The long-term effects of an implanted drop foot stimulator (ActiGait®) on walking capacity in patients with stroke

Phase 2

Recruiting

• Conditions: CVA; Stroke; 10007963

• Registration Number: NL-OMON34481
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 8

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 18-70 years
- able to visit the academic hospital in Nijmegen on multiple occasions during a 15-months period
- positive response to an external FES system

Exclusion Criteria

- severe cognitive deficits
- pregnancy
- psychological disorders (e.g. depression or psychosis)
- participation in other investigation in the prior 6 months that may affect the study results
- demand-type pacemaker

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes:<br /><br>- Emory Functional Ambulation Profile (E-FAP) score.</p><br>