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
Scientific
Rehabilitation Foundation Limburg
Zandbergsweg 111
Hoensbroek
6432 CC
Netherlands
| Phone | +31 (0)45 528 2226 |
|---|---|
| j.verbunt@srl.nl |
Study information
| Study design | A multi-centre, single-blinded, placebo-controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 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 | 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 study start date | 01/01/2008 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
6432 CC
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
P.O. Box 93245
Den Haag
2509 AE
Netherlands
| Website | http://www.zonmw.nl |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
