MedPath

Influence of functional electrical stimulation (FES) in adult patients with diseases of the first motor neuro

Recruiting
Conditions
infantile cerebral palsystrokemultiple sclerosisTraumatic brain injuryParaplegia
Registration Number
DRKS00034437
Lead Sponsor
niversitätsklinikum Heidelberg; Klinik für Orthopädie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Unilateral neurogenic foot drop
- Walking duration of at least 15 minutes
- Muscle strength (tibialis anterior) < 4
- At least 5° dorsiflexion range of motion from the neutral zero position
- Knee extension deficit < 10°
- Hip extension deficit < 20°
- Capacity to consent

Exclusion Criteria

- Surgery or botulinum toxin infiltration of 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
NameTimeMethod
Changes in biomechanical parameters (kinematics, kinetics, spatio-temporal parameters) in the instrumented 3D gait analysis with and without the FES system, determined at the time of study inclusion and after three months.<br>Example outcome measure: ankle joint kinematics throughout the gait cycle.
Secondary Outcome Measures
NameTimeMethod
Comparison of initial assessment to final assessment after three months.<br><br>Objective parameters:<br>1. Proprioception, deviation from target to actual position in angle reproduction, measured using instrumented 3D motion analysis.<br><br>Subjective parameters:<br>1. Quality of life, SF-12 scores (Short Form 12).<br>2. Satisfaction with assistive devices, QUEST scores (Quebec User Evaluation of Satisfaction with Assistive Technology).<br>3. Impact of dual tasks on daily activities, DIDA-Q score (Dual-task Impact on Daily-living Activities Questionnaire).<br>4. Toe dragging/falls, scores based on the number of toe drags/falls over a two-week period.
© Copyright 2025. All Rights Reserved by MedPath