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Multi-pad FES System for Drop Foot Treatment

Primary Purpose

Foot Drop

Status

Completed

Phase

Not Applicable

Locations

Serbia

Study Type

Interventional

Intervention

multi-pad functional electrical stimulation (FES)

Conventional therapy

About this trial

This is an interventional treatment trial for Foot Drop

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FES:a

control

Arm Description

The group will be treated with multipad electrical stimulation device.

The group will be treated with conventional treatment.

Outcomes

Primary Outcome Measures

gait speed by 10m walking test

Secondary Outcome Measures

motor arm impairment by Fugl Mayer assessment

Activities of daily living by Barthel index

postural stability by Berg Balance scale

Full Information

NCT ID

NCT02729636

First Posted

March 29, 2016

Last Updated

November 12, 2021

Sponsor

University of Belgrade

1. Study Identification

Unique Protocol Identification Number

NCT02729636

Brief Title

Multi-pad FES System for Drop Foot Treatment

Official Title

Multi-pad Functional Electrical Stimulation for Droop Foot Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 22, 2018 (Actual)

Primary Completion Date

November 10, 2021 (Actual)

Study Completion Date

November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Drop

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FES:a

Arm Type

Experimental

Arm Description

The group will be treated with multipad electrical stimulation device.

Arm Title

control

Arm Type

Active Comparator

Arm Description

The group will be treated with conventional treatment.

Intervention Type

Device

Intervention Name(s)

multi-pad functional electrical stimulation (FES)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

gait speed by 10m walking test

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

motor arm impairment by Fugl Mayer assessment

Time Frame

4 weeks

Title

Activities of daily living by Barthel index

Time Frame

4 weeks

Title

postural stability by Berg Balance scale

Time Frame

4 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

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

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

12. IPD Sharing Statement

Citations:

PubMed Identifier

28673311

Citation

Malesevic J, Dedijer Dujovic S, Savic AM, Konstantinovic L, Vidakovic A, Bijelic G, Malesevic N, Keller T. A decision support system for electrode shaping in multi-pad FES foot drop correction. J Neuroeng Rehabil. 2017 Jul 3;14(1):66. doi: 10.1186/s12984-017-0275-5.

Results Reference

derived

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Multi-pad FES System for Drop Foot Treatment

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