Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Konstantinovic Ljubica, University of Belgrade

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Foot Drop Device: multi-pad functional electrical stimulation (FES) Other: Conventional therapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: FES:a
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. gait speed by 10m walking test [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Serbia
Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Konstantinovic Ljubica, professor, University of Belgrade
ClinicalTrials.gov Identifier: NCT02729636    
Other Study ID Numbers: LK-4
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peroneal Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases