Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000937718
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
26/08/2013
Date last updated
26/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Viewing Video Images of Motor Skills followed by Physical Practice for Stroke Rehabilitation
Scientific title
Action Observation Training with Intent to Mimic for Stroke Rehabilitation
Secondary ID [1] 283045 0
Nil
Universal Trial Number (UTN)
U1111-1146-9731
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 289880 0
Condition category
Condition code
Stroke 290243 290243 0 0
Ischaemic
Stroke 290244 290244 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this pilot study is to explore whether chronic stroke survivors who observe digital video images of basic movements (e.g., a healthy person picking up a cup), and then, directly after each observation attempt to physically mimic the observed action improve their motor function (the intervention). The purpose of this training is to activate mirror neurons to prime the motor system for regaining possible motor skill function. This will be examined using a within-subject design. The intervention phase will consist of three one hour sessions per week delivered over two weeks. Each one hour session will involve approximately five different motor skill tasks with 10-15 repetitions of each.
Intervention code [1] 287764 0
Rehabilitation
Comparator / control treatment
In the within subject design, subjects will undergo a control phase prior to the intervention phase. Control phase will involve viewing random dynamic environmental images (videos) prior to physically practising selected motor skills. This is aimed not to activate the mirror neuron system (and prime the motor system) as the intervention is hoped to. The control phase will consist of three one hour sessions per week delivered over two weeks. Each one hour session will involve approximately five different motor skill tasks with 10-15 repetitions of each. There will be no wash out period between the control and intervention phases.
Control group
Active

Outcomes
Primary outcome [1] 290263 0
Sensorimotor function of Upper extremity using Fugl-Meyer Assessment - Upper Extremity (FMA-UE). This outcome will be assessed approximately 2 days pre and post control phase and approximately 2 days post intervention due to the time required for assessment.
Timepoint [1] 290263 0
Pre- and Post- control phase and Post- intervention phase
Primary outcome [2] 290264 0
Goal achievement of Functional motor skills using Functional Test of the Hemiplegic/paretic Upper Extremity (FTHUE). This outcome will be assessed approximately 2 days pre and post control phase and approximately 2 days post intervention due to the time required for assessment.
Timepoint [2] 290264 0
Pre- and Post- control phase and Post- intervention phase
Primary outcome [3] 290265 0
Range of motion at the elbow joint using three-dimensional Kinematic analysis (sub-sample only). This outcome will be assessed approximately 2 days pre and post control phase and approximately 2 days post intervention due to the time required for assessment.
Timepoint [3] 290265 0
Pre- and Post- control phase and Post- intervention phase
Secondary outcome [1] 304222 0
Confidence in using impaired limb assessed using Self-efficacy questionnaire (adapted from extremity constraint-induced therapy evaluation - EXCITE trial). This outcome will be assessed approximately 2 days pre and post control phase and approximately 2 days post intervention due to the time required for assessment.
Timepoint [1] 304222 0
Pre- and Post- control phase and Post- intervention phase

Eligibility
Key inclusion criteria
The following inclusion and exclusion criteria have been based upon availability and capability to recruit chronic stroke survivors during an honours degree.
Inclusion criteria:
(a) 18 years old and over
(b) those not in an in-patient rehabilitation program of a hospital
(c) those participants who have had a stroke that has impaired normal function of their upper limb, but where they have some capability to move the limb (Functional assessment score between 20 to 55 of a standard test Fugl-Meyer).
(d) able to communicate effectively with investigator in order to complete testing and intervention
sessions tasks
(e) able to commit to time requirements of testing and intervention phases

Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
(a) Under 18 years of age
(b) not meeting (b) to (e) of the inclusion criteria.
(c) spatial neglect (impairment to a section of the visual field)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287810 0
Self funded/Unfunded
Name [1] 287810 0
Country [1] 287810 0
Primary sponsor type
University
Name
Murdoch University
Address
90 south Street, Murdoch 6150, WA
Country
Australia
Secondary sponsor category [1] 286537 0
None
Name [1] 286537 0
Address [1] 286537 0
Country [1] 286537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289760 0
Murdoch University Human Ethics Committee
Ethics committee address [1] 289760 0
Ethics committee country [1] 289760 0
Australia
Date submitted for ethics approval [1] 289760 0
Approval date [1] 289760 0
16/08/2013
Ethics approval number [1] 289760 0
2013/130

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42274 0
Dr Sean Muller
Address 42274 0
Murdoch University
School of Psychology and Exercise Science
90 South Street
Murdoch 6150, WA
Country 42274 0
Australia
Phone 42274 0
+618 9360 2089
Fax 42274 0
Email 42274 0
[email protected]
Contact person for public queries
Name 42275 0
Sean Muller
Address 42275 0
Murdoch University
School of Psychology and Exercise Science
90 South Street
Murdoch 6150, WA
Country 42275 0
Australia
Phone 42275 0
+618 9360 2089
Fax 42275 0
Email 42275 0
[email protected]
Contact person for scientific queries
Name 42276 0
Sean Muller
Address 42276 0
Murdoch University
School of Psychology and Exercise Science
90 South Street
Murdoch 6150, WA
Country 42276 0
Australia
Phone 42276 0
+618 9360 2089
Fax 42276 0
Email 42276 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.