Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001108303
Ethics application status
Approved
Date submitted
25/07/2017
Date registered
28/07/2017
Date last updated
17/04/2019
Date data sharing statement initially provided
17/04/2019
Date results information initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exergaming to improve balance and decrease the risk
of falling in adults with knee osteoarthritis: a feasibility study
Scientific title
Implementation of an exergaming intervention to improve balance and reduce the risk of falling in individuals with knee osteoarthritis: a feasibility study
Secondary ID [1] 292517 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 304160 0
Condition category
Condition code
Musculoskeletal 303522 303522 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 303523 303523 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, the Nintendo Wii Fit™ games and balance board system will be utilised as an exergaming intervention. A trained physiotherapist will conduct the balance exergaming in a set-up exergaming room at the School of Physiotherapy.

The balance board which measures 8.5’’ x 6’’ x 2’’ is an accessory for the Nintendo’s Wii video game console. It has a white top and a grey bottom, shaped like a weighing scale. The balance board is a wireless console that can support up to 300 lbs. The balance board contains several multiple pressure sensors that measure a player’s centre of balance and the body mass index (BMI). The balance board will be calibrated before the commencement of the study.

Participants will perform balance exercise for 45 to 60 minute, three times per week for an eight-week period. The games will include Table Tilt, Soccer Heading and Penguin Slide. These games were chosen due to their focus on weight shifting which is a component of postural balance. To monitor adherence, participants will be followed-up through phone calls.
Intervention code [1] 298703 0
Rehabilitation
Intervention code [2] 298733 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302895 0
Feasibility outcome:
Recruitment- the number of participants recruited in three months
Timepoint [1] 302895 0
From baseline to (16 week) post intervention
Primary outcome [2] 302907 0
Feasibility outcome:
Retention: number of participants retained post-intervention
Timepoint [2] 302907 0
Baseline to (16 week) post intervention
Primary outcome [3] 302908 0
Feasibility outcome:
Compliance - (attendance) number of days per week performed the intervention
Timepoint [3] 302908 0
Baseline to 16 week post intervention
Secondary outcome [1] 337402 0
(Primary)
Feasibility outcome:
Safety - number of adverse events/harm related to the study or intervention
Timepoint [1] 337402 0
Baseline to 16 week post intervention
Secondary outcome [2] 337403 0
(Primary)
Balance - Sensory Organisation Test using NeuroCom SMART Equitest system, version 8.6.0
Timepoint [2] 337403 0
Baseline, 8th week and 16th week
Secondary outcome [3] 337404 0
(Primary)
Falls risk - Physiological Profile Assessment
Timepoint [3] 337404 0
Baseline, 8th week and 16th week
Secondary outcome [4] 337405 0
Pain - Knee injury and Osteoarthritis Outcome Score
Timepoint [4] 337405 0
Baseline, 8th week, 16th week
Secondary outcome [5] 337406 0
Stiffness - Knee injury and Osteoarthritis Outcome Score
Timepoint [5] 337406 0
Baseline, 8th week, 16th week
Secondary outcome [6] 337407 0
Daily function - Knee injury and Osteoarthritis Outcome Score
Timepoint [6] 337407 0
Baseline, 8th week, 16th week
Secondary outcome [7] 337408 0
Knee related quality of life - Knee injury and Osteoarthritis Outcome Score
Timepoint [7] 337408 0
Baseline, 8th week, 16th week
Secondary outcome [8] 337409 0
Knee Instability - Knee Outcome Survey – Activities of Daily Living Scale
Timepoint [8] 337409 0
Baseline, 8th week, 16th week
Secondary outcome [9] 337410 0
Knee muscle strength - Hand-held dynamometer using Nicholas MMT, Model 01160
Timepoint [9] 337410 0
Baseline, 8th week, 16th week
Secondary outcome [10] 337411 0
Physical function - Timed Up and Go Test (TUG)
Timepoint [10] 337411 0
Baseline, 8th week, 16th week
Secondary outcome [11] 337412 0
Fear of falling - Short Fall Efficacy Score – International
Timepoint [11] 337412 0
Baseline, 8th week, 16th week
Secondary outcome [12] 337413 0
Perceptions and experiences - Semi-structured interview
Timepoint [12] 337413 0
Post intervention

