The Effect of a Comprehensive Rehabilitation Program Using Robotic Walking and Functional Electrical Stimulation Technologies on Balance and Walking in Children With Cerebral Palsy

Recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT06403891
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

The aim of this study was to investigate the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and gait in children with cerebral palsy. This study was planned as a prospective observational study. A total of 30 patients in two groups were planned to be included in the study. Patients in both groups were planned to receive a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. The case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (FES) and robotic rehabilitation applications in addition to the conventional rehabilitation program.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2024-04-24
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Being between the ages of 2-18
• Being diagnosed with cerebral palsy
• Walking independently with or without an assistive walking device
• Having a GMFCS score between 1-3
• Lack of seizure history
• Showing consent to participate in the study (signing the informed consent by the legal guardian of the patient)

Exclusion Criteria

• Presence of contracture in lower extremities
• Being administered botulinum toxin within the last one month before treatment or during the 6-week treatment period
• Being unable to cooperate with clinical assessments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Range of motion of joints during the gait cycle	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	Range of motion of the knee, hip and ankle joint during the gait cycle
Cadence	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	The number of steps taken per minute
Plantar surface pressure distribution	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	Plantar surface pressure distribution measured by pedobarograph
Stride length	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	The distance between the consecutive initial contacts of the same foot
Range of motion of the pelvis in the frontal plane during the gait cycle	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	Range of motion of the pelvis in the frontal plane during the gait cycle
Step length	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	The distance between the initial contact of one foot and the initial contact of the contralateral foot
Track width	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	The mediolateral distance between right and left heels during gait

Secondary Outcome Measures

Name	Time	Method
Spasticity	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	Spasticity will be assessed with the Modified Ashworth Scale
Balance	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	Balance will be assessed with the Pediatric Berg Balance Scale
Gait speed	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program	Gait speed will be assessed with the 10-meter walk test

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey