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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ANZCTR |
Last refreshed on:
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15 July 2019 |
Main ID: |
ACTRN12617000745347 |
Date of registration:
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22/05/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Interactive Virtual Therapy for community-dwelling Stroke survivors
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Scientific title:
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Efficacy of an innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.
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Date of first enrolment:
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01/08/2017 |
Target sample size:
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60 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12617000745347.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Wei-Peng Teo
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Address:
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Faculty of Health
Deakin University
221 Burwood Highway
Burwood, Victoria, 3125
Australia |
Telephone:
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+61 3 9244 5229 |
Email:
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weipeng.teo@deakin.edu.au |
Affiliation:
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Name:
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Dr Wei-Peng Teo
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Address:
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Faculty of Health
Deakin University
221 Burwood Highway
Burwood, Victoria, 3125
Australia |
Telephone:
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+61 3 9244 5229 |
Email:
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weipeng.teo@deakin.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Participants will be included if they are 1) community dwelling stroke survivors, 2) with mild-to-moderate upper arm impairments (Fugl-Meyer upper extremity score 25-45), 3) no cognitive impairments (Mini-mental state examination score >24) and 4) able to read English.
Exclusion criteria: Stroke survivors with 1) other neurological conditions (e.g. Parkinson’s disease or dementias) and 2) no observable movements in shoulders or elbows will be excluded from this trial.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Stroke - Haemorrhagic
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Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation
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Stroke - Ischaemic
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Stroke; loss of arm function; Stroke loss of arm function
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Intervention(s)
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The intervention will be participation in interactive computer based activities using the kinect camera and software designed for stroke rehabilitation (JRS wave technology). Participants will view screen based activities and perform tasks that give feedback on arm and body position in space. Between 3 and 5 upper limb exercises will be performed which are functional upper limb tasks that require shoulder flexion, abduction and adduction with elbow flexion, extension and forearm supination. the dose will be for up to 50 minutes twice per week in a community setting for 8 weeks. Sessions will be supervised by an exercise physiologist 1:1 face to face and attendance recorded. The software records duration and number of activities participated in.
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Primary Outcome(s)
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The primary outcome of upper limb function will be measured using composite scores 1.The Fugl-Meyer Upper Extremity (FMUE) scale, 2. Upper limb spasticity as measured by the Modified Ashworth Scale 3.Motor Activity Log-28 (MAL-28) for daily arm use [Baseline and at 8 weeks]
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Stroke-Specific Quality-of-Life (SS-QoL) scale to measure the impact of reduced arm use.[Baseline and at 8 weeks]
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Secondary Outcome(s)
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Changes in cortical activation during motor tasks by functional near-infrared spectroscopy (fNIRS)
[Baseline and at 8 weeks]
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Heart Foundation Australila
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Ethics review
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Status: Approved
Approval date:
Contact:
Deakin University Research Ethics Commiteee
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Results
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Results available:
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Yes |
Date Posted:
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26/06/2019 |
Date Completed:
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29/08/2018 |
URL:
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