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.…
ID
Bron
Verkorte titel
Aandoening
Chronic stroke patients with a drop foot.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Walking speed.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Two-channel implantable peroneal nerve stimulator.
Publiek
Roessinghsbleekweg 33b
A.I.R. Kottink-Hutten
Roessinghsbleekweg 33b
Enschede 7522 AH
The Netherlands
+31 (0)53 4875733
a.kottink@rrd.nl
Wetenschappelijk
Roessinghsbleekweg 33b
A.I.R. Kottink-Hutten
Roessinghsbleekweg 33b
Enschede 7522 AH
The Netherlands
+31 (0)53 4875733
a.kottink@rrd.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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;
6. Pregnancy.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL454 |
NTR-old | NTR494 |
Ander register | : 001 |
ISRCTN | ISRCTN75455247 |