Eligibility
Key inclusion criteria
Participants with knee osteoarthritis meeting the clinical criteria of the American College of Rheumatology and history of falls over the past 12 months will be recruited. A fall is defined as an event in which person unintentionally comes to rest on the ground or other lower level.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include the presence of another concomitant lower extremity musculoskeletal condition, inflammatory arthritis, the presence of neurological diseases, previous history of lower limb joint replacement, the presence of cognitive deficits, and those with a vestibular problem. A participant who is receiving the current intervention or included in an ongoing study as well as with previous history of using exergaming will also be excluded.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A mixed-methods, explanatory sequential study design will be conducted for piloting the Nintendo Wii Fit™ exergaming program in individuals with knee OA. This design emphasises quantitative analysis, which is followed by interviews or observations (qualitative) to help in analysing the findings. The quantitative part will be a one-way repeated measures design, while the qualitative part will be a focus group discussion.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2017
Actual
1/11/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
1/12/2017
Date of last data collection
Anticipated
15/03/2018
Actual
23/03/2018
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 9086 0
New Zealand
State/province [1] 9086 0
Otago

Funding & Sponsors
Funding source category [1] 297088 0
University
Name [1] 297088 0
University of Otago, School of Physiotherapy
Country [1] 297088 0
New Zealand
Primary sponsor type
University
Name
University of Otago, School of Physiotherapy
Address
325 Great King Street Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 296096 0
None
Name [1] 296096 0
Address [1] 296096 0
Country [1] 296096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298266 0
Health and Disability Ethics Committees - New Zealand
Ethics committee address [1] 298266 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 298266 0
New Zealand
Date submitted for ethics approval [1] 298266 0
31/08/2017
Approval date [1] 298266 0
24/10/2017
Ethics approval number [1] 298266 0
17/STH/184

Summary
Brief summary
There is evidence of increasing number of falls in adults with knee osteoarthritis (OA). The increased risk of falling in individuals with knee OA may be due to balance impairment and disease-related symptoms. Exercise is recommended as one of the first lines of choice in the conservative management of knee OA. Doing exercise in a supervised group, practising Tai Chi, and participating in physical activities such as walking has been proven effective; however, there are alternative treatments that can be used that may provide possible therapeutic and rehabilitative effect in a novel and engaging way such as exergaming (exercise + gaming). The majority of published articles investigating the use of exergaming included healthy and patient population where the latter are mostly neurologic conditions such Stroke, Parkinson’s disease, and Multiple Sclerosis. Several exergames have been developed to increase physical fitness and balance, yet it is also unclear to which degree of usability, safety and acceptability of this exergaming programme in a knee OA group. This research aims to conduct an exergaming intervention using Nintendo Wii Fit™ games in individuals with knee osteoarthritis. The primary objective is to determine the feasibility of implementing an exergaming balance intervention. Also, the study aims to estimate changes in the outcome measure scores mainly for balance and risk of falling. Participants with knee osteoarthritis and history of falling will be recruited from Dunedin through community advertising. Individuals with knee OA and history of falling will be recruited following a set of inclusion and exclusion criteria. Recruitment will be from September 2017 to Dec 2017. Eligible participants will participate in 16-week study programme: eight weeks of usual care and three times per week of exergaming for eight weeks. Participants will also have to attend three assessment sessions (baseline, eighth-week, and 16th-week). A focus group discussion will be conducted after the intervention to explore participant's perceptions and experiences. During the assessment, participants will be asked to answer some questionnaire, survey, and perform standard tests for balance, strength and physical function. All the assessment and intervention sessions will be done at the Balance Clinic of School of Physiotherapy and in a set-up exergaming room, respectively. The duration of both assessment and intervention will be approximately 60 minutes. The proposed project will be an essential preliminary step towards investigating the usability of Wii Fit™ exergaming as a balance intervention and as part of a fall prevention program for individuals with knee OA. Findings from this study will inform the design of the future intervention protocol and explore the acceptability of the exergaming intervention in this patient population.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1916 1916 0 0
/AnzctrAttachments/373367(v27-07-2017-14-18-29)-Protocol 240717.docx (Protocol)

Contacts
Principal investigator
Name 76526 0
Mr Donald Manlapaz
Address 76526 0
325 Great King Street Dunedin 9016
School of Physiotherapy
University of Otago
Country 76526 0
New Zealand
Phone 76526 0
+64 3 4795422
Fax 76526 0
Email 76526 0
[email protected]
Contact person for public queries
Name 76527 0
Mr Donald Manlapaz
Address 76527 0
325 Great King Street Dunedin 9016
School of Physiotherapy
University of Otago
Country 76527 0
New Zealand
Phone 76527 0
+64 3 4795422
Fax 76527 0
Email 76527 0
[email protected]
Contact person for scientific queries
Name 76528 0
Mr Donald Manlapaz
Address 76528 0
325 Great King Street Dunedin 9016
School of Physiotherapy
University of Otago
Country 76528 0
New Zealand
Phone 76528 0
+64 3 4795422
Fax 76528 0
Email 76528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.