Mental Practice in Stroke Rehabilitation

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR993
• Date of registration: 06/06/2007
• Primary sponsor: Hogeschool Zuyd
• Public title: Mental Practice in Stroke Rehabilitation
• Scientific title: Mental practice embedded in stroke rehabilitation: a randomised controlled, multi-centre trial - MIND (Moving In a New Direction)
• Date of first enrolment: 1/10/2007
• Target sample size: 70
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=993
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: Susy Braun

• Name: Susy Braun

Key inclusion & exclusion criteria

Inclusion criteria: 1.Clinically diagnosed adult stroke patient; there is no evidence that MP only works in first ever strokes. (Moreover, it is not certain whether a clinically diagnosed first stroke is indeed the first.);
2. Sufficient cognitive level and communication skills to engage in mental practice; this is a clinical judgement. Patients need to be able to follow simple instructions.

Exclusion criteria: 1. Severe additional impairments prior to stroke.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Stroke, Rehabilitation, Autonomy, Mental training

Intervention(s)

All patients included in the study will receive 6 weeks of multi professional approach interventions. The control group will receive therapy as usual. The experimental group will receive therapy as usual in which MP-techniques and ¡Vprinciples are embedded in every paramedical therapy session. Six paramedical therapists working at the Klevarie Nursing Home and six paramedical therapists working at Nursing Home St. Camillus will be instructed on how to treat the patients in the experimental group (two occupational, two physical and two speech therapists). Patients allocated to the control group can be treated by any of the therapists. To prevent/limit contamination in therapy of the instructed therapists, an expert (also the trainer of MP for the participating therapists) will monitor the contrast between the experimental and control therapy.
Experimental intervention
The experimental group will receive therapy in which mental practice is embedded in every occupational, speech or physical therapy. We choose embedded MP for several reasons. There is some evidence that mental rehearsal should be combined regularly with the overt movement to increase imagery vividness. Second, improving skills seems to depend on continuous practice. In addition, we believe that a higher training intensity will not only increase skills but also consolidate the MP technique, making the patient more confident that he/she is practicing correctly and thereby increasing compliance and motivating patients to practice unguided. The experimental intervention period is divided into four phases.
Patients will first be familiarised with MP-based therapy and educated by an expert as to basic imagery principles and the importance of imagery training on a regular basis (phase 1). The expert will therefore instruct all the patients in the experimental group in phase 1. There is some evidence that patients educated on and familiarised with the technique are more likely to practice in general a

Primary Outcome(s)

It is hypothesised that MP has the most effects on the movement that is actually mentally rehearsed. Improvement of these activities should therefore be assessed. To measure if MP improves the performance of activities in the experimental group more than in the control group an 11-point Likert scale will be used:
11 point Likert scale assesses changes in the performance of the activities 'drinking' and 'walking' ranging from 10 ('excellent') to 0 ('poor') as perceived by the patient and the therapist.

Secondary Outcome(s)

1. Motricity Index (MI ¡V function (impairment) level)
The Motricity Index evaluates voluntary movement activity and the maximum muscle strength with a 6 point Likert Scale. Reliability and Validity are sufficient in stroke populations.(43) This is a staff-completed index of limb movement aiming to measure general motor impairment. Three movements for each limb are assessed based on the MRC strength grades and weighted; 0 for no movement, 9 for palpable movement, 14 for movement seen, 19 for full range against gravity, 25 for movement against resistance and 33 for normal movement. The side score is the sum of the arm and leg score, divided by two. The minimum score is 0 and the maximum score is 100. The higher the score the less motor impaired;
2. Barthel Index (BI ¡V activity level)
With the Barthel Index the degree of independent performance of daily activities is measured.(44) Several versions exist. In this study an assessment form with a 20 points scale will be used.(44) The BI has 10 items. Scores per item vary from a 2- (0-1) to a 4-point (0-3) Likert Scale. The BI is a reliable and valid test. The test is known to have a ceiling effect.(43) Therefore, it seems more useful in the first 6 months post stroke. Values are assigned to each item based the need for physical assistance to perform the activity. The minimum score is 0 and the maximum score is 20. The higher the score the greater the independence.
3. Nine Hole Peg Test (NHPT ¡V function (activity) level). The NHPT is a measuring instrument in which the speed of the fine hand coordination is assessed. The patient has to take nine little pins from a tray, one at a time, as fast as possible and place them in a pegboard. The time needed to complete the attempt is recorded. Only the hand that is being assessed may be used. The reliability and validity are sufficient. (45-47);
4. Rivermead Mobility Index (RMI ¡V activity level). This is a staff-completed questionnaire to measure mobility disability after head injury, MS, stroke and other conditions. It comprises of 14 questions (activities scored range from turning over in bed to running) and 1 direct observation of standing for 10 seconds. Each answer is scored ¡¥Yes¡¦ (1) or ¡¥No¡¦ (0). The minimum score is 0 and the maximum score is 15. The higher the score the better the mobility.
5. 10 meter walking test (TML - activity level). The 10 meter walking test can be used in patients able to walk independently with or without walking aids and / or orthoses. Patients should walk at a comfortable speed. The test is reliable, valid and responsive. (43) Furthermore, a significant relation between the comfortable walking speed during the TML and the quality with which patients walk has been established. (48) Codes for not able (yet) and independent in wheelchair are 0 resp. 1.
6. Timed up and go (TUG - activity level)
The TUG measures the time a patient needs to stand up from a chair, walk 3 meters at a comfortable speed, turn around, walk back and sit down. The patient is allowed to use his/her own walking aids, but no physical assistance may be given by the researcher or therapist. The test is practical and simple. The internal consistency, reliability, validity and responsiveness are sufficient. (49-53)
7. Other study parameters (if applicable)
Optional:
a. QEEG (Brain-activity ¡V neurophysiological level)
In addition to the QEEG as a prognostic value, the mu suppression is used as an evaluative measure to assess progress in imagery techniques during the 6 weeks intervention period.
Suppression of the mu waves can be interpreted as movement related information processing. Measures of brain activity will be performed with a universal amplifier (MPAQ, Maastricht Instruments) and data acquisition software (IDEEQ, Maastricht Instruments). Eight sensors will be placed above the sensorimotor cortex at both hemispheres according to a standardized protocol. To ensure low skin impedance (< 5 kÙ), the skin will be cleaned with a lotion and a non-allergic gel will be used for better transmitting of the signal (Ten20 conductive gel). Results will be expressed in % of suppression of mu activity. Patients may refuse QEEG measures at T1 and T2 due to the additional load of 20 minutes per assessment. If necessary due to allergy, nickel-free electrodes will be used.

Secondary ID(s)

ISRCTN27582267

Source(s) of Monetary Support

Hogeschool Zuyd