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

NCT ID: NCT06403891

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2024-05-15

Brief Summary

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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

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Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

The control group was planned to consist of patients who received 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.

No interventions assigned to this group

Case

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 that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berat M Alkan, Professor

Role: CONTACT

+90 312 552 60 00

Facility Contacts

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Berat M Alkan, Professor

Role: primary

+90 312 552 60 00

Other Identifiers

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E2-22-1398

Identifier Type: -

Identifier Source: org_study_id

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