Condition category
Circulatory System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A I R Kottink-Hutten

ORCID ID

Contact details

Roessingh Research and Development
P.O. Box 310
Enschede
7500 AH
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001; NTR494

Study information

Scientific title

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 measures

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

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

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

http://www.rrd.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes