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

Influence of functional electrical stimulation (FES) in adult patients with diseases of the first motor neuron - FES-Orthese-GRK

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034437

Enrollment

Registered

2024-06-12

Start date

2023-02-28

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

infantile cerebral palsy stroke multiple sclerosis Traumatic brain injury Paraplegia

Interventions

Group 1: Newly equipped patients with the FES system will undergo an instrumented 3D gait analysis, along with additional questionnaires and a clinical examination, upon receiving the system and after

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. Example outcome measure: ankle joint kinematics throughout the gait cycle.	—

Secondary

Measure	Time frame
Comparison of initial assessment to final assessment after three months. Objective parameters: 1. Proprioception, deviation from target to actual position in angle reproduction, measured using instrumented 3D motion analysis. Subjective parameters: 1. Quality of life, SF-12 scores (Short Form 12). 2. Satisfaction with assistive devices, QUEST scores (Quebec User Evaluation of Satisfaction with Assistive Technology). 3. Impact of dual tasks on daily activities, DIDA-Q score (Dual-task Impact on Daily-living Activities Questionnaire). 4. Toe dragging/falls, scores based on the number of toe drags/falls over a two-week period.	—

Measure

Time frame

Comparison of initial assessment to final assessment after three months. Objective parameters: 1. Proprioception, deviation from target to actual position in angle reproduction, measured using instrumented 3D motion analysis. Subjective parameters: 1. Quality of life, SF-12 scores (Short Form 12). 2. Satisfaction with assistive devices, QUEST scores (Quebec User Evaluation of Satisfaction with Assistive Technology). 3. Impact of dual tasks on daily activities, DIDA-Q score (Dual-task Impact on Daily-living Activities Questionnaire). 4. Toe dragging/falls, scores based on the number of toe drags/falls over a two-week period.

—

Countries

Germany

Contacts

Public ContactNiklas Bleichner

Universitätsklinikum Heidelberg; Klinik für Orthopädie

niklas.bleichner@med.uni-heidelberg.de+49 6221 56-34528

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026