|- candidate number||6157|
|- NTR Number||NTR1930|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jul-2009|
|- Secondary IDs||NL28347.044.09 METC MST Enschede|
|- Public Title||Timing of providing ankle-foot orthoses in stroke rehabilitation.|
|- Scientific Title||Timing of providing ankle-foot orthoses in stroke rehabilitation. |
|- hypothesis||Early provision of AFOs (± 2 wks after stroke) is expected to positively affect walking impairments, mobility and activities of daily living after acute stroke compared to providing AFOs later on in the rehabilitation process (± 10 wks after stroke). Furthermore, early provision of AFOs is expected to positively affect falling and quality of life.|
|- Healt Condition(s) or Problem(s) studied||Stroke, Quality of life, Rehabilitation, Mobility, Falling, Ankle-foot orthoses|
|- Inclusion criteria||1. Admission into the Roessingh Rehabilitation Centre, Enschede;|
2. Single and first ever unilateral ischaemic or haemorrhagic hemiparetic stroke;
3. Time since stroke max 3 weeks;
4. Age 18 years or older;
5. Indication to use an AFO during rehabilitation because of: problems with stability in stance; problems with footclearance during swing; problems with foot prepositioning in early stance;
6. No severe deficits in communication;
7. No severe deficits in memory and understanding.
|- Exclusion criteria||1. Medical history of previous stroke(s);|
2. Complicating medical history such as cardiac, pulmonary, or orthopaedic disorders that could affect performance of the included measurements;
3. Severely impaired sensation;
4. Suffering from severe neglect;
5. Suffering from comprehensive aphasia.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||50|
|- Interventions||Timing of providing an ankle-foot orthosis during the rehabilitation after stroke. |
Early provision of AFOs (± 2 weeks after stroke) will be compared with providing an AFO 8 weeks later.
|- Primary outcome||Clinical tests:|
1. 10m walking test;
2. 6min walking test;
3. Functional Ambulation Categories;
4. Timed Up&Go test;
6. Rivermead Mobility Index;
7. Berg Balance Scale;
8. Barthel Index;
9. Nottingham extended ADL index.
|- Secondary outcome||1. Gait analysis (ground reaction force, joint angles, temporal and spatial parameters, muscle activity lower limb muscles);|
2. Clinical tests:
A. Motricity Index;
B. Modified Ashworth Scale;
C. Brunnstrom Fugl Meyer (leg portion);
D. Passive ankle angles.
3. Falling and QoL:
A. Falls Efficacy Scale;
B. Questionnaire (occurence of falls and all fall related events);
C. Stroke Impact Scale;
D. Subject opinion about AFO treatment (questionnaire).
|- Timepoints||1. Gait analysis: in week 1, 9, 17, 26 and 52;|
2. Clinical tests: during the first 18 weeks of the study: 2-week interval, and in week 26 and 52.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Corien Nikamp|
|- CONTACT for SCIENTIFIC QUERIES|| Corien Nikamp|
|- Sponsor/Initiator ||Roessingh Research and Development|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Welfare and Sports (VWS)|
|- Brief summary||Background: |
Ankle-foot orthoses (AFOs) are often used in the rehabilitation after stroke. The effects of AFOs are mainly studied performing cross-over studies to assess the immediate and short-term effects. Evidence for long-term effects, and especially research studying the timing of providing AFOs is lacking. In order to study the effects of timing of providing AFOs after stroke a new longitudinal research is proposed. In this explorative study acute stroke patients will be included and 2 intervention groups will be arranged. Both intervention groups will differ in the moment in which the AFO will be provided during the rehabilitation process.
To study the effects of timing of providing AFOs on mobility related activities and activities of daily living in acute stroke patients in a rehabilitation setting. Secondary, the effects of timing of providing AFOs on walking impairments, occurrence of falls and fall related events and the effect on quality of life is studied.
Longitudinal design with randomisation for the intervention, parallel groups.
Acute stroke patients admitted into the Roessingh Rehabilitation Centre in Enschede will participate. Subjects with an indication to use an AFO because of problems with stability in stance, problems with footclearance during swing or problems with foot prepositioning in early stance will be included.
Timing of providing AFOs will be compared in 2 groups:
1. Providing an AFO within one week after admission into the rehabilitation centre (approximately 2 weeks after stroke);
2. Providing an AFO 8 weeks later.
Main study parameters/endpoints:
Mobility related activities and activities of daily living (clinical tests, questionnaires). Secondary study parameters are walking impairments (gait analysis, instrumented tests, clinical tests), occurrence of falls and fall related events and quality of life after stroke (questionnaires).
|- Main changes (audit trail)|
|- RECORD||27-jul-2009 - 28-okt-2015|