Multi-pad FES System for Drop Foot Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02729636|
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2016
Last Update Posted : July 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Foot Drop||Device: multi-pad functional electrical stimulation (FES) Other: Conventional therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multi-pad Functional Electrical Stimulation for Droop Foot Treatment|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||December 22, 2020|
|Estimated Study Completion Date :||December 22, 2020|
The group will be treated with multipad electrical stimulation device.
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.
Active Comparator: control
The group will be treated with conventional treatment.
Other: 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.
- gait speed by 10m walking test [ Time Frame: 4 weeks ]
- motor arm impairment by Fugl Mayer assessment [ Time Frame: 4 weeks ]
- Activities of daily living by Barthel index [ Time Frame: 4 weeks ]
- postural stability by Berg Balance scale [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729636
|Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade|
|Belgrade, Serbia, 11000|