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Recruiting NCT07604181

Comparative Effects of Telerehabilitation and Clinic Based Constraint Induced Movement Therapy on Upper Limb Function in Sub-Acute Stroke Patients

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Constraint-Induced Movement Therapy within a clinical setting, Constraint-Induced Movement Therapy Via Telerehabilitation.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Constraint-Induced Movement Therapy within a clinical setting
    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.
  • Procedure Constraint-Induced Movement Therapy Via Telerehabilitation
    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.

Primary outcome measures

  • Wolf motor function test [Time frame: 8 weeks]
  • Action research arm test [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

\- 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.

5\. 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.

Exclusion criteria

  • Severe cognitive impairment. 2. Severe spasticity (Modified Ashworth Scale score \>3). 3. Other neurological or musculoskeletal disorders affecting upper limb function.

4\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Madinah Teaching Hospital — Faisalabad

Identifiers

NCT: NCT07604181 · TUF/EIRB/173/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