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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3 February 2020 |
Main ID: |
ISRCTN40903497 |
Date of registration:
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20/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Mirror therapy for the lower extremity after stroke
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Scientific title:
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Mirror, mirror, in therapy, whose leg moves with the most dexterity? A pilot study of a lower extremity, multi-joint mirror therapy intervention after stroke |
Date of first enrolment:
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01/11/2015 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN40903497 |
Study type:
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Interventional |
Study design:
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Randomized controlled pilot study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Canada
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Contacts
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Name:
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Kara
Patterson |
Address:
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550 University Avenue
M5G 2A2
Toronto
Canada |
Telephone:
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+1 416 946 8549 |
Email:
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kara.patterson@utoronto.ca |
Affiliation:
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Name:
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Anthony
Aqui |
Address:
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11-107 - 550 University Avenue
M5G 2A2
Toronto
Canada |
Telephone:
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+1 416 597 3422 ext 7826 |
Email:
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anthony.aqui@uhn.ca |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. First time occurrence of stroke 2. Normal or corrected to normal vision 3. Chedoke McMaster Stroke Assessment (CMSA) leg and foot score of 2 or greater 4. Passive ankle dorsiflexion to neutral, passive knee flexion to 60 degrees and passive hip flexion to 100 degrees 5. Have been admitted to the stroke rehabilitation program at the Toronto Rehabilitation Institute
Exclusion criteria: 1. Visual neglect or inadequate vision that would impede the viewing of the mirror’s surface 2. Bilateral stroke or bilateral sensorimotor impairments 3. Inability to comprehend and/or follow multiple step instructions
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke Nervous System Diseases Stroke
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Intervention(s)
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Participants are randomly allocated to one of two groups:
Mirror Therapy intervention group: Participants will be positioned in long-sitting on a plinth with back support and a mirror at the participant’s midline. Participants will then perform repeated bilateral hip and knee flexion-extension and ankle dorsiflexion movements and/or repeated bilateral hip adduction and abduction movements . The affected limb will be placed behind a curtain to block the participant’s view of that limb. The unaffected limb will be positioned outside the curtain such that the movements are reflected in the mirror. The entire apparatus will be positioned to create the illusion of the affected limb moving as the unaffected limb would. Participants will be instructed to observe the reflection of their unaffected limb while performing the bilateral LE exercise.
Control intervention group: Participants will be positioned in the same manner as described for the MT invention group. Participants will also perform the same repeated bilateral hip and knee flexion-extension and ankle dorsiflexion movements. The MT apparatus will also be used, however the mirror will be replaced with a non-reflective board.
All participants will attend 10-15 training sessions. The exact amount will vary depending on the individuals’ length of stay in rehabilitation. A goal of 30 minutes for the duration of each intervention session will be set but the actual duration will be guided by patient tolerance.
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Primary Outcome(s)
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1. Degree of motor impairment is measured using the Chedoke McMaster Stroke Assessment before and after the participant completes the mirror therapy sessions 2. Over-ground gait performance is measured using spatiotemporal gait parameters before and after the participant completes the mirror therapy sessions. Parameters of interest are gait velocity and temporal gait symmetry. Gait symmetry will be calculated using a ratio of left and right limb values for swing time as outlined in previous work. 3. EMG gait profile is measured by recording EMG activity bilaterally from the tibialis anterior, medial gastrocnemius, vastus lateralis and biceps femoris before and after the participant completes the mirror therapy sessions. Footfall events are recorded using insole foot switches.
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Secondary Outcome(s)
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1. Standing balance is measured using the Berg Balance Scale before and after the participant completes the mirror therapy sessions 2. Motor coordination is measured before and after the participant completes the mirror therapy sessions using the finger to nose test and the heel to shin test. These tests are video recorded with a digital camera to later analyse for performance and quality of movement 3. Electrodermal activity is measured during the first and last mirror therapy session completed by the participant 4. Electroencephlogram activity (EEG) and EMG activity coherence is measured during the first and last mirror therapy session completed by the participant
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Source(s) of Monetary Support
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Physiotherapy Foundation of Canada
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Ethics review
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Status:
Approval date:
Contact:
The University Health Network Research Ethics Board, 17/10/2014, ref: 14-7482-DE
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/12/2016 |
URL:
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