Multi-pad FES System for Drop Foot Treatment

Sponsor

University of Belgrade (Other)

Overall Status

Completed

CT.gov ID

NCT02729636

Collaborator

(none)

Enrollment

Location

Arms

36.6

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Foot Drop	Device: multi-pad functional electrical stimulation (FES) Other: Conventional therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Multi-pad Functional Electrical Stimulation for Droop Foot Treatment

Actual Study Start Date :

Oct 22, 2018

Actual Primary Completion Date :

Nov 10, 2021

Actual Study Completion Date :

Nov 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FES:a The group will be treated with multipad electrical stimulation device.	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.
Active Comparator: control The group will be treated with conventional treatment.	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.

Arm

Intervention/Treatment

Experimental: FES:a

The group will be treated with multipad electrical stimulation device.

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.

Active Comparator: control

The group will be treated with conventional treatment.

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.

Outcome Measures

Primary Outcome Measures

gait speed by 10m walking test [4 weeks]

Secondary Outcome Measures

motor arm impairment by Fugl Mayer assessment [4 weeks]
Activities of daily living by Barthel index [4 weeks]
postural stability by Berg Balance scale [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

hemiplegia caused by stroke
inadequate ankle dorsiflexion
passive ankle range of motion to neutral position
adequate cognitive and communication function to give informed consent
sufficient motor ability and endurance to ambulate at least 6 minutes of walking independently with or without an assistive device
calf muscle spasticity not higher than grade 3 according to the Modified Ashworth Scale

Exclusion Criteria:

lower motor neuron injury with inadequate response to stimulation
skin rupture in the area of the electrodes
history of falls greater than once a week
multiple or infratentorial cerebrovascular lesions
severe cardiovascular disease, severe auditory and visual impairments
inadequate response to stimulation (range of motion elicit by maximal pleasant stimulation lower than active range in first 5 days of the therapy).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade	Belgrade		Serbia	11000

Sponsors and Collaborators

University of Belgrade

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Konstantinovic Ljubica, professor, University of Belgrade

ClinicalTrials.gov Identifier:

NCT02729636

Other Study ID Numbers:

LK-4

First Posted:

Apr 6, 2016

Last Update Posted:

Nov 16, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peroneal Neuropathies

Study Results

No Results Posted as of Nov 16, 2021