Multi-pad FES System for Drop Foot Treatment

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 22, 2018

Primary Completion Date

November 10, 2021

Study Completion Date

November 10, 2021

Conditions
Foot Drop
Interventions
DEVICE

multi-pad functional electrical stimulation (FES)

"Treatment includes two automated phases: optimization of stimulation parameters and application during the walk.~Optimization of stimulation parameters: The stimulator generates short bursts of electrical impulses and sends them to each of the 16 pads of the multi-pad electrode. Each pad is the same size. Pads are sorted in two rows by 8 pads. Common anode is placed under the knee. Based on FES-induced foot movements, automated algorithm suggests parameters which are evaluated by medical doctor/therapist.~Assisted walking: During assisted walking, pattern for plantar flexion is activated in push off phase and pattern for dorsiflexion in swing phase of the gait."

OTHER

Conventional therapy

2\. All study subjects received the conventional stroke rehabilitation program of physiotherapy based on the neurodevelopmental facilitation approach and occupational therapy focused on activities of daily living during the treatment for 60 min a day, 5 days a week, for 4-weeks. Conventional therapy was given by trained therapists and consisted of the following strategies: strategies to joint mobilization and range of motion exercises; exercises to improve strength; strategies to manage spasticity; exercises for increase range of motion, compensatory strategy; strategies to improve balance, and mobility.

Trial Locations (1)

11000

Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade, Belgrade

All Listed Sponsors
lead

University of Belgrade

OTHER

NCT02729636 - Multi-pad FES System for Drop Foot Treatment | Biotech Hunter | Biotech Hunter