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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06403891
• Other study ID #: E2-22-1398
• Status: Recruiting
• Start date: March 15, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: Berat M Alkan, Professor
• Phone: +90 312 552 60 00
• Email: beratalkan73[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cadence	The number of steps taken per minute	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Primary	Step length	The distance between the initial contact of one foot and the initial contact of the contralateral foot	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Primary	Stride length	The distance between the consecutive initial contacts of the same foot	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Primary	Track width	The mediolateral distance between right and left heels during gait	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Primary	Range of motion of joints during the gait cycle	Range of motion of the knee, hip and ankle joint 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
Primary	Range of motion of the pelvis in the frontal plane during the gait cycle	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
Primary	Plantar surface pressure distribution	Plantar surface pressure distribution measured by pedobarograph	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Secondary	Spasticity	Spasticity will be assessed with the Modified Ashworth Scale	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Secondary	Balance	Balance will be assessed with the Pediatric Berg Balance Scale	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Secondary	Gait speed	Gait speed will be assessed with the 10-meter walk test	The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program