Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-10-22
2021-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FES:a
The group will be treated with multipad electrical stimulation device.
multi-pad functional electrical stimulation (FES)
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.
control
The group will be treated with conventional treatment.
Conventional therapy
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.
Interventions
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multi-pad functional electrical stimulation (FES)
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
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
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Inclusion Criteria
* 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
* 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).
ALL
No
Sponsors
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University of Belgrade
OTHER
Responsible Party
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Konstantinovic Ljubica
professor
Locations
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Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, , Serbia
Countries
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References
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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.
Other Identifiers
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LK-4
Identifier Type: -
Identifier Source: org_study_id