Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001; NTR494
Study information
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
Acronym
RCT PNS (peroneal nerve stimulation)
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
Ethics approval
Received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/09/2002
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
29
Total final enrolment
29
Participant 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
Recruitment start date
01/09/2002
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Roessingh Research and Development
Enschede
7500 AH
Netherlands
Sponsor information
Organisation
Roessingh Research and Development B.V. (The Netherlands)
Sponsor details
P.O. Box 310
Enschede
7500 AH
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
SENTER - A branch of the Dutch Ministry of Economic Affairs (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17678657 (added 04/07/2019)