|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
22 November 2021 |
|
Main ID: |
NCT02729636 |
|
Date of registration:
|
29/03/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Multi-pad FES System for Drop Foot Treatment
|
|
Scientific title:
|
Multi-pad Functional Electrical Stimulation for Droop Foot Treatment |
|
Date of first enrolment:
|
October 22, 2018 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02729636 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Serbia
| | | | | | | |
|
Key inclusion & exclusion 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).
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Foot Drop
|
|
Intervention(s)
|
|
Device: multi-pad functional electrical stimulation (FES)
|
|
Other: Conventional therapy
|
|
Primary Outcome(s)
|
|
gait speed by 10m walking test
[Time Frame: 4 weeks]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|