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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34481

Enrollment

Registered

2010-11-16

Start date

2011-02-15

Completion date

Unknown

Last updated

2024-05-06

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 a FES system to correct drop foot

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 18-70 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

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

Design outcomes

Primary

Measure	Time frame
Primary outcomes: - Emory Functional Ambulation Profile (E-FAP) score.	—

Secondary

Measure	Time frame
Secondary outcomes: - 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 - ankle and knee moments and power during the stance phase of walking - spatial obstacle avoidance characteristics during E-FAP obstacle sub-test (horizontal and vertical toe clearance) - obstacle avoidance success rates (in terms of failures to avoid obstacles or E-FAP obstacle sub-score) - the ratio of cMAP (as the peripheral evoked motor response) and MEP (as the centrally generated motor response) Utility measures: - both 10-m and 6-minute comfortable walking speed (level walking normal surface) - activity level (pedometer) - SIS-scores (Stroke Impact Scale) + social participation domain - PASIPD-scores (Physical Activity Scale for Individuals with Physical Disabilities) - personal use (questionnaire)	—

Measure

Time frame

Secondary outcomes: - 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 - ankle and knee moments and power during the stance phase of walking - spatial obstacle avoidance characteristics during E-FAP obstacle sub-test (horizontal and vertical toe clearance) - obstacle avoidance success rates (in terms of failures to avoid obstacles or E-FAP obstacle sub-score) - the ratio of cMAP (as the peripheral evoked motor response) and MEP (as the centrally generated motor response) Utility measures: - both 10-m and 6-minute comfortable walking speed (level walking normal surface) - activity level (pedometer) - SIS-scores (Stroke Impact Scale) + social participation domain - PASIPD-scores (Physical Activity Scale for Individuals with Physical Disabilities) - personal use (questionnaire)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)