Multi-pad FES System for Drop Foot Treatment
Multi-pad Functional Electrical Stimulation for Droop Foot Treatment
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2021
CompletedNovember 16, 2021
November 1, 2021
3.1 years
March 29, 2016
November 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
gait speed by 10m walking test
4 weeks
Secondary Outcomes (3)
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
Study Arms (2)
FES:a
EXPERIMENTALThe group will be treated with multipad electrical stimulation device.
control
ACTIVE COMPARATORThe group will be treated with conventional treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, 11000, Serbia
Related Publications (1)
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.
PMID: 28673311DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 29, 2016
First Posted
April 6, 2016
Study Start
October 22, 2018
Primary Completion
November 10, 2021
Study Completion
November 10, 2021
Last Updated
November 16, 2021
Record last verified: 2021-11