Multi-pad Functional Electrical Stimulation for Droop Foot Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Belgrade
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- gait speed by 10m walking test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
gait speed by 10m walking test
Time Frame: 4 weeks
Secondary Outcomes
- postural stability by Berg Balance scale(4 weeks)
- motor arm impairment by Fugl Mayer assessment(4 weeks)
- Activities of daily living by Barthel index(4 weeks)
Investigators
Konstantinovic Ljubica
professor
University of Belgrade