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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06403891
Enrollment
30
Registered
2024-05-08
Start date
2022-03-15
Completion date
2024-05-15
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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.

Interventions

None listed

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plantar surface pressure distributionThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programPlantar surface pressure distribution measured by pedobarograph
Track widthThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programThe mediolateral distance between right and left heels during gait
Range of motion of joints during the gait cycleThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programRange of motion of the knee, hip and ankle joint during the gait cycle
Range of motion of the pelvis in the frontal plane during the gait cycleThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programRange of motion of the pelvis in the frontal plane during the gait cycle
CadenceThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programThe number of steps taken per minute
Step lengthThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programThe distance between the initial contact of one foot and the initial contact of the contralateral foot
Stride lengthThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programThe distance between the consecutive initial contacts of the same foot

Secondary

MeasureTime frameDescription
BalanceThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programBalance will be assessed with the Pediatric Berg Balance Scale
Gait speedThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programGait speed will be assessed with the 10-meter walk test
SpasticityThe first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation programSpasticity will be assessed with the Modified Ashworth Scale

Countries

Turkey (Türkiye)

Contacts

Primary ContactBerat M Alkan, Professor
beratalkan73@gmail.com+90 312 552 60 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026