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Arm support treatment in the early phase after stroke.


- candidate number8508
- NTR NumberNTR2539
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2010
- Secondary IDsNL33365.044.10 CCMO
- Public TitleArm support treatment in the early phase after stroke.
- Scientific TitleArm support treatment in the early phase after stroke.
- ACRONYMEarlyArmSupport
- hypothesisPatients who are treated with the ArmeoBoom will have similar or improved arm function in comparison with the patients who receive conventional arm therapy. In case the improvement is similar, the therapy must be more efficient for a therapist (possibility to train two patients on the same time) to make the study succesfull.
- Healt Condition(s) or Problem(s) studiedStroke, Stroke
- Inclusion criteria1. Start of participation between 1 and 12 weeks post first-ever stroke;
2. Hemiparetic arm, with ability of some elbow extension (MRC score 2 or 3 out of 5);
3. Ability to understand and follow instructions;
4. Ability to endure training and evaluation sessions.
- Exclusion criteriaCo-morbidity of other diseases (incl. pain) that limit use of the arm.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2010
- planned closingdate31-mei-2012
- Target number of participants70
- InterventionsThe participants receive reach training for the affected arm during 6 weeks, 3 times 30 minutes per week. The intervention group (35 persons) will train using the ArmeoBoom system for arm support and the control group (35 persons) will perform standardized reaching exercises, with similar training intensity.
- Primary outcomeBefore and after training changes in overall arm function (Fugl-Meyer assessment, Stroke Upper Limb Capacity Scale) and work area are quantified.
- Secondary outcomeUser experience of therapist and patient (semi-structured interviews) are identified after training. Both before and after training a Visual Analog Scale for pain is filled in by patients.
- TimepointsAt baseline and within a week after the training period of 6 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.I.R. Kottink-Hutten
- CONTACT for SCIENTIFIC QUERIESDrs. A.I.R. Kottink-Hutten
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
Revalidatie Nederland
- PublicationsPrange, GB. Rehabilitation Robotics - Stimulating restoration of arm function after stroke (dissertation). Enschede, University of Twente, 2009. ISBN 978-90-365-2901-3.
- Brief summaryAfter a stroke, many patients suffer from an impaired motor task performance of the upper extremity. Optimal restoration of arm and hand function is important for stroke patients to independently perform activities of daily living. To stimulate restoration of arm function after stroke, intensive and task-specific training is essential. To implement this, the application of robotic devices in rehabilitation is promising. Especially, active movements may be facilitated by the application of arm support. One of the biggest advantages of arm support using a robotic device is currently the possibility to 'automate' treatment (a therapist can treat multiple patients simultaneously) so that the productivity of health care can be increased and the costs can be reduced. Contemporary research on this has focused on patients in the chronic phase after stroke. However, it is likely that especially patients in the sub-acute phase after stroke benefit from this application, since recovery processes can be stimulated directly.The purpose of this study is to compare the effect of arm support therapy with conventional therapy, directed at arm function in stroke patients in the sub-acute phase, with regard to both motor aspects and user experiences.Multicenter, randomized intervention study with evaluation measurements before and after 6 weeks of reach training. 70 stroke patients in the sub-acute phase (between 1 and 12 weeks post-stroke) from 7 Dutch rehabilitation centers (10 patients per center): Revalidatiecentrum Het Roessingh (Enschede), Sint Maartenskliniek (Nijmegen), De Hoogstraat (Utrecht), Beatrixoord (Haren), Groot Klimmendaal (Arnhem), Rijndam (Rotterdam) en Revalidatie Centrum Amsterdam. Participants are able to lift the arm (partially) and to perform reach-like movements.The participants receive reach training for the affected arm during 6 weeks, 3 times 30 minutes per week. The intervention group (35 persons) will train using the ArmeoBoom system for arm support and the control group (35 persons) will perform standardized reaching exercises, with similar training intensity.Before and after training changes in overall arm function (Fugl-Meyer assessment, Stroke Upper Limb Capacity Scale) and work area are quantified.Also, user experience of therapist and patient (semi-structured interviews) are identified after training. Both before and after training a Visual Analog Scale for pain is filled in by patients.
- Main changes (audit trail)
- RECORD29-sep-2010 - 11-apr-2011


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