Contact information
Type
Scientific
Primary contact
Dr Jeanine Verbunt
ORCID ID
Contact details
Rehabilitation Foundation Limburg
Zandbergsweg 111
Hoensbroek
6432 CC
Netherlands
+31 (0)45 528 2226
j.verbunt@srl.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
(Cost)effectiveness of a mental practice based rehabilitation training in patients with an unilateral stroke: a randomised controlled trial
Acronym
IMAGE
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke/neurorehabilitation
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/01/2008
Overall trial end date
01/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
Does not comply with the above inclusion criteria.
Recruitment start date
01/01/2008
Recruitment end date
01/01/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Rehabilitation Foundation Limburg
Hoensbroek
6432 CC
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Sponsor details
P.O. Box 93245
Den Haag
2509 AE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18405377
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23273853
Publication citations
-
Protocol
Verbunt JA, Seelen HA, Ramos FP, Michielsen BH, Wetzelaer WL, Moennekens M, Mental practice-based rehabilitation training to improve arm function and daily activity performance in stroke patients: a randomized clinical trial., BMC Neurol, 2008, 8, 7, doi: 10.1186/1471-2377-8-7.
-
Results
Timmermans AA, Verbunt JA, van Woerden R, Moennekens M, Pernot DH, Seelen HA, Effect of mental practice on the improvement of function and daily activity performance of the upper extremity in patients with subacute stroke: a randomized clinical trial., J Am Med Dir Assoc, 2013, 14, 3, 204-212, doi: 10.1016/j.jamda.2012.10.010.