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| [ ...Back to search results ] | [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN75455247 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | RCT PNS (peroneal nerve stimulation) |
| Serial number at source | 001; NTR494 |
| Study hypothesis |
The functional electrical stimulation (FES) group will show in comparison with the conventional therapy group:
1. Increased gait speed (primary outcome) 2. Increased endurance 3. Improved gait kinematics 4. Increased muscle activity level 5. Reduced spasticity 6. Positive effect on passive range of movement (ROM) 7. Reduced disability |
| Lay summary | |
| Ethics approval | Received from the local medical ethics committee |
| Study design | Randomised, active controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Dropfoot, stroke |
| Participants - 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 cerebrovascular accident (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 |
| Participants - exclusion criteria |
1. Aged less than 18 years
2. Passive dorsiflexion of the ankle less than 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 |
| Anticipated start date | 01/09/2002 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 29 |
| Interventions |
The conventional management of dropped foot has been to use a rigid orthosis to maintain the ankle in a neutral position. This has major limitations as a treatment, being both uncomfortable and awkward to use and hence is often rejected by patients and therapists.
Currently, functional electrical stimulation (FES) systems for the treatment of dropped foot are in clinical use in significant numbers. FES is the artificial stimulation of muscles with the purpose of evoking a motor response. Compared with the use of orthosis, electrical stimulation has a number of advantages: it prevents muscle atrophy, the blood flow remains normal or even improves and it is cosmetically better accepted. An implantable system was developed that stimulates the two branches of the peroneal nerve separately. Results from previous studies indicate that the system is safe to use, well liked by the patients, provides selectivity over moments at the ankle joint and increases both walking speed and endurance. In the present study the additional value of the two-channel implantable peroneal nerve stimulator in comparison with the conventional treatment will be examined by measuring different parameters. |
| Primary outcome measure(s) | Walking speed |
| Secondary outcome measure(s) |
1. Endurance
2. Spasticity 3. EMG 4. 3D-kinematics 5. Quality of life questionnaires 6. Activity monitoring 7. Carry-over effect |
| Sources of funding | SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr A I R Kottink-Hutten |
| Address |
Roessingh Research and Development
P.O. Box 310 |
| City/town | Enschede |
| Zip/Postcode | 7500 AH |
| Country | Netherlands |
| Sponsor | Roessingh Research and Development B.V. (The Netherlands) |
| Address | P.O. Box 310 |
| City/town | Enschede |
| Zip/Postcode | 7500 AH |
| Country | Netherlands |
| Sponsor website: | http://www.rrd.nl |
| Date applied | 27/01/2006 |
| Last edited | 03/11/2008 |
| Date ISRCTN assigned | 27/01/2006 |
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