NCT07604181

Brief Summary

Stroke constitutes a principal cause of chronic neurological disability globally, frequently precipitating profound upper limb motor impairment that compromises functional autonomy and overall quality of life. Constraint-Induced Movement Therapy (CIMT) represents a rigorously validated neurorehabilitation paradigm grounded in the doctrine of experience-dependent neuroplasticity, promoting cortical reorganization through enforced utilization of the paretic limb while restraining the unaffected extremity. By counteracting learned non-use and emphasizing high- intensity, task-specific training, CIMT substantially augments motor recovery and functional performance. The primary objective of the present study is to comparatively evaluate the efficacy of CIMT delivery-clinic-based rehabilitation and telerehabilitation-in individuals with stroke. A total of 28 participants will be recruited through a non-probability consecutive sampling technique in accordance with explicitly defined inclusion and exclusion criteria, and will subsequently be randomized into two equal groups (n = 14 per group) using the chit-and-draw method to ensure unbiased allocation. Group A will receive CIMT within a clinical setting under direct supervision, whereas Group B will undergo an equivalent intervention via a structured online telerehabilitation platform under complete supervision. The intervention will be administered to both groups for duration of eight weeks. Outcome measures will include the Action Research Arm Test (ARAT), the Wolf Motor Function Test (WMFT), and the Modified Ashworth Scale (MAS) to comprehensively evaluate upper limb motor function and spasticity. Assessments will be conducted at baseline and at the completion of the eight-week intervention period. Statistical analysis will be performed using SPSS version 23.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable stroke

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 Progress12%
May 2026Jul 2026

First Submitted

Initial submission to the registry

May 16, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 16, 2026

Last Update Submit

May 16, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Wolf motor function test

    8 weeks

  • Action research arm test

    8 weeks

Study Arms (2)

Constraint-Induced Movement Therapy within a clinical setting

EXPERIMENTAL
Procedure: Constraint-Induced Movement Therapy within a clinical setting

Constraint-Induced Movement Therapy Via Telerehabilitation

EXPERIMENTAL
Procedure: Constraint-Induced Movement Therapy Via Telerehabilitation

Interventions

it is clinic based treatment which includes Restraining the unaffected upper limb using a mitt or sling for approximately 5-6 hours per day to discourage learned non-use. Intensive, task-specific training of the affected upper limb focusing on functional activities such as reaching, grasping, lifting, gripping, pinching, and object manipulation.

Constraint-Induced Movement Therapy within a clinical setting

Online Structured Tele Rehabilitation based treatment which includes Restraining the unaffected upper limb using a mitt or sling for approximately 5-6 hours per day to discourage learned non-use. Intensive, task-specific training of the affected upper limb focusing on functional activities such as reaching, grasping, lifting, gripping, pinching, and object manipulation.

Constraint-Induced Movement Therapy Via Telerehabilitation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Diagnosed cases of ischemic or hemorrhagic stroke. 2. Age between 40-70 years. 3. Both male and female. 4. Presented with stroke for once in a life and in a period of 6 months post stroke.
  • \. Patient should not have any history of rehabilitation in his/her 6 months post stroke period. 6. Medically stable condition. 7. Ability to understand and follow simple verbal instructions. 8. Minimum active wrist and finger extension required to participate in CIMT.

You may not qualify if:

  • Severe cognitive impairment. 2. Severe spasticity (Modified Ashworth Scale score \>3). 3. Other neurological or musculoskeletal disorders affecting upper limb function.
  • \. Severe aphasia limiting effective communication. 5. Any other musculoskeletal deficits interfering with task performance. 6. Uncontrolled systemic medical conditions. 7. No attendant's support the session. 8. Depression that restrains participant to cooperate during the session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madinah Teaching Hospital

Faisalabad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Lieza Iftikhar

Study Record Dates

First Submitted

May 16, 2026

First Posted

May 22, 2026

Study Start

May 16, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations