Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001280291
Ethics application status
Approved
Date submitted
24/07/2018
Date registered
30/07/2018
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect Of A Virtual Reality-Based Therapy On Functions In Older Adult With Knee Osteoarthritis
Scientific title
The Effect Of A Virtual Reality-Based Therapy On Functions In Older Adult With Knee Osteoarthritis
Secondary ID [1] 295634 0
Nil known
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 308969 0
Condition category
Condition code
Musculoskeletal 307867 307867 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) the mode of administration of experimental group: face-to-face in a groups of 2
b) the experimental group will perform 35-minute virtual reality-based therapy using Xbox Microsoft® 360 Kinect which consisted of 6 games:
i) 20-minute strength training which consisted of Microsoft Kinect Sports® Soccer for quadriceps strengthening exercise (5-minute), Microsoft Kinect Sports® Athletic for iliopsoas strengthening exercise (5-minute), Microsoft Kinect Adventures® 20,000 leaks for gastrocnemius/soleus strengthening exercise (5-minute), and Microsoft Kinect Adventures® Reflex ridge for squat exercise (5-minute)
ii) Microsoft Kinect Adventures® River Rush for proprioceptive exercise (5-minute)
iii) Microsoft Kinect Sports® Boxing for aerobic exercise (10-minute)
It will be continued twice a week for a duration of 12-week
c) This therapy will be monitored by researcher (who are physiotherapist with 10 years' experience) in the physiotherapy gymnasium
Intervention code [1] 301949 0
Rehabilitation
Intervention code [2] 301952 0
Treatment: Other
Comparator / control treatment
a) the mode of administration of control group: face-to-face in a groups of 5
b) the control group will perform 35-minute conventional physiotherapy exercises which as been recommended by Malaysian Technical Committee of Physiotherapy Profession which consisted of 6 exercises :
i) 20-minute strength training which consisted of quadricep strengthening exercise (5-minute), iliopsoas strengthening exercise (5-minute), gastrocnemius/soleus strengthening exercise (5-minute) and squat exercise (5-minute)
ii) a proprioceptive exercise (5-minute)
iii) a aerobic exercise (10-minute)
It will be continued twice a week for a duration of 12-week
c) This therapy will be monitored by physiotherapist with 5 years' experience in the physiotherapy gymnasium
Control group
Active

Outcomes
Primary outcome [1] 306842 0
Lower limb strength as assessed by 30-second Chair Stand test (Total number of complete chair stands)
Timepoint [1] 306842 0
Baseline and 12 weeks after intervention commencement
Primary outcome [2] 306843 0
Functional stability as assessed by Timed Up and Go test (Time taken from standing up, walking 3-metre and return back to sitting)
Timepoint [2] 306843 0
Baseline and 12 weeks after intervention commencement
Primary outcome [3] 306844 0
Aerobic capacity as assessed by 6-Minute Walk test (Distance covered within 6-minute walking)
Timepoint [3] 306844 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [1] 349901 0
Nil known
Timepoint [1] 349901 0
Nil known

Eligibility
Key inclusion criteria
Older adults who are clinically diagnosed with degenerative knee OA and physically healthy without impairments, functional limitation or disability based on Nagi’s concepts will be enrolled in this study.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Older adults who have systemic arthritis, conditions other than degenerative OA, undergoing Physiotherapy intervention or orthopaedic surgery on the hips, knees or ankles in the previous 12 months, or received Synvisc or intra-articular steroid injections in the previous 6 months will be excluded from this study.

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)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocked randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been calculated using G*Power 3.1.9.2 software through F tests with ANOVA: Repeated measures, between group. By maintaining a large effect size, Cohen f=0.4, the sample number estimated for this study was 20 participants per group (Power of 0.812). In order to prevent sample loss by the end of the study, 22 participants will be admitted in each group. Thus, 44 participants will be recruited in this study.
To analyze the intervention effect statistically, Mixed Model ANOVA will be used to compare the time effects, group effects and interaction effects between both groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
1/03/2018
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
44
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 10677 0
Malaysia
State/province [1] 10677 0
Melaka

Funding & Sponsors
Funding source category [1] 300218 0
Government body
Name [1] 300218 0
Ministry of Health Malaysia
Country [1] 300218 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz,Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 299627 0
Government body
Name [1] 299627 0
Ministry of Health Malaysia
Address [1] 299627 0
Medical Research and Ethics Committee (MREC)
Ministry of Health Malaysia
NIH Secretariat
d/a Institut Pengurusan Kesihatan
Jalan Rumah Sakit, Bangsar
59000 Kuala Lumpur
Country [1] 299627 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301039 0
Faculty of Health Sciences, Universiti Kebangsaan Malaysia
Ethics committee address [1] 301039 0
Ethics committee country [1] 301039 0
Malaysia
Date submitted for ethics approval [1] 301039 0
23/01/2017
Approval date [1] 301039 0
10/07/2017
Ethics approval number [1] 301039 0
NN-2017-123
Ethics committee name [2] 301046 0
Medical Research & Ethics Committe, Malaysian Ministry of Health
Ethics committee address [2] 301046 0
Ethics committee country [2] 301046 0
Malaysia
Date submitted for ethics approval [2] 301046 0
06/02/2017
Approval date [2] 301046 0
01/11/2017
Ethics approval number [2] 301046 0
NMRR-17-1785-36812 (IIR)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2908 2908 0 0
/AnzctrAttachments/375654-ETHICS APPROVAL UKM & KKM.pdf (Ethics approval)

Contacts
Principal investigator
Name 85674 0
Mr Mohd Naqiuddin Johar
Address 85674 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country 85674 0
Malaysia
Phone 85674 0
+60-3-26878038
Fax 85674 0
+60-3-26878199
Email 85674 0
[email protected]
Contact person for public queries
Name 85675 0
Mohd Naqiuddin Johar
Address 85675 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country 85675 0
Malaysia
Phone 85675 0
+60-3-26878038
Fax 85675 0
+60-3-26878199
Email 85675 0
[email protected]
Contact person for scientific queries
Name 85676 0
Nor Azlin Mohd Nordin
Address 85676 0
Physiotherapy Programme, Center for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300 Kuala Lumpur, Malaysia
Country 85676 0
Malaysia
Phone 85676 0
+60-3-26878038
Fax 85676 0
+60-3-26878199
Email 85676 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.