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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
ISRCTN ISRCTN33487341
DOI 10.1186/ISRCTN33487341
ClinicalTrials.gov identifier
EudraCT number
Public title Mental practice based rehabilitation training aimed at improving arm function and performance of daily activities in stroke: a randomised clinical trial
Scientific title (Cost)effectiveness of a mental practice based rehabilitation training in patients with an unilateral stroke: a randomised controlled trial
Acronym IMAGE
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval 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).
Study design A multi-centre, single-blinded, placebo-controlled randomised trial
Countries of recruitment Netherlands
Disease/condition/study domain Stroke/neurorehabilitation
Participants - inclusion criteria 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
Participants - exclusion criteria Does not comply with the above inclusion criteria.
Anticipated start date 01/01/2008
Anticipated end date 01/01/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 160
Interventions 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.
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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.
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18405377
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23273853
Contact name Dr  Jeanine  Verbunt
  Address Rehabilitation Foundation Limburg
Zandbergsweg 111
  City/town Hoensbroek
  Zip/Postcode 6432 CC
  Country Netherlands
  Tel +31 (0)45 528 2226
  Fax +31 (0)45 528 2000
  Email j.verbunt@srl.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
  Address P.O. Box 93245
  City/town Den Haag
  Zip/Postcode 2509 AE
  Country Netherlands
  Sponsor website: http://www.zonmw.nl
Date applied 07/12/2007
Last edited 06/11/2013
Date ISRCTN assigned 14/01/2008
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