Clinical trial NCT06403891: The Effect of a Comprehensive Rehabilitation Program Using Robotic Walking and Functional Electrical Stimulation Technologies on Balance and Walking in Children With Cerebral Palsy
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 2-18, diagnosed with cerebral palsy, receiving inpatient treatment in Ankara Bilkent City Hospital

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.


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

Primary outcomes:
measure: Cadence
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Step length
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Stride length
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Track width
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Range of motion of joints during the gait cycle
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Range of motion of the pelvis in the frontal plane during the gait cycle
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Plantar surface pressure distribution
timeFrame: 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 outcomes:
measure: Spasticity
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Balance
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
measure: Gait speed
timeFrame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References: