Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000812998
Ethics application status
Approved
Date submitted
30/07/2011
Date registered
3/08/2011
Date last updated
3/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise-based videogames for stroke rehabilitation at home: a single subject randomised trial
Scientific title
The feasibility and efficacy of exercise-based videogames for upper and lower limb stroke rehabilitation at home: a single subject randomised trial
Secondary ID [1] 262581 0
NIL
Universal Trial Number (UTN)
U1111-1122-6771
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 268245 0
Condition category
Condition code
Neurological 268377 268377 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 270631 270631 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A crossover study design will be used. There will be 4 two-week intervention periods. During each intervention period, the participant will use exercise-based videogames (X-Box Kinect and Apple I-pad) independently at home. These videogames will be setup in the participant's home 2 weeks prior to beginning the first intervention period to enable a 2-week unblinded 'run-in' period. During each intervention period, either upper limb or lower limb videogame exercise will be undertaken. There will be no 'washout period' between the intervention periods. The participant will be asked to perform as much practice using the videogames as possible within their normal daily routine, and to progress to more physically challenging games as able. The videogames used and their intensity or difficulty will be participant selected, however an experienced clinical physiotherapy neurology specialist will be available via phone to assist the participant with any exercise-related questions. A technology specialist will also be available to assist with any videogame hardware issues.
Intervention code [1] 266913 0
Rehabilitation
Comparator / control treatment
The order of upper limb and lower limb exercise periods will be randomised to ensure two upper limb and two lower limb intervention periods. i.e. The 2 week upper limb intervention periods will serve as a control for the 2 week lower limb intervention periods and vice versa.
Control group
Active

Outcomes
Primary outcome [1] 269161 0
Choice stepping reaction time (Lord and Fitzpatrick 2001)
Timepoint [1] 269161 0
Baseline, 10 days (at least) of each 14 day intervention period, and at 8 weeks.
Primary outcome [2] 269162 0
Upper limb reach time. The average time of 3 trials will be used at each timepoint. This test will measure the time it takes the participant to reach with their affected upper limb to click a computer mouse positioned on a table in front of them while seated in response to the illumination of a red light. The test is commenced by the participant clicking a 'start button' with their intact hand. The participant then tries to reach with their affected arm as fast as they can, from a starting position of palm down on their affected thigh, to click the mouse positioned on the table in front of them at a standardised distance, approximating full elbow extension. The mouse is connected to an electronic timer which will display the time elapsed from the illumination of a red light to the pressure of the participant's index finger on the mouse key. The time it takes for the red light to illuminate after the start button is pressed is random.
Timepoint [2] 269162 0
Baseline, 10 days (at least) of each 14 day intervention period, and at 8 weeks.
Secondary outcome [1] 279115 0
High-level Mobility Assessment Tool total score (Williams et al, 2010). This tool quantifies high-level mobility tasks such as walking on toes, running and hopping.
Timepoint [1] 279115 0
Baseline and 8 weeks
Secondary outcome [2] 279116 0
Step Test (Hill et al 1996). The number of steps in 15 sec of 1)the affected, 2)unaffected, and 3)both legs alternately will be assessed using a 7.5 cm step.
Timepoint [2] 279116 0
Baseline and 8 weeks
Secondary outcome [3] 279117 0
Six-minute walk distance.
Timepoint [3] 279117 0
Baseline and 8 weeks
Secondary outcome [4] 279118 0
3 metre forward tandem (heel-to-toe) walk time
Timepoint [4] 279118 0
Baseline and 8 weeks
Secondary outcome [5] 279119 0
Action Research Arm Test total and subgroup scores (Yozbatiran et al 2008)
Timepoint [5] 279119 0
Baseline and 8 weeks
Secondary outcome [6] 279120 0
Summed score of the Motor Assessment Scale upper limb items (6, 7, and 8) (Pickering et al 2010).
Timepoint [6] 279120 0
Baseline and 8 weeks
Secondary outcome [7] 279121 0
Box and Block Test (Mathiowetz et al, 1985).
Timepoint [7] 279121 0
Baseline and 8 weeks
Secondary outcome [8] 279126 0
System Usability Scale (Digital Equipment Corporation, 1986). The System Usability Scale is a 10-item Likert scale that provides a global view of subjective assessments of usability. It will be used to determine the participant's subjective assessment of usability of 1)lower limb videogames, and 2)upper limb videogames used in this study.
Timepoint [8] 279126 0
8 Weeks
Secondary outcome [9] 279127 0
Total time spent engaged in upper limb and lower limb exercise-based videogames. The participant will keep a daily recording log of time spent using each exercise-based videogame for the lower limb. The upper limb exercise-based videogame duration will be captured by the software automatically.
Timepoint [9] 279127 0
Average time/day, as well as 2 week, and 8 week totals will be analysed.
Secondary outcome [10] 279137 0
Subjective video assessment of walking, and running by an experienced neurological physiotherapist.
Timepoint [10] 279137 0
Baseline and 8 weeks
Secondary outcome [11] 279414 0
Physical Functioning.
This will be assessed using the Basic Mobility and Daily Activity domains of the Computer Adaptive Testing version of the Boston University Activity Measure for Post Acute Care (AM-PAC) (Haley et al 2004). The AM-PAC measures functional outcome by using Item Response Theory. The AM-PAC Basic Mobility domain includes 101 items that address basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. The AM-PAC Daily Activity domain includes 70 items that address basic self care and instrumental activities of daily life.
Timepoint [11] 279414 0
Baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks

