Not Yet Recruiting

NCT Number: NCT06658275

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Movement Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Constraint-induced movement therapy

Other

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.

Hand Arm Bimanual Intensive Training -HABIT

Other

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

Primary outcomes

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.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Kashif, PhD-PT

CONTACT

[email protected]

+923333125303

Nubtahil Laraib, DPT

CONTACT

[email protected]

+923110712132

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 26, 2024
Registry last updated: Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting