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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75455247 |
| Secondary identifying numbers | 001; NTR494 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 04/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A I R Kottink-Hutten
Scientific
Scientific
Roessingh Research and Development
P.O. Box 310
Enschede
7500 AH
Netherlands
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | RCT PNS (peroneal nerve stimulation) |
| Study objectives | 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 |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Dropfoot, stroke |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Walking speed |
| Secondary outcome measures | 1. Endurance 2. Spasticity 3. EMG 4. 3D-kinematics 5. Quality of life questionnaires 6. Activity monitoring 7. Carry-over effect |
| Overall study start date | 01/09/2002 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 29 |
| Total final enrolment | 29 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Roessingh Research and Development
Enschede
7500 AH
Netherlands
7500 AH
Netherlands
Sponsor information
Roessingh Research and Development B.V. (The Netherlands)
Research organisation
Research organisation
P.O. Box 310
Enschede
7500 AH
Netherlands
| Website | http://www.rrd.nl |
|---|---|
"ROR" |
https://ror.org/01dmjt679 |
Funders
Funder type
Government
SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2007 | 04/07/2019 | Yes | No |
Editorial Notes
04/07/2019: Publication reference and total final enrolment added.
