Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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17 October 2016 |
Main ID: |
ISRCTN40128145 |
Date of registration:
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15/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The effects of a mirror therapy based action observation protocol to improve motor learning of the affected upper arm in patients in the chronic stage after stroke
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Scientific title:
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The effects of a mirror therapy based action observation protocol to improve motor learning of the affected upper arm in patients in the chronic stage after stroke: a randomized controlled experiment |
Date of first enrolment:
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01/10/2012 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN40128145 |
Study type:
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Interventional |
Study design:
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Randomized controlled experiment (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Hans
Bussmann |
Address:
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Postbus 2040
3000 CA
Rotterdam
Netherlands |
Telephone:
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- |
Email:
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j.b.j.bussmann@erasmusmc.nl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. At least 6 months after stroke 2. Brunnstrom score for upper-extremity function between III and VI 3. Home dwelling status
Exclusion criteria: 1. Participants with neglect (indicated by the star cancellation test and/or reported by the occupational therapist or psychologist), 2. Co-morbidities that influence voluntary upper-extremity function 3. Participants who suffered from multiple strokes
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Upper limb motor problems after stroke Circulatory System
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Intervention(s)
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Participants were randomly allocated to the action observation (AO) or control observation (CO) group. To minimize possible confounding effects of age and motor ability, participants were stratified into four groups based on age (younger than 55 years of age or 55 years and older) and motor function (assessed with the Fugle Meyers Assessment (FMA), FMA score < 50 or a FMA score > 50). The randomization procedure was concealed; participants had to pick a sealed envelope before training. Participants had to train a simple upper limb reaching movement. The training contained 7 sets of 10 affected arm reaching movements, alternated with periods of observation (AO or CO).
Participants enrolled to the AO group observed video tapes with upper-arm reaching movements that were offered in such a way the AO is almost similar to the mirror reflection during mirror therapy. To provide participant-specific videos, reaching movements from the non-affected arm were video-taped and mirrored to create maximal postural familiarity and the illusion that the affected arm performed the reaching movements in a normal movement pattern.
Participants enrolled into the control observation (CO) group will observe a slideshow with static photographs of landscapes as control stimuli. The photographs contained no images of humans or animals and are selected not to trigger the mirror neuron system and therefore not likely to interfere with the goal in this study.
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Primary Outcome(s)
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The beneficial effects of AO will be assessed by analysing the performance of the simple upper arm reaching task. Primary outcome measure is movement time (s) of the reaching task
As this study is an experimental study, patients only train for 30-45 minutes, so outcome will be measured before the start of the single training session (baseline) and after training (follow-up).
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Secondary Outcome(s)
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No secondary outcome parameters
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Source(s) of Monetary Support
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Adriaan Children's Foundation (KinderFonds Adriaanstichting) (Netherlands) grant number 2010/0098
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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