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Completed

NCT Number: NCT02729636

Multi-pad FES System for Drop Foot Treatment

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.

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Key information

Conditions

Foot Drop Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Peroneal Neuropathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

multi-pad functional electrical stimulation (FES)

Device

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.

Conventional Therapy

Other
  • 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 outcomes

  1. gait speed by 10m walking test

    Time frame: 4 weeks

Secondary outcomes

  1. motor arm impairment by Fugl Mayer assessment

    Time frame: 4 weeks

  2. Activities of daily living by Barthel index

    Time frame: 4 weeks

  3. postural stability by Berg Balance scale

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

Multi-pad Functional Electrical Stimulation for Droop Foot Treatment

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2016
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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