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

November 19, 2024 updated by: Riphah International University

Comparison of Constraint-Induced Movement Therapy And Bimanual Intensive Therapy Through Tele-rehabilitation For Upper Limb Functions In Children With Hemiplegic Cerebral Palsy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • 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 Backup

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A (Constraint-Induced Movement Therapy)
Participants will undergo Constraint-Induced Movement Therapy(one hour), which will be administered by their parents under the guidance of a therapist through tele- rehabilitation for 3 days in a week for 8 weeks
Other: Constraint-induced movement therapy
During the first routine checkup, therapists will educate caregivers on how to perform the exercises and activities at home. Caregivers will place the childrens less-affected hands in slings and guide them through exercises designed to engage their weaker, paretic hands. The sling will be fastened around the childrens trunks, with the end securely closed.After the initial session, the intervention will be provided by the caregiver at home, with progress monitored by the therapist through Zoom meetings or WhatsApp video calls. Children will engage in play-based activities as part of the CIMT program to improve upper limb functions.These activities will include painting, pin the tail on the donkey for sensory awareness and proprioception, card games, bubble activities, squeezing sponges, building towers with blocks, playing a curtained box game, using tongs, and picking up coins. Exercises will be gradually progressed from easier to more challenging tasks as the child improves.
Experimental: GROUP B (Bi-manual intensive therapy)
Participants will undergo Bimanual therapy(one hour), which will be administered by their parents under the guidance of a therapist through tele-rehabilitation for 3 days in a week for 8 weeks.
Other: Hand Arm Bimanual Intensive Training -HABIT
For the Bimanual Intensive Training group, a strategy similar to HABIT will be used. At the first routine checkup, therapists will educate caregivers on the exercises, which will then be conducted at home. Caregivers will guide children through specially designed bimanual activities without slings, focusing on tasks like reaching, grasping, manipulation, releasing, and bearing weight on the upper limb. Progress will be monitored remotely through Zoom or WhatsApp video calls.Exercises will include catching and throwing a ball to improve reaching, grasp, and release; squeezing a textured ball for sensory awareness and sustained grip; stabilising and reorienting paper while drawing and cutting to enhance forearm supination and wrist extension. Additional tasks like sticker peeling for pincer grip and dough playing for hand manipulation will also be included.Exercises will progress from easy to more difficult as the child improves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality Of Upper Extremity Skills Test (QUEST)
Time Frame: 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.
8 weeks
Telehealth Satisfaction Scale
Time Frame: 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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/24/0234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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