Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000478718
Ethics application status
Approved
Date submitted
29/04/2013
Date registered
30/04/2013
Date last updated
9/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual reality balance games as an addition to standard physiotherapy for community-dwelling stroke survivors.
Scientific title
Virtual reality balance games as an adjunct to standard physiotherapy to improve physical function and activities of daily living for community-dwelling stroke survivors.
Secondary ID [1] 282409 0
Nil
Universal Trial Number (UTN)
U1111-1142-4352
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 288991 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289332 289332 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard physiotherapy (1.5 hours) and virtual reality(VR) balance games (0.5 hours), 2 sessions per week of for 6 continuous weeks). A group exercise therapy conducted by a physiotherapist. This session comprised of self stretching exercises, strengthening exercises using strap-on weights and therabands, coordination and balance exercises such as standing on a foam and ball passing in multi directions; functional exercises such as sit to stand; and endurance training such as walking.
After this group therapy , the experimental group received 30 minutes of VR balance games in addition to 1.5 hours of standard group exercise therapy. The VR games performed were Balance Bubble using Nintendo® Wii Fit Plus with Balance board and Rally Ball using Xbox 360 Kinect for 15 minutes each. These games were selected as they resembled dynamic balance exercises performed in standard exercise therapy. Participants were allowed a practice session before the first therapy session for familiarisation. A therapy assistant supervised the participants performing the VR games on a one to one basis. Progression was based on the participants’ performance progressing to a more difficult and advanced levels on the Balance Bubble game. Participants who scored a gold medal on the Rally ball game were progressed to Reflex Ridge game on Xbox 360 Kinect.
Intervention code [1] 287043 0
Rehabilitation
Intervention code [2] 287044 0
Other interventions
Intervention code [3] 287045 0
Lifestyle
Comparator / control treatment
Standard physiotherapy (2 hours per session , 2 sessions per week of for 6 continuous weeks) received group exercise therapy conducted by a physiotherapist. This session comprised of self stretching exercises, strengthening exercises using strap-on weights and therabands, coordination and balance exercises such as standing on a foam and ball passing in multi directions; functional exercises such as sit to stand; and endurance training such as walking.
Control group
Active

Outcomes
Primary outcome [1] 289448 0
Activities of Daily living using Barthel Index Score
Timepoint [1] 289448 0
Within a week before the start of intervention and within a week after intervention completion.
Primary outcome [2] 289449 0
Gait speed using Timed 10 Meter Walk Test
Timepoint [2] 289449 0
Within a week before the start of intervention and within a week after intervention completion.
Primary outcome [3] 289451 0
lower limb strength using Time Up and Go test
Timepoint [3] 289451 0
Within a week before the start of intervention and within a week after intervention completion.
Secondary outcome [1] 302501 0
Physiological changes . Blood pressure and heart rate were measured using a Digital BP set (Omron, Healthcare Europe B.V).
Timepoint [1] 302501 0
Within a week before the start of intervention and within a week after intervention completion.

Eligibility
Key inclusion criteria
Stroke survivors (at least six months post stroke),
aged 55 and above,
walking independently with or without a walking aid and able to stand for at least 30 minutes .
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe cognitive impairments (Mini Mental State Examination score less than 17),
taking any prescribed drugs that could potentially affect physical function and balance (such as corticosteroids, antipsychotic orantidepressants),
having any medical illness that limit participation in intensive exercise programs.

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)
Participants were screened for inclusion and exclusion criteria from 2 Stroke community rehabilitation centers (Center A and B). All participants who met the criteria were enrolled in the study after they provided consent to participate. The participants from one center (A) received standard physiotherapy and VR balance games. Participants from the other center (B) received only standard physiotherapy.
Methods used to generate the sequence in which subjects will be randomised (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
Sample size was calculated using G power statistical software version 3.1.2, mean difference between 2 groups and one way anova, effect size 0.8 and significant level of 0.05.
Split plot ANOVA was performed with time and group as the within and between subject variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
4/06/2012
Date of last participant enrolment
Anticipated
29/06/2012
Actual
29/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment outside Australia
Country [1] 5050 0
Malaysia
State/province [1] 5050 0
Wilayah Persekutuan

Funding & Sponsors
Funding source category [1] 287182 0
University
Name [1] 287182 0
Grant from Universiti Kebangsaan Malaysia (UKM-KOMUNITI -004-2011).
Country [1] 287182 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Fakulti Sains Kesihatan, Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Country
Malaysia
Secondary sponsor category [1] 285946 0
None
Name [1] 285946 0
Address [1] 285946 0
Country [1] 285946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289178 0
Research and Ethics Committee of Universiti Kebangsaan Malaysia
Ethics committee address [1] 289178 0
Ethics committee country [1] 289178 0
Malaysia
Date submitted for ethics approval [1] 289178 0
Approval date [1] 289178 0
27/05/2012
Ethics approval number [1] 289178 0
UKM 1.5.3.5/244/NN-038-2012

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

Contacts
Principal investigator
Name 39618 0
Dr Devinder Kaur Ajit Singh
Address 39618 0
Program Fisioterapi, Pusat Pengajian Sains Rehabilitasi,
Tingkat 5, Bangunan Yayasan Selangor.
Fakulti Sains Kesihatan, Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Country 39618 0
Malaysia
Phone 39618 0
+603-2687 8003/8025
Fax 39618 0
+603-2687 8199
Email 39618 0
[email protected]
Contact person for public queries
Name 39619 0
Devinder Kaur Ajit Singh
Address 39619 0
Program Fisioterapi, Pusat Pengajian Sains Rehabilitasi,
Tingkat 5, Bangunan Yayasan Selangor.
Fakulti Sains Kesihatan, Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Country 39619 0
Malaysia
Phone 39619 0
+603-2687 8003/8025
Fax 39619 0
+603-2687 8199
Email 39619 0
[email protected]
Contact person for scientific queries
Name 39620 0
Devinder Kaur Ajit Singh
Address 39620 0
Program Fisioterapi, Pusat Pengajian Sains Rehabilitasi,
Tingkat 5, Bangunan Yayasan Selangor.
Fakulti Sains Kesihatan, Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Country 39620 0
Malaysia
Phone 39620 0
+603-2687 8003/8025
Fax 39620 0
+603-2687 8199
Email 39620 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
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Documents added automatically
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