NCT02729636

Multi-pad FES System for Drop Foot Treatment

Multi-pad Functional Electrical Stimulation for Droop Foot Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Belgrade · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Functional electrical stimulation (FES) is multi-pad system that allows fast optimization of stimulation patterns for achieving strong dorsiflexion/plantar flexion and automatic real-time control of ankle joint during FES assisted walking. The main aim of the present study is to compare the effects of functional electrical stimulation gait training after stroke and overground conventional physical therapy. With the assumption that the advanced method of functional electrical stimulation will improve gait parameters and functionality in patients with foot drop before and after FES treatment the objectives of this study are to examine the effects of functional electrical stimulation using FES:a method on indicators of walk and function in patients with foot drop before and after FES treatment.

Conditions

• Foot Drop

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-22
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2016-04-06
• Last updated: 2021-11-16

Locations

1 site across 1 country: Serbia