NCT07720609

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Jul 2026Sep 2026

First Submitted

Initial submission to the registry

July 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2026

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 18, 2026

Last Update Submit

July 18, 2026

Conditions

Chronic Stroke Patient

Keywords

Chronic StrokeStroke RehabilitationTele-rehabilitationModified Constraint-Induced Movement Therapy

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity Fugl-Meyer Assessment (UEFMA)

    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

Study Arms (2)

group A Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy

EXPERIMENTAL

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

group B Clinic-Based Modified Constraint-Induced Movement Therapy

ACTIVE COMPARATOR

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

Interventions

Tele-Rehabilitation-Based Modified Constraint-Induced Movement TherapyBEHAVIORAL

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.

group A Tele-Rehabilitation-Based Modified Constraint-Induced Movement Therapy
Clinic-Based Modified Constraint-Induced Movement TherapyBEHAVIORAL

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.

group B Clinic-Based Modified Constraint-Induced Movement Therapy

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shadman Medical Center, Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

  • Kainat Tariq, MSPTN

    The University of Lahore, Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kainat Tariq, MSPTN

CONTACT

03328256500kainattariq06@gmail.com

Montiha Azeem, MSPTN

CONTACT

03479717317muntahaazeem9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 18, 2026

First Posted

July 22, 2026

Study Start

July 18, 2026

Primary Completion (Estimated)

September 6, 2026

Study Completion (Estimated)

September 6, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

PA(1)