Influence of Functional Electrical Stimulation (FES) on Neurogenic Foot Drop in Adolescent and Adult Patients with Infantile Cerebral Palsy

• Conditions: Infantile Cerebral Palsy; G80; Cerebral palsy

• Registration Number: DRKS00034470
• Lead Sponsor: niversitätsklinikum Heidelberg; Klinik für Orthopädie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-10-20
• Study Start: 2024-06-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Gross Motor Function Classification System (GMFCS) levels I to III.
- Neurogenic equinus deformity up to a maximum of 5 degrees in knee extension.
- Walking distance > 10 meters without aids.
- Compliance: Adherence to treatment protocols.
- Muscle strength grade (Tibialis anterior) < 4.
- Knee flexion contracture < 10 degrees.
- Hip flexion contracture < 20 degrees.

Exclusion Criteria

- Patient is 16 years old or younger.
- Surgery or botulinum toxin injection in the lower extremities within the last 6 months.
- Presence of: knee endoprosthesis, pacemaker, or other implanted electrical devices.
- Pregnancy.
- Epilepsy.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in dynamic equinus deformity in instrumented 3D gait analysis with and without the FES system, determined at the time of study enrollment and after three months.<br>Outcome measure: Range of motion of the ankle

Secondary Outcome Measures

Name	Time	Method
Changes in spasticity in instrumented 3D gait analysis with and without the FES system, determined at the time of study enrollment and after three months.<br>Outcome measure: EMG activity of the gastrocnemius muscle.<br><br>2. Satisfaction with Assistive Devices, QUEST Scores (Quebec User Evaluation of Satisfaction with Assistive Technology).