ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Parkinson's disease

Condition category

Condition code

Neurological

Parkinson's disease

Physical Medicine / Rehabilitation

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]

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]

Nine hole peg test (assessing upper limb and hand function)

Timