The effects of an implantable FES device (Actigait) on walking skills in stroke patients with a drop foot

Conditions: CVA
stroke
10007963

Registration Number: NL-OMON30837

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- chronic stroke (> 6 months post-stroke)
- drop foot
- insufficient therapeutic effects of conventional treatment methods, such as an AFO, orthopedic footwear, or discomfort with the use of these orthotic devices
- passive range of ankle motion > 30 degrees with at least 0 degrees of dorsiflexion with extended knee on physical examination
- ankle spasticity 0-3 as assessed by the Modified Ashworth Scale
- independent walking ability without walking aid for > 10 minutes
- age 18-60 years
- able to visit the academic hospitals in both Nijmegen and Amsterdam on multiple occasions during a nine-months period
- positive response to an external peroneal stimulation

Exclusion Criteria

- Severe cognitive deficit
- Pregnancy
- Depressive or psychotic disorder
- Pace-maker

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- obstacle avoidance success rates (in terms of failures to avoid obstacles)<br /><br>- net energy cost of walking at comfortable speed</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- step length, step width, step frequency, cadence<br /><br>- duration of stance, swing, and double support phase<br /><br>- range of motion of ankle, knee, and hip during walking<br /><br>- EMG onset latency and amplitude in response to the obstacle<br /><br>- spatial avoidance characteristics (horizontal and vertical toe clearance)<br /><br>- ankle and knee moments and power during the stance phase of walking<br /><br>- activity level (pedometer and questionnaire)<br /><br>- comfortable walking speed (level walking normal surface)<br /><br>- outdoor walking speed<br /><br>- personal use (questionnaire)</p><br>