|- candidate number||10739|
|- NTR Number||NTR3210|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-dec-2011|
|- Secondary IDs||07.21 Dutch Heart Foundation (Hartstichting)|
|- Public Title||Recovery of walking ability using a robotic device.|
|- Scientific Title||Recovery of walking ability using a robotic device.|
|- hypothesis||The general hypothesis of the study is that robot-assisted treadmill training with will lead to greater improvements of functional outcome measures of gait performance, social participation and quality of life in stroke patients than the regular care.|
|- Healt Condition(s) or Problem(s) studied||Stroke, Walking competency, Recovery|
|- Inclusion criteria||1. Minimum age of 18 yrs;|
2. Hemiparesis (at least of lower limb) as a result of a first ever stroke;
3. Patients must be incapable to walk unaided.
Subjects who are inpatients of the Rehabilitation Centre will start with the training as soon as they would normally start with the rehabilitation program.
|- Exclusion criteria||1. Medical complications such as unstable hypertension, arrhythmias and unstable cardiovascular problems;|
2. Severe skeletal problems such as osteoarthritis of the lower limbs;
3. Severe cognitive and/or communicative problems, preventing ability to follow verbal instructions;
4. Earlier neurological and/or psychiatric problems; other problems that would limit the ability to perform the requested tasks;
5. Contra-indications for electrical stimulation (unstable epilepsy, cancer, skin abnormalities, pacemaker).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2008|
|- planned closingdate||1-mrt-2012|
|- Target number of participants||80|
|- Interventions||8 weeks: 3.5 hours/week, duration matched.
Robot assisted training group: Robot asssited treadmill training using the Lokomat combined with convention physical therapy.
Control group: Conventional physical therapy.
|- Primary outcome||Walking speed, measured with the 10-m walking speed test.|
|- Secondary outcome||1. Balance/independency of walking;|
2. Quality of life;
3. Muscle strength.
Tests used are:
1. Functional Ambulation Category;
2. Timed up-and-go;
3. Berg Balance Scale;
4. Rivermead Mobility Index;
5. Fugl-Meyer Assessment;
6. Motricity Index;
7. Stroke Impact Scale;
8. Short Form 36;
9. Sickness Impact Profile 68.
|- Timepoints||1. Pre-intervention (wk 1);|
2. Post-intervention (wk 10);
3. 24 wks. after start intervention (wk 24);
4. 36 wks. after start intervention (wk 36).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Michiel Nunen, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Karin Gerrits|
|- Sponsor/Initiator ||Vrije Universiteit Amsterdam|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary||The primary objective of the study was to investigate the effectiveness of Locomat training on locomotor performance, participation and quality of life. The study consisted of a randomised clinical trial for stroke patients and further aimed to assess the time course of effects, not only during the training period, but also during follow-up after cessation of the training. Patients, aged from 18 yrs, with left or right hemiparesis as a result of first ever-stroke who were incapable of walking unsupervised were assigned to either a control group or an experimental group. All patients (experimental as well as control) received similar standard occupational and physical therapy care, except for the gait training module which is part of the rehabilitation program. The experimental group received a specific (gait) training program consisting of 2 weekly (1 hour per training) robot-assisted treadmill training sessions with a Lokomat robotic gait orthosis aimed at increasing duration of walking in the device to 45 minutes per session, whereas the control group received conventional physical therapy. Outcome measures for functional ability were walking speed, time to perform "get-up-and-go" test; score at Berg Balance Scale; Functional Ambulation Categories-score; Rivermead Mobility Index; and Brunnstrom Fugl-Meyer. Scores at the questionnaires SIS and SF-36 were used for assessment of quality of life and scores at the SIP-68 were used for assessment of social participation. Study parameters were assessed at baseline, after intervention (8 weeks), after 24 weeks and after 36 weeks.|
|- Main changes (audit trail)|
|- RECORD||21-dec-2011 - 15-jan-2012|