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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30837
Enrollment
10
Registered
2007-08-07
Start date
2007-09-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CVA stroke

Interventions

Implantation and usage of an FES system to correct drop foot

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Severe cognitive deficit - Pregnancy - Depressive or psychotic disorder - Pace-maker

Design outcomes

Primary

MeasureTime frame
- obstacle avoidance success rates (in terms of failures to avoid obstacles) - net energy cost of walking at comfortable speed

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)