|- candidate number||1736|
|- NTR Number||NTR494|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||28-sep-2005|
|- Secondary IDs||001 |
|- 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||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).|
|- hypothesis||The 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 ROM;
7. reduced disability.
|- Healt Condition(s) or Problem(s) studied||Stroke, Drop foot|
|- 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||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;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2002|
|- planned closingdate||31-dec-2005|
|- Target number of participants||29|
|- Interventions||Two-channel implantable peroneal nerve stimulator.|
|- Primary outcome||Walking speed.|
|- Secondary outcome||1. Endurance; |
5. Quality of life questionnaires;
6. Activity monitoring;
7. Carry-over effect.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.I.R. Kottink-Hutten|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.I.R. Kottink-Hutten|
|- Sponsor/Initiator ||Roessingh Research and Development b.v.|
(Source(s) of Monetary or Material Support)
|- Brief summary||Dropped foot is a condition found in several patient groups, including Multiple Sclerose, incomplete spinal cord injury and most notably, stroke. |
Stroke is one of the most common disorders affecting the neuromuscular system.
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, FES systems for the treatment of dropped foot are in clinical use in significant numbers.
Functional Electrical Stimulation (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 implantable stimulator in comparison with the conventional treatment will be examined by measuring different parameters.
|- Main changes (audit trail)|
|- RECORD||28-sep-2005 - 9-okt-2008|