Multi-pad FES System for Drop Foot Treatment

University of Belgrade

Status: Completed

Conditions: Foot Drop

Treatments: Other: Conventional therapy; Device: multi-pad functional electrical stimulation (FES)

Study type: Interventional

Funder types: Other

Identifiers

NCT02729636

LK-4

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

FES:a

Experimental group

Description:

The group will be treated with multipad electrical stimulation device.

Treatment:

Device: multi-pad functional electrical stimulation (FES)

control

Active Comparator group

Description:

The group will be treated with conventional treatment.

Treatment:

Other: Conventional therapy