Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For CP

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT06658275
• Lead Sponsor: Riphah International University

Brief Summary

Cerebral palsy is a neurological condition affecting movement and posture, caused by non-progressive brain disruptions occurring during fetal development. Constraint-induced movement therapy (CIMT) significantly improves arm and hand function in children with hemiparetic cerebral palsy by using intensive therapy sessions and restricting the unaffected limb to develop new motor skills. Bimanual therapy involves using both hands repeatedly to perform functional tasks, rather than relying on just one hand. Tele-rehabilitation (TR) is an affordable method of providing remote rehabilitation services through telecommunication technologies like smartphones and media applications. The aim of the study is to compare the effectiveness of CIMT and bimanual therapy delivered via tele-rehabilitation for improving upper limb function in children with cerebral palsy.

This randomized clinical trial will be conducted at Mubarik Medical Complex, Sargodha, Pakistan, with a sample size of 65. Participants will be randomly allocated into two groups using an online randomization tool, Group A will receive constraint-induced movement therapy (CIMT) intervention for 60 minutes, and Group B will receive bimanual therapy intervention for 60 minutes. Each participant will undergo treatment for three days a week on alternate days for eight weeks.

Spasticity will be assessed by using the Modified Ashworth Scale. The Quality of Upper Extremity Skills Test (QUEST) will evaluate dissociated movement, grasp, protective extension, and weight bearing, while the Tele-Rehabilitation Satisfaction Survey (TeSS) is designed to evaluate the experiences and satisfaction levels of patients or caregivers who have participated in tele-rehabilitation programs. Measurements will be taken at baseline, 4th week, 8th week, and at 12th week after discontinuation of treatment. The data will be entered and assessed using SPSS 26. For between-group analysis of parametric data, the independent t-test will be used, while non-parametric data will be analyzed using the Mann-Whitney test. Within-group comparisons will be conducted using repeated measures ANOVA for parametric data and Friedman ANOVA for non-parametric data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Status Verified: 2024-11
• Study Start: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Age 6-12 years.

• Children with hemiplegic cerebral palsy with mild to moderate hand involvement.

• Ability to extend wrist >20° and fingers at the metacarpophalangeal joints

  >10° from full flexion

• Demonstrated ability to follow instructions during screening and complete the testing.

• Spasticity does not exceed a score of 1 or 1+ on the Modified Ashworth Scale

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Exclusion Criteria

• Health problems unassociated with CP.
• Visual problems interfering with treatment.
• Active or unstable seizures.
• Orthopedic surgery on the more affected hand within the last year.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality Of Upper Extremity Skills Test (QUEST)	8 weeks	The Quality of Upper Extremity Skills Test (QUEST) was developed in 1991 specifically to address the needs of children with spastic cerebral palsy. It is a criterion-referenced assessment tool designed to measure the quality of upper limb movements. The test comprises 34 items, which are organized into four distinct domains. These domains collectively evaluate various aspects of upper extremity function. Administering and scoring the QUEST typically takes between 30 and 45 minutes.
Telehealth Satisfaction Scale	8 weeks	The Telehealth Satisfaction Scale (TeSS) is a standardized tool designed to assess patient satisfaction with telehealth services. It evaluates aspects such as the quality of care, ease of use of telehealth technology, interaction with healthcare providers, and overall telehealth experience.