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
Protocol serial number	N/A
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

Primary study design	Interventional
Study design	A multi-centre, single-blinded, placebo-controlled randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	(Cost)effectiveness of a mental practice based rehabilitation training in patients with an unilateral stroke: a randomised controlled trial
Study acronym	IMAGE
Study objectives	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(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) studied	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
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.
Key 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.
Completion date	01/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Key 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
Key exclusion criteria	Does not comply with the above inclusion criteria.
Date of first enrolment	01/01/2008
Date of final enrolment	01/01/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Rehabilitation Foundation Limburg

Hoensbroek
6432 CC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2013		Yes	No
Protocol article	protocol	11/04/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes