The effectiveness of the Ness L-300 neuroprosthesis compared to the use of a conventional AFO or orthopaedic shoes (OSA) on walking activity of stroke patients

• Conditions: 10007963; Stroke; Cerebrovascular Accident

• Registration Number: NL-OMON31655
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

chronic stroke (> 6 months post stroke)
drop foot
regular use of a polypropylene AFO or orthopaedic shoes ('OSA')
passive range of ankle motion >30 degrees, with neutral position in stance
ankle spasticity 0-3 as assessed by the Modified Ashworth Scale
independent walking ability (with or without walking aid) > 10 minutes.
Age 18-80 years
Able to visit the rehabilitation centre on multiple occasions during a 3 month period.
Superficial and deep peroneal nerve can be stimulated as well

Exclusion Criteria

severe cognitive deficits
skin lesions at the electrode sites
pregnancy
psychological disorders (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>Walking activity measured with a StepWatch activity monitor mounted around the<br /><br>ankle during 7 days.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>functional gains, assessed with Goal Attainment Scaling<br /><br>patient satisfaction, assessed with a questionnaire<br /><br>comfortable walking speed (10 meter test) and the distance covered in 6-min<br /><br>energy cost of walking estimated from oxygen uptake (VO2) measurement<br /><br>gait parameters</p><br>