Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000157471
Ethics application status
Approved
Date submitted
6/02/2016
Date registered
10/02/2016
Date last updated
10/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility and utility of using an accessible controller to improve motor and sensory function in people recovering from stroke through computer gaming: A randomised controlled pilot study.
Scientific title
The feasibility and utility of using an accessible controller to improve motor and sensory function in people recovering from stroke through computer gaming: A randomised controlled pilot study.
Secondary ID [1] 288478 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 297520 0
Condition category
Condition code
Stroke 297722 297722 0 0
Ischaemic
Stroke 297723 297723 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 297770 297770 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is to participate in individual computer gaming sessions with the use of a controller (called ‘Orby’) and laptop, which will be readily available over a three-week period. There is no set time period a participant must play each day, so they can choose how much they play, and which games they play over the three-week period. This will be used as an additional rehabilitation tool during standard inpatient rehabilitation The games have been designed to be of broad appeal and easy to play (no experience required). The controller unit requires bimanual control whereby the impaired hand/arm is assisted to participate in the controller motion. The affected hand also receives task-relevant haptic (vibration) stimulation during the gaming with the intent of increasing self-perception of the affected hand. The gaming software will record all usage time of participants.
Intervention code [1] 293826 0
Rehabilitation
Intervention code [2] 293827 0
Treatment: Devices
Comparator / control treatment
The comparison group also uses bimanually the Orby controller for games but does not receive the haptic input.
Control group
Active

Outcomes
Primary outcome [1] 297254 0
Motor function of the upper limb as assessed by the Wolf Motor Function Test
Timepoint [1] 297254 0
Baseline and after 3-week intervention
Primary outcome [2] 297255 0
Sensation of the upper limb as assessed by Semmes Weinstein Monofilaments, Distal Proprioception test, Grating Orientation Domes and Klingels Protocol (stereognosis)
Timepoint [2] 297255 0
Baseline and after 3-week intervention
Secondary outcome [1] 320482 0
Perceived utility and feasibility of the computer gaming system and Orby controller by participants and staff involved as assessed by a written questionnaire. These questionnaires was designed specifically for this study.
Timepoint [1] 320482 0
At completion of the 3-week intervention
Secondary outcome [2] 320483 0
Usage of the computer game as assessed by the computer game system
Timepoint [2] 320483 0
At completion of the 3-week intervention

Eligibility
Key inclusion criteria
Aged over 18 years old
Willing and capable to give informed consent
Diagnosed with first time stroke; either ischemic or hemorrhagic
Hemiparetic hand able to sit on Orby, either by itself or strapped
Having sufficient shoulder range of movement and control for hand to be strapped;
approximately 70 degrees shoulder flexion, neutral wrist and mid pronation/supination
Able to focus and respond to screen-based games
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significantly reduced vision or perception - unable to see/read computer screen
Behavioral issues that preclude participation in seated computer gaming tasks
Epilepsy
A fixed contracture that prevents passive opening of the hand to place on ‘Orby’
Inability to follow instructions and answer written questions in English

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)
Allocation involves contacting the holder of the allocation schedule who is at a central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation is not appropriate in this pilot study as the intervention is novel, however the aim is to recruit 30 participants.
Data related to the population, usage and questionnaire responses will be analysed descriptively, and outcome measures will be compared using a 2 (group: haptic OGS, non-haptic OGS) x 2 (Time point: pre- and post-intervention) analysis of variance (ANOVA). The level of statistical significance will be set at p < 0.05 for all tests. An effect size will also be calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/11/2015
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5231 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 12702 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 292822 0
University
Name [1] 292822 0
University of South Australia
Country [1] 292822 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
School of Health Sciences
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 291565 0
University
Name [1] 291565 0
Flinders University
Address [1] 291565 0
Flinders University
Medical Device Research Institute
School of Computer Science, Engineering and Mathematics
1284 South Road, Clovelly Park, SA 5042
Country [1] 291565 0
Australia
Other collaborator category [1] 278811 0
Hospital
Name [1] 278811 0
Hampstead Rehabilitation Centre
Address [1] 278811 0
Hampstead Rehabilitation Centre
Hampstead Stroke Unit
207-235 Hampstead Road
Northfield SA 5085
Country [1] 278811 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294328 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 294328 0
Level 4, Women’s Health Centre
Royal Adelaide Hospital
North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 294328 0
Australia
Date submitted for ethics approval [1] 294328 0
10/09/2015
Approval date [1] 294328 0
01/10/2015
Ethics approval number [1] 294328 0
Protocol 150916
Ethics committee name [2] 294329 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 294329 0
University of South Australia
North Terrace
Adelaide SA 5000
Ethics committee country [2] 294329 0
Australia
Date submitted for ethics approval [2] 294329 0
01/10/2015
Approval date [2] 294329 0
08/10/2015
Ethics approval number [2] 294329 0
Protocol 34926

Summary
Brief summary
Rehabilitation can be a long process for people after stroke, and needs to be intensive to drive functional recovery. Computer gaming is proposed as a way for people to increase their therapeutic time while engaged in enjoyable activities during their rehabilitation stay. This project will investigate if computing gaming, through the use of the OrbIT Gaming System, has benefits for people during their stroke rehabilitation.
Particularly, we are interested in finding out if participation in computer gaming will improve movement and sensation in the affected upper limb following a stroke. The study will also ask participants and staff about their experiences using this system. This study is being conducted as part of a Physiotherapy student honours project.
Participants are allocated (by chance) to one of two groups. Both groups will participate in the computer gaming activity using a novel controller and laptop, which will be readily available over a three-week period. The controller requires bimanual use – thus “forcing” the affected hand and arm to participate in directing motion of the unit. Further it is capable of delivering a haptic stimulation (vibration) to the affected hand only to theortically increase awareness of the affected hand. This will be used as an additional rehabilitation tool during each participant's stay at Hampstead Rehabilitation Centre, allowing as much use as possible.
The games have been designed to be of broad appeal and easy to play (no experience required). Participants will also receive the usual rehabilitation ('standard care'). All participants (regardless of group) will be asked to undergo assessment at the beginning of the study and after the three-week period (1 hour for each assessment). All participants will be asked specific questions after the three-week intervention through a written questionnaire. This will enable us to compare the effects of computer gaming.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63314 0
Ms Shannon Watchman
Address 63314 0
School of Health Sciences
City East Campus
University of South Australia
North Tce, Adelaide
SA 5000
Country 63314 0
Australia
Phone 63314 0
+61 401 451 739
Fax 63314 0
Email 63314 0
[email protected]
Contact person for public queries
Name 63315 0
Ms Shannon Watchman
Address 63315 0
School of Health Sciences
City East Campus
University of South Australia
North Tce, Adelaide
SA 5000
Country 63315 0
Australia
Phone 63315 0
+61 401 451 739
Fax 63315 0
Email 63315 0
[email protected]
Contact person for scientific queries
Name 63316 0
A/Prof Susan Hillier
Address 63316 0
International Centre for Allied Health Evidence
Division of Health Sciences
City East Campus
University of South Australia
North Tce, Adelaide
SA 5000
Country 63316 0
Australia
Phone 63316 0
+61 8 83022544
Fax 63316 0
+61 8 83022766
Email 63316 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

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