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Clinical Trials/NCT06403891
NCT06403891
Recruiting
N/A

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

Ankara City Hospital Bilkent1 site in 1 country30 target enrollmentMarch 15, 2022
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Ankara City Hospital Bilkent
Enrollment
30
Locations
1
Primary Endpoint
Range of motion of joints during the gait cycle
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2022
End Date
May 15, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Range of motion of joints during the gait cycle

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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)

Study Sites (1)

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