Mental practice based rehabilitation training aimed at improving arm function and performance of daily activities in stroke: a randomised clinical trial

ISRCTN ISRCTN33487341
DOI https://doi.org/10.1186/ISRCTN33487341
Secondary identifying numbers N/A
Submission date
07/12/2007
Registration date
14/01/2008
Last edited
06/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeanine Verbunt
Scientific

Rehabilitation Foundation Limburg
Zandbergsweg 111
Hoensbroek
6432 CC
Netherlands

Phone +31 (0)45 528 2226
Email j.verbunt@srl.nl

Study information

Study designA multi-centre, single-blinded, placebo-controlled randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title(Cost)effectiveness of a mental practice based rehabilitation training in patients with an unilateral stroke: a randomised controlled trial
Study acronymIMAGE
Study objectivesA 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.
Ethics approval(s)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).
Health condition(s) or problem(s) studiedStroke/neurorehabilitation
InterventionIntervention:
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.
Intervention typeOther
Primary outcome measureUpper 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 measuresUpper 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.
Overall study start date01/01/2008
Completion date01/01/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants160
Key inclusion criteria1. 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
Key exclusion criteriaDoes not comply with the above inclusion criteria.
Date of first enrolment01/01/2008
Date of final enrolment01/01/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Rehabilitation Foundation Limburg
Hoensbroek
6432 CC
Netherlands

Sponsor information

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation

P.O. Box 93245
Den Haag
2509 AE
Netherlands

Website http://www.zonmw.nl
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/04/2008 Yes No
Results article results 01/03/2013 Yes No