TELE-REHABILITATION VERSUS CLINIC-BASED MODIFIED CONSTRAINT-INDUCED MOVEMENT THERAPY FOR UPPER LIMB FUNCTION IN CHRONIC STROKE PATIENTS (TELE-mCIMT)

July 18, 2026 updated by: Kainat Tariq

Stroke commonly results in persistent upper limb impairment that limits functional independence and participation in daily activities. Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based intervention for improving upper limb function after stroke. Tele-rehabilitation has emerged as an alternative method of delivering rehabilitation services, potentially improving accessibility while maintaining treatment effectiveness.

This randomized controlled trial will compare the effectiveness of tele-rehabilitation-based mCIMT with clinic-based mCIMT in individuals with chronic stroke. Sixty-eight eligible participants will be randomly allocated into two groups. The tele-rehabilitation group will receive supervised mCIMT through virtual sessions combined with a structured home exercise program, while the clinic-based group will receive the same intervention in a clinical setting. Both groups will receive treatment three times per week for 6 weeks.

Upper limb function, spasticity, motor performance, and intrinsic motivation will be assessed at baseline and after the 6-week intervention using the Upper Extremity Fugl-Meyer Assessment (UEFMA), Modified Ashworth Scale (MAS), Wolf Motor Function Test (WMFT), and Intrinsic Motivation Inventory (IMI). The study aims to determine whether tele-rehabilitation is as effective as clinic-based mCIMT for improving upper limb function in individuals with chronic stroke.

Study Overview

Status

Status

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

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.

Detailed Description

This study is a single-center, randomized controlled trial designed to compare the effectiveness of tele-rehabilitation-based modified Constraint-Induced Movement Therapy (mCIMT) with clinic-based mCIMT in individuals with chronic stroke. A total of 68 participants meeting the eligibility criteria will be recruited from the University of Lahore Teaching Hospital and randomly allocated into two groups using the sealed envelope method. Outcome assessors will remain blinded to group allocation.

Participants in the tele-rehabilitation group will attend an initial in-person assessment followed by supervised virtual rehabilitation sessions. The intervention will include heat application, self-stretching, active-assisted range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy. Participants will perform functional upper limb activities while wearing a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home.

Participants in the clinic-based group will receive the same rehabilitation components, including heat application, stretching, range of motion exercises, and task-oriented modified Constraint-Induced Movement Therapy, delivered face-to-face in the rehabilitation clinic. Treatment sessions will be conducted three times per week for 6 weeks, with home practice using the constraint mitt for 4 hours daily.

Outcome assessments will be performed at baseline and after completion of the 6-week intervention. The primary outcome measures will include upper limb motor function assessed using the Upper Extremity Fugl-Meyer Assessment (UEFMA) and spasticity assessed using the Modified Ashworth Scale (MAS). Secondary outcome measures will include the Wolf Motor Function Test (WMFT) and the Intrinsic Motivation Inventory (IMI). The study will evaluate whether tele-rehabilitation-based mCIMT provides comparable or superior improvements in upper limb function, motor performance, spasticity, and motivation compared with clinic-based mCIMT in individuals with chronic stroke.

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 (Estimated)

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.
68

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • Shadman Medical Center, Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kainat Tariq, MSPTN

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:

  • Participant with age from 35 to 75 years
  • Both gender
  • Patients after 6 month of stroke.
  • Participant with flexion and abduction at shoulder minimum 10-15 degree and 5-10 degree at wrist and thumb/digit.
  • Participants with access to a smartphone or laptop with internet connectivity and the ability to use it for tele-rehabilitation sessions.
  • Participant with modified ashworth scale score of 2 or higher.
  • Participants who have internet access and can also engage in video conferences.

Exclusion Criteria:

  • Patient with any neurological issues apart from stroke that might impact motor function.
  • Patient who is not able to follow the commands or are unable to cooperate.
  • Patient with any autoimmune disorder like rheumatoid arthritis that might impact arm function.
  • Patient with history of epilepsy. Participant who are involved in any fitness program that can improve upper extremity function.

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: Double

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: group A Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation. The intervention will include supervised virtual sessions consisting of heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities. Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home. Treatment will be provided 3 sessions per week for 6 weeks.
Behavioral: Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered through tele-rehabilitation. The intervention will include supervised virtual sessions comprising heat application, self-stretching, active-assisted range of motion exercises, and task-oriented functional activities. Participants will wear a constraint mitt on the unaffected upper limb during supervised sessions and for 4 hours daily at home. Treatment will be delivered 3 sessions per week for 6 weeks.
Active Comparator: group B Clinic-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting. The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision. Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and for 4 hours daily at home. Treatment will be provided 3 sessions per week for 6 weeks.
Behavioral: Clinic-Based Modified Constraint-Induced Movement Therapy
Participants will receive modified Constraint-Induced Movement Therapy (mCIMT) delivered in a clinical setting. The intervention will include heat application, stretching, range of motion exercises, and task-oriented functional activities under therapist supervision. Participants will wear a constraint mitt on the unaffected upper limb during treatment sessions and continue constraint use for 4 hours daily at home. Treatment will be delivered 3 sessions per week for 6 weeks.

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
Upper Extremity Fugl-Meyer Assessment (UEFMA)
Time Frame: Baseline and Week 6
The Upper Extremity Fugl-Meyer Assessment (UEFMA) will be used to evaluate upper limb motor recovery. Changes in UEFMA scores from baseline to the end of the 6-week intervention will be compared between the tele-rehabilitation and clinic-based modified Constraint-Induced Movement Therapy groups.
Baseline and Week 6

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.
Kainat Tariq

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kainat Tariq, MSPTN, The University of Lahore, 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 (Estimated)

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.
July 18, 2026

Primary Completion (Estimated)

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.
September 6, 2026

Study Completion (Estimated)

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.
September 6, 2026

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).
July 18, 2026

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.
July 18, 2026

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.
July 22, 2026

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.
July 22, 2026

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.
July 18, 2026

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.
July 1, 2026

More Information

Terms related to this study

Keywords

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/25/09/0038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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