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ISRCTN
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ISRCTN33487341
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ClinicalTrials.gov identifier
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Public title
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Mental practice based rehabilitation training aimed at improving arm function and performance of daily activities in stroke: a randomised clinical trial
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Scientific title
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(Cost)effectiveness of a mental practice based rehabilitation training in patients with an unilateral stroke: a randomised controlled trial
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Acronym
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IMAGE
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Serial number at source
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N\A
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Study hypothesis
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A mental practice based rehabilitation training aimed at the improvement of arm hand function in patients with upper extremity paresis in the sub-acute phase of stroke is (cost)effective in improving arm function and the performance of daily activities as compared to therapy as usual.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics approval received from the medical ethical board of SRL METC (Rehabilitation Foundation Limburg Medical Board) on the 21st February 2008 (ref: METC-08-0001).
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Study design
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A multi-centre, single-blinded, placebo-controlled randomised trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Stroke/neurorehabilitation
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Participants - inclusion criteria
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1. First ever stroke
2. Post-stroke time of 2 - 6 weeks
3. Clinically diagnosed central paresis of the arm/hand with strength Medical Research Council (MRC) grade 1 to 3 of the elbow flexors at entry into the study
4. Age between 18 and 85 years, male and female
5. Fair cognitive level (Mini Mental State Examination [MMSE] score above 23)
6. No severe additional neurological, orthopaedic, rheumatoid or cardiac impairments prior to stroke
7. No severely impaired communication as to comprehension
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Participants - exclusion criteria
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Does not comply with the above inclusion criteria.
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Anticipated start date
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01/01/2008
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Anticipated end date
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01/01/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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160
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Interventions
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Intervention:
Mental practice training: training programme three times a day (10 - 15 minutes) during 10 weeks in additional to therapy as usual. The training is guided by CD-rom. Different training tasks are available depending on the functional level of the patient. Patients can practice at home, in the hospital or in a rehabilitation centre. A occupational therapist will coach during the programme.
Control group:
Patients will be instructed to practice additional bimanual upper extremity techniques based on conservative neurodevelopmental (NDT) principles. Training intensity is three times a day during 10 weeks.
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Primary outcome measure(s)
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Upper extremity functioning assessed on activity level:
1. Wolf Motor Function test
2. Motor Activity Log
Both primary and secondary outcome measures will be assessed at baseline, after 10 weeks and 6 and 12 months.
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Secondary outcome measure(s)
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Upper extremity functioning assessed on impairment and participation level:
1. Impairment: Brunnstrom-Fugl-Meyer test
2. Participation:
2.1. Impact on Participation and Autonomy questionnaire
2.2. Quality of life: EuroQol (EQ-6D)
Both primary and secondary outcome measures will be assessed at baseline, after 10 weeks and 6 and 12 months.
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18405377
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Contact name
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Dr
Jeanine
Verbunt
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Address
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Rehabilitation Foundation Limburg
Zandbergsweg 111
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City/town
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Hoensbroek
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Zip/Postcode
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6432 CC
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Country
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Netherlands
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Tel
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+31 (0)45 528 2226
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Fax
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+31 (0)45 528 2000
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Email
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j.verbunt@srl.nl
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Sponsor
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Address
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P.O. Box 93245
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City/town
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Den Haag
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Sponsor website:
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http://www.zonmw.nl
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Date applied
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07/12/2007
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Last edited
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07/09/2011
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Date ISRCTN assigned
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14/01/2008
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