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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: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN40128145
Date of registration: 15/09/2014
Prospective Registration: No
Primary sponsor: Erasmus Medical Center (Netherlands)
Public title: 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
Scientific title: 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: 01/10/2012
Target sample size: 40
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN40128145
Study type:  Interventional
Study design:  Randomized controlled experiment (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Netherlands
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Hans    Bussmann
Address:  Postbus 2040 3000 CA Rotterdam Netherlands
Telephone: -
Email: j.b.j.bussmann@erasmusmc.nl
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Upper limb motor problems after stroke
Circulatory System
Intervention(s)
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.
Primary Outcome(s)
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).
Secondary Outcome(s)
No secondary outcome parameters
Secondary ID(s)
N/A
Source(s) of Monetary Support
Adriaan Children's Foundation (KinderFonds Adriaanstichting) (Netherlands) grant number 2010/0098
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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