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Effect of functional electrical stimulation of the ankle dorsiflexor muscles on the recovery of walking ability in patients with sub/postacute stroke.


- candidate number14459
- NTR NumberNTR3879
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mrt-2013
- Secondary IDsMEC-2012-021 METC Erasmus MC
- Public TitleEffect of functional electrical stimulation of the ankle dorsiflexor muscles on the recovery of walking ability in patients with sub/postacute stroke.
- Scientific TitleEffect of functional electrical stimulation of the ankle dorsiflexor muscles on the recovery of walking ability in patients with sub/postacute stroke.
- ACRONYMFES-CVA
- hypothesisThere is no difference in het use of Functional electrical stimulation compared to the use of an ankle foot orthosis in the subacute / post-acute phase after stroke on the recovery of walking ability.
- Healt Condition(s) or Problem(s) studiedStroke, Functional electrical stimulation, Gait
- Inclusion criteria1. Patients with a first stroke;
2. Subacute phase after stroke (between 4 weeks and 6 months after onset);
3. Age between 18-70 years;
4. Ischemic or hemorrhagic stroke;
5. Hemiparesis;
6. The passive range of motion of the dorsiflexor muscle of the ankle on the hemiparetic side is minimal 5 degrees;
7. Functional ambulation scale score 3.
- Exclusion criteria1. Cardiac or pulmonary disease that creates a contraindication for physical training;
2. On-demand pacemaker, defibrillator or any electrical or metal implant that could be influenced by the electrostimulation;
3. Malignant tumors;
4. Presence of a fracture or dislocation in the affected leg.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2012
- planned closingdate1-aug-2013
- Target number of participants30
- InterventionsParticipants are randomised to sessions of 30 minutes a day, 5 days a week, for 4 weeks of physiotherapy using either the FES walking aid or the AFO.
- Primary outcome1. 10m Walk Test (10MLT);
2. 6 minutes walk test (6MWT).
- Secondary outcome1. Berg Balance Scale (BBS);
2. Motricity Index of the lower extremities (MI);
3. Modified Ashworth Scale (MAS);
4. Functional Ambulation Categories (FAC);
5. Ankle movement; the maximum dorsiflexion of the ankle.
- TimepointsThe participants were evaluated before and immediately after the training program.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M. Kortsmit
- CONTACT for SCIENTIFIC QUERIESDrs. M. Kortsmit
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Libra zorggroep (rehabilitation center) Eindhoven, Tilburg The netherlands
- PublicationsN/A
- Brief summaryThis study is to identify the effects of a functional elektrical peroneal stimulation (FES) compared to ankle foot orthosis (AFO) on the recovery of walking ability in stroke patients with hemiparesis in the sub/ post-acute phase?
- Main changes (audit trail)
- RECORD4-mrt-2013 - 11-mrt-2013


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