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17 May 2008
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| [ Print-friendly version ] |
| TEchnology-Supported Task-oriented TRaining of Arm-hand function in persons with Chronic Stroke |
| ISRCTN | ISRCTN82787126 |
| ClinicalTrials.gov identifier | |
| Public title | TEchnology-Supported Task-oriented TRaining of Arm-hand function in persons with Chronic Stroke |
| Scientific title | |
| Acronym | TEST-TRACS |
| Serial number at source | N/A |
| Study hypothesis | An 8-week technology-supported task-oriented training program improves skilled arm-hand performance and quality of life in chronic stroke patients. This improvement is larger after technology supported task-oriented training than after task-oriented training without technology support. Differences in improvement of skilled arm-hand performance between training conditions will last for at least 6 months. |
| Ethics approval | Submitted to the Medical Ethics Committee of Rehabilitation Foundation Limburg (Stichting Revalidatie Limburg), Hoensbroek, the Netherlands. Approval pending as of 11/04/2008. |
| Study design | Multi-centre, single-blind, randomised controlled trial. |
| Countries of recruitment | The Netherlands |
| Disease/condition/study domain | Stroke/ Neurorehabilitation |
| Participants - inclusion criteria |
1. First ever stroke
2. 18-85 years old, male and female 3. Clinically diagnosed as having a central paresis of the arm/hand (strength: Medical Research Council grade 2-3-4 at entry into the study) 4. Post-stroke time >= 12 months 5. Fair-good cognitive level (Mini Mental State Examination [MMSE] score >= 26 or CogLog score >= 26) 6. Ability to read and understand Dutch language 7. Impaired as to at least two of the following skills: drinking from a cup, eating with knife and fork, open/close clothing, taking money from purse, wash/dry body, holding reek/broom/spade, grooming, keyboard work, balancing object while holding it 8. Motivated to train on above mentioned skills |
| Participants - exclusion criteria |
1. Neglect: Bells Test, Letter Cancellation Test: minimum omission score of 15% is considered to indicate unilateral spatial neglect
2. Hemianopsia, retrieved from patient's medical file 3. Severe spasticity: Modified Ashworth Scale total arm >4 4. Severe additional neurological, orthopaedic or rheumatoid impairments prior to stroke that may interfere with task performance 5. Broca aphasia, Wernicke aphasia, global aphasia: as determined by the Akense Afasie Test 6. Apraxia: Apraxietest of Van Heugten |
| Anticipated start date | 01/09/2008 |
| Anticipated end date | 30/06/2010 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 |
| Interventions |
Intervention group:
Participants train on at least two skills they select from a list of 10 skills established in prior research. Participants will receive video-based instruction of predefined task-oriented exercises required for the training. Exercises are offered with increasing difficulty levels for skill components that keep a strong relation with the skill itself. Task-oriented training will be supported by technology, i.e. upper limb kinematics will be recorded during skill performance in stroke patients while training. Feedback about exercise performance (knowledge of performance and knowledge of results) is given both during and after exercise, based on registration of kinematic parameter information. Patients train for 8 weeks at a minimum of 4 days per week, 30 minutes twice per day. Control group: Participants train on at least two skills from a list of 10 skills on offer. Participants will receive video-based instruction of predefined task-oriented training exercises required. Exercises are offered with increasing difficulty levels for skill components that keep a strong relation with the skill itself. Patients train for 8 weeks at a minimum of 4 days per week, 30 minutes twice per day. The control group will perform training without technology support or technology-based feedback on performance. |
| Primary outcome measure(s) |
Arm-hand function:
1. As measured on function level by Brunnstrom-Fugl-Meyer Test 2. As measured on activity level by the Action Research Arm Test and the Motor Activity Log The outcomes above will be assessed at the following timepoints: T0: Baseline T1: After training for 4 weeks T2: After training for 8 weeks T3: 6 months after finishing the training programme |
| Secondary outcome measure(s) |
Quality of life at T0, T2 and T3:
1. The 36-item Short Form health survey (SF-36) 2. EuroQol-6D questionnaire T0: Baseline T1: After training for 4 weeks T2: After training for 8 weeks T3: 6 months after finishing the training programme |
| Sources of funding |
1. Philips Research (The Netherlands)
2. Technical University Eindhoven (The Netherlands) 3. Rehabilitation Foundation Limburg (Stichting Revalidatie Limburg [SRL]) (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Mrs Annick Timmermans |
| Address | Zandbergsweg 111 |
| City/town | Hoensbroek |
| Zip/Postcode | 6432 CC |
| Country | Netherlands |
| Tel | +31 45 5282372 |
| Fax | +31 45 5282227 |
| A.Timmermans@tue.nl | |
| Sponsor | Rehabilitation Foundation Limburg (Stichting Revalidatie Limburg [SRL]) (The Netherlands) |
| Address |
c/o Dr Henk Seelen
Zandbergsweg 111 |
| City/town | Hoensbroek |
| Zip/Postcode | 6432 CC |
| Country | Netherlands |
| Sponsor website: | http://www.srl.nl |
| Date applied | 11/04/2008 |
| Last edited | 17/04/2008 |
| Date ISRCTN assigned | 17/04/2008 |
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