Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001048673
Ethics application status
Approved
Date submitted
25/09/2014
Date registered
1/10/2014
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Date results information initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Active Arms in Parkinson's disease: effect of an interactive videogame on arm and hand function
Scientific title
ActiveArms: A randomised controlled trial of an interactive videogame compared to usual care on arm and hand function in people with Parkinson’s disease
Secondary ID [1] 285393 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 293130 0
Condition category
Condition code
Neurological 293398 293398 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 293399 293399 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Home-based upper limb training using interactive videogames 3 times per week for 12 weeks. Participants will perform 20 minutes of exercise per session. The exercises will be performed with one arm, then repeated with the other arm (one arm at a time). Participants will make either rapid whole arm movements or finger movements to a target location in response to randomly presented visual cues. The speed and timing of the visual stimuli will be modified to increase difficulty of the games. Participants will receive 2 initial home visits from the physiotherapist to set up the videogame system and to learn how to use it safely. Regular telephone calls and an additional home visit (week 6) will be provided to monitor and progress exercises. A final home visit will take place on completion of the 12-week program. Participants will be provided with all equipment for the 12-week training program, as well as a booklet containing instructions and safety precautions.
Intervention code [1] 290307 0
Rehabilitation
Comparator / control treatment
Participants will receive usual care and will be instructed to continue with their usual activities. Specifically, usual care includes any routine medical, nursing or allied health care. Usual care activities include any regular physical activities undertaken by participants on entry to the study, such as regular walks, exercise sessions and hobbies requiring use of the arms.
Control group
Active

Outcomes
Primary outcome [1] 293228 0
Nine hole peg test (assessing upper limb and hand function)
Timepoint [1] 293228 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [1] 310630 0
Horizontal and vertical tapping test using alternate tapping of keys on a keyboard (assessing movement speed and accuracy), performed with and without a concurrent cognitive task (counting backwards by threes from a randomly allocated number between 50 and 100).
Timepoint [1] 310630 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [2] 310631 0
Coin rotation test (assessing finger dexterity)
Timepoint [2] 310631 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [3] 310632 0
Box and block test (assessing upper limb dexterity)
Timepoint [3] 310632 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [4] 310633 0
Hand reaction time test
Timepoint [4] 310633 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [5] 310634 0
Manual Ability Measure - 36
Timepoint [5] 310634 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [6] 310635 0
Parkinson's Disease Questionnaire - 39
Timepoint [6] 310635 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [7] 310636 0
Trail making tests A and B (assessing cognition)
Timepoint [7] 310636 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [8] 310637 0
Montreal Cognitive Assessment
Timepoint [8] 310637 0
At baseline and one week after completion of the 12 week intervention
Secondary outcome [9] 310638 0
Global perceived effect of the participant's perception of the effect of the intervention on their arm and hand function using a standard 11-point scale
Timepoint [9] 310638 0
One week after completion of the 12 week intervention
Secondary outcome [10] 310639 0
Performance and adherence measures recorded by the videogame system
Timepoint [10] 310639 0
Over twelve weeks of intervention
Secondary outcome [11] 310640 0
Acceptability of the intervention, where participants complete a questionnaire designed specifically for this study regarding their experience of undertaking the intervention
Timepoint [11] 310640 0
One week after completion of the 12 week intervention

Eligibility
Key inclusion criteria
Idiopathic Parkinson's disease
Living in the community (Greater Sydney Metropolitan area)
Stable PD medications for at least 2 weeks prior to baseline assessment
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mini-mental State Examination Score less than 24/30
Any unstable cardiovascular, orthopaedic or neurological conditions that would preclude or interfere with physical assessment or the training protocol.

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)
After baseline assessment, participants will be stratified according to upper limb disease severity, then allocated randomly to the intervention or the control group. Stratification will be based on upper limb disease severity, as determined by the total score of the 6 upper limb items of the motor section of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) (ie, Item 3.4 Finger tapping, Item 3.5 Hand Movements, Item 3.6 Pronation-supination movements of the hands, Item 3.15 Postural tremor of the hands, Item 3.16 Kinetic tremor of the hands, Item 3.7 Rest tremor amplitude of the hands). The total possible score for these 6 items is 0-48, where 0 reflects no tremor or symptoms affecting the upper limbs. Stratification will be based on this total score (0-12 vs =>13). Allocation will be concealed as randomisation will be performed off-site by an investigator not involved in participant recruitment using block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using Excel’s rand function.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between-group comparisons of final test performance for the continuously-scored outcome measures will be made using General Linear Models (ANCOVA) controlled for pre-test performance. An intention-to-treat approach will be used. Calculations of statistical power based on nine hole peg test measures in people with PD suggest 38 participants (19 per group) will be sufficient to detect a 20% between-group difference (mean 29.9 seconds, SD 10.2) in the nine hole peg test time (power=0.8, alpha=0.05, pre/post correlation=0.8, 10% dropouts).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2014
Actual
14/10/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
28/10/2015
Date of last data collection
Anticipated
Actual
27/01/2016
Sample size
Target
38
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289998 0
Charities/Societies/Foundations
Name [1] 289998 0
Parkinson's NSW
Country [1] 289998 0
Australia
Funding source category [2] 289999 0
University
Name [2] 289999 0
University of Sydney Bridging Support Grant
Country [2] 289999 0
Australia
Primary sponsor type
Individual
Name
A/Prof Colleen Canning
Address
Clinical and Rehabilitation Sciences Research Group
Faculty of Health Sciences
The University of Sydney
PO Box 170 Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 288683 0
None
Name [1] 288683 0
none
Address [1] 288683 0
none
Country [1] 288683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291707 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 291707 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Ethics committee country [1] 291707 0
Australia
Date submitted for ethics approval [1] 291707 0
Approval date [1] 291707 0
24/07/2014
Ethics approval number [1] 291707 0
2014/325

Summary
Brief summary
There is an expanding evidence-base demonstrating benefits of exercise for improving balance and mobility in people with Parkinson’s disease. Yet the role of exercise in improving arm and hand function has been neglected to date. The primary aim of this randomised controlled trial is to determine the impact of a home-based, interactive videogame system designed for people with Parkinson’s disease on upper limb function. The secondary aims are to determine the effect on finger and upper limb dexterity, performance of upper limb tasks, quality of life, and cognition. In addition, the participants’ perception of the effect of the intervention and acceptability of the intervention will be evaluated. Since difficulty performing upper limb activities is associated with poor quality of life, the development of effective, sustainable and engaging exercise programs to improve upper limb function in people with Parkinson’s disease is an urgent research priority.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51654 0
A/Prof Colleen Canning
Address 51654 0
Clinical and Rehabilitation Sciences Research Group
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 51654 0
Australia
Phone 51654 0
+61 415 300 337
Fax 51654 0
Email 51654 0
[email protected]
Contact person for public queries
Name 51655 0
Colleen Canning
Address 51655 0
Clinical and Rehabilitation Sciences Research Group
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 51655 0
Australia
Phone 51655 0
+61 415 300 337
Fax 51655 0
Email 51655 0
[email protected]
Contact person for scientific queries
Name 51656 0
Colleen Canning
Address 51656 0
Clinical and Rehabilitation Sciences Research Group
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 51656 0
Australia
Phone 51656 0
+61 415 300 337
Fax 51656 0
Email 51656 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6032     100. Allen N, Song J, Paul S, Smith S, O’Duffy J, ... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo 95. Schmidt M, Paul S, Song J, O’Duffy J, Smith S,... [More Details]
Study results articleYes 17. Allen NE, Song J, Paul SS, Smith S, O’Duffy J,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe accuracy of self-report logbooks of adherence to prescribed home-based exercise in Parkinson's disease.2022https://dx.doi.org/10.1080/09638288.2020.1800106
N.B. These documents automatically identified may not have been verified by the study sponsor.