The effect of the implantable two-channel peroneal nerve stimulator as a treatment in stroke patients with a drop foot in comparison with the conventional treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28906

Enrollment

Registered

2005-09-28

Start date

2002-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Chronic stroke patients with a drop foot.

Interventions

Two-channel implantable peroneal nerve stimulator.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Dropped foot identified by an inability to achieve a normal heel strike during walking; 2. First hemiplegia of at least 6 months as a result of a CVA with a stable neurology; 3. Successful functional recovery after surface stimulation of the common peroneal nerve; 4. Subject is an outdoor walker; 5. Able to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Age < 18 year; 2. Passive dorsiflexion of the ankle <5º with knee in extension; 3. Medical conditions limiting the function of walking other than CVA, i.e. neurological, rheumatic, cardio-vascular or systemic disorders (including Diabetes Mellitus); 4. Injury of n.peroneus or n.ischiadicus; 5. Not be able to don and doff the equipment; 6. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Walking speed.	—

Secondary

Measure	Time frame
1. Endurance; 2. Spasticity; 3. EMG; 4. 3D-kinematics; 5. Quality of life questionnaires; 6. Activity monitoring; 7. Carry-over effect.	—

Contacts

Public ContactA.I.R. Kottink-Hutten

Roessingh Research and Development, Roessinghsbleekweg 33b

a.kottink@rrd.nl+31 (0)53 4875733

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)