|- candidate number||5508|
|- NTR Number||NTR1735|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-mrt-2009|
|- Secondary IDs||08-T-76 MEC Heerlen|
|- Public Title||Exploring the effects of mental practice on physical activity and autonomy in Parkinson patients. |
|- Scientific Title||Mental practice embedded in therapy of patients with Parkinson’s disease in Dutch physiotherapy practices.|
|- ACRONYM||MIND-ParkT: Moving In a New Direction – Parksinson Trial|
|- hypothesis||To investigate the therapeutic potential of mental practice embedded in daily therapy on the improvement in daily activities of adult patients with Parkinson’s disease. In the Parkinson’s study, MP embedded in therapy will be compared to therapy as usual alone. The additional research question investigates the feasibility of the mental practice-based therapy as judged by the patients and therapists.|
|- Healt Condition(s) or Problem(s) studied||Parkinson's disease|
|- Inclusion criteria||1. Clinically diagnosed adult patients with Parkinson’s disease; |
2. Sufficient cognitive level and communication skills to engage in mental practice; this is a clinical judgement. Hoehn and Yahr classification: 1-3.
|- Exclusion criteria||Severe additional impairments prior to disease onset.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-feb-2009|
|- planned closingdate||2-feb-2010|
|- Target number of participants||38|
|- Interventions||The experimental group will receive therapy in which mental practice is routinely used with the physical therapy given. Embedded MP will be used.|
The control group will receive therapy as usual in accordance with the Dutch Physiotherapy Guidelines for Parkinson’s disease. To compensate for the unguided imagery training, patients in the control group will be motivated to do homework as well (physical training and listening to a relaxation CD).
As the experimental group will receive more attention due to keeping a log and being interviewed, patients in the control group will be instructed to use logs as well and will be interviewed on their opinion on therapy as usual.
|- Primary outcome||To measure if MP improves the performance of activities in the experimental group more than in the control group an 11-point numerical rating scale will be used:
11 point Numerical rating scale assesses changes in the performance of the activity ‘walking’ ranging from 10 (‘excellent’) to 0 (‘poor’) as perceived by the patient and the therapist.
|- Secondary outcome||1. Timed up and go (TUG - activity level);|
2. 10 meter walking test (TML - activity level).
|- Timepoints||Measurement dates are at entry in the study for three weeks (T0/ T1/ T2 – baseline) and after a 6 weeks intervention period for three weeks (T3/ T4/ T5). After three months follow-up measurements will take place (T6/ T7/ T8).|
|- Trial web site||aenp.hszuyd.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr Susy Braun|
|- CONTACT for SCIENTIFIC QUERIES||Dr Susy Braun|
|- Sponsor/Initiator ||Research Centre for Autonomy and Participation |
(Source(s) of Monetary or Material Support)
|Research Centre for Autonomy and Participation |
|- Brief summary||Mental practice as an embedded or additional therapy is getting increased attention in rehabilitation/therapy in different patient populations (stroke, Parkinson’s disease (PD), chronic pain etc.) Systematic reviews of studies undertaken so far in stroke and other pathologies show that there may be some evidence that the technique might be effective. In the Netherlands, little mental practice research is done in private practices in the community. This study investigates whether mental practice can contribute to a quicker and/or a better improvement in patients with Parkinson’s disease in daily living.|
|- Main changes (audit trail)|
|- RECORD||24-mrt-2009 - 23-sep-2009|