Condition category
Circulatory System
Date applied
07/12/2007
Date assigned
14/01/2008
Last edited
06/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.zonmw.nl

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

Results - basic reporting

Publication summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18405377
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23273853

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes