Versus Dynamic Splints for Wrist Spasticity in Stroke Patients

December 10, 2025 updated by: Asma Ameer, University of Lahore

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to post-intervention (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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