|- candidate number||10625|
|- NTR Number||NTR3175|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2011|
|- Secondary IDs||11-N-92 METC HsZuyd/Orbis|
|- Public Title||Measuring conscious motor processing and movement self- consciousness in stroke patients using a Dutch version of the Movement Specific Reinvestment Scale.|
|- Scientific Title||Measuring conscious motor processing and movement self- consciousness in stroke patients using a Dutch version of the Movement Specific Reinvestment Scale.|
|- ACRONYM||MSRS in stroke|
|- hypothesis||Main question:|
What is the value of the propensity for reinvestment (measured by the Movement Specific Reinvestment Scale) in predicting the functional mobility (measured with he Rivermead Mobility Index) of stroke patients after 15 weeks of rehabilitation?
The hypothesis is that a high propensity for reinvestment has a negative influence on the motor learning process and will thus affect the level of mobility negatively.
Does the degree of reinvestment of stroke patients (measured by the Movement Specific Reinvestment Scale = MSRS) change during the rehabilitation period of fiteen weeks?
The expectation is that the stroke patients will score high on the MSRS scale at baseline because of their high degree of awareness of their movements immediately after the stroke. the expectation is that the scores will be lower at the end of the rehabilitation period caused by a better body image and a higher self-esteem of the patient.
|- Healt Condition(s) or Problem(s) studied||Stroke, Stroke, Movement Specific Reinvestment Scale, Functional mobility, Reinvestment|
|- Inclusion criteria||1. Adult;|
2. Clinically diagnosed stroke;
3. Patients <6 weeks after stroke.
|- Exclusion criteria||Severe additional impairents prior to stroke.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||12-dec-2011|
|- planned closingdate||23-mrt-2012|
|- Target number of participants||53|
|- Interventions||No intervention given. The stroke patients only received care as usual.|
|- Primary outcome||1. Conscious motor processing and movement self- consciousness measured by the Movement Specific Reinvestment Scale;|
2. The locomotion measured by the Rivermead Mobility Index.
|- Secondary outcome||1. The amount of ADL- independence and mobility measured by the Barthel Index and the Rivermead Mobillity Index;|
2. Random Movement Activity measured by the Motricity Index;
3. Fear and depression measured by the Hospital Anxiety Depression Scale.
|- Timepoints||1. Baseline measurement on the moment of intake in the rehabilitation clinic;|
2. The second measurement is fifteen weeks after the baseline measurement.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. Melanie Kleynen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Melanie Kleynen|
|- Sponsor/Initiator ||Hogeschool Zuyd|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Movement disruption and reinvestment have been investigated in athletes and in the healthy population. It has been shown that the ‘Reinvestment Scale’ (RS) may predict whether someone will fail when performing movements under (psychological) pressure.
The adapted version of the RS, the ‘Movement Specific Reinvestment Scale’ (MSRS) has been developed for the use in rehabilitation and has recently been used in two exploratory studies in patients with Parkinson’s disease and Stroke. This scale has been translated into Dutch according to the guidelines for cross cultural adaptation processes.
The aim of this study is to investigate the predictive validity of the MSRS for functional mobility in patients after stroke 15 weeks after onset.
Observational longitudinal design.
Adult stroke patients in the acute and subacute phase will be recruited from the neurological ward of the Orbis Medical Centre located in Sittard.
Main study parameters/endpoints:
Measurement dates are at entry (baseline- T0) and after 15 weeks (T1). The following patient characteristics will be collected: age, gender, brain lesion site, co-morbidities or complications. The primary outcome is the ‘Movement Specific Reinvestment Scale’. As additional measurements on functional outcome are used: the Rivermead Mobility Index (and the Barthel Index. To build the prediction model the following possible predictors will be measured: random motion activity (measured with the Motricity Index) and the level of fear and depression (measured with the Hospital Anxiety Depression Scale).
|- Main changes (audit trail)|
|- RECORD||5-dec-2011 - 19-jan-2012|