Eligibility
Key inclusion criteria
The single participant is a long-term adult stroke survivor. He has ongoing lower limb and upper limb motor coordination problems on his affected side. He is able to walk independently and use his affected arm for daily tasks. He lives independently within the community.
Minimum age
51 Years
Maximum age
51 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation of the participant to the sequence of upper and lower limb intervention periods will be carried out by contacting the holder of the allocation schedule who is 'off-site'. The investigators did not know the order of UL/ LL conditions when determining the participant's eligibility.
The participant is active in the Stroke Recovery Association. A colleague (Professor Lindley) met the participant at Stroke Recovery Association events and introduced him to the investigators. The investigators have designed the study in consultation with the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of 2 week upper limb and lower limb exercise-based videogame periods will be randomised using a blocked randomisation schedule to ensure two upper limb and two lower limb intervention periods over an 8 week period.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Single-subject randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267437 0
Hospital
Name [1] 267437 0
Bankstown Lidcombe Hospital
Country [1] 267437 0
Australia
Funding source category [2] 267441 0
Other Collaborative groups
Name [2] 267441 0
Ingham Institute for Applied Medical Research
Country [2] 267441 0
Australia
Funding source category [3] 267442 0
Other Collaborative groups
Name [3] 267442 0
Neuroscience Research Australia
Country [3] 267442 0
Australia
Primary sponsor type
Individual
Name
Mr Bradley Lloyd
Address
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country
Australia
Secondary sponsor category [1] 266485 0
Individual
Name [1] 266485 0
A/Prof Catherine Sherrington
Address [1] 266485 0
The George Institute for Global Health
PO Box M201
Missenden Road
Sydney
NSW 2050
Country [1] 266485 0
Australia
Secondary sponsor category [2] 266486 0
Individual
Name [2] 266486 0
Mr Karl Schurr
Address [2] 266486 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country [2] 266486 0
Australia
Secondary sponsor category [3] 266487 0
Individual
Name [3] 266487 0
Dr Stuart Smith
Address [3] 266487 0
Neuroscience Research Australia
PO Box 1165
Randwick NSW 2031
Australia
Country [3] 266487 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269363 0
The University of Sydney
Ethics committee address [1] 269363 0
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 269363 0
Australia
Date submitted for ethics approval [1] 269363 0
06/06/2011
Approval date [1] 269363 0
23/06/2011
Ethics approval number [1] 269363 0
06-2011 / 13887

Summary
Brief summary
The primary aims of the study include 1)to determine whether 8 weeks of exercise-based videogame exercise performed at home independently by a chronic stroke survivor is feasible; and 2) to determine whether exercise-based videogames used at home independently by a chronic stroke survivor improve upper and lower limb motor coordination. A single-subject randomised controlled trial design will be used. The participant is an independently-living 51 year old long-term male stroke survivor with ongoing lower limb and upper limb motor coordination problems on his affected side. The participant will practise upper limb and lower limb exercise-based videogames independently at home over an 8-week period (2 x 2 weeks of upper limb exercise-based videogames, and 2 x 2 weeks of lower limb exercise-based videogames). The order of the upper limb and lower limb exercise periods will be randomised. The participant will practise the games as much as possible during his normal daily routine. The primary outcomes include choice stepping time (lower limb) and arm reach reaction time (upper limb). Secondary outcomes include the High-level Mobility Assessment Tool, tandem walk, step test, 6-minute walk, upper limb items of the Motor Assessment Scale, Box-and-Block Test, Action Research Arm Test, System Usability Scale, and subjective gait video assessment. This study will provide valuable information on the feasibility and efficacy of using exercise-based videogame exercises in the home after stroke
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32840 0
Address 32840 0
Country 32840 0
Phone 32840 0
Fax 32840 0
Email 32840 0
Contact person for public queries
Name 16087 0
Mr Bradley Lloyd
Address 16087 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country 16087 0
Australia
Phone 16087 0
+ 61 2 9722 7095
Fax 16087 0
Email 16087 0
[email protected]
Contact person for scientific queries
Name 7015 0
Mr Bradley Lloyd
Address 7015 0
Bankstown Lidcombe Hospital
Physiotherapy Department
Locked Bag 1600
Bankstown
NSW 2200
Country 7015 0
Australia
Phone 7015 0
+ 61 2 9722 7095
Fax 7015 0
Email 7015 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.