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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

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 - L-300 peroneal nerve stimulation in stroke patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31655
Enrollment
24
Registered
2007-02-05
Start date
2007-01-15
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

Cerebrovascular Accident Stroke

Interventions

Use of peroneal stimulator Ness type L300 during 9 weeks. This device has a good fit ('one size fits all' principle) with constant positioning of 2 independent active electrodes. It has a very robus

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Walking activity measured with a StepWatch activity monitor mounted around the ankle during 7 days.

Secondary

MeasureTime frame
functional gains, assessed with Goal Attainment Scaling patient satisfaction, assessed with a questionnaire comfortable walking speed (10 meter test) and the distance covered in 6-min energy cost of walking estimated from oxygen uptake (VO2) measurement gait parameters

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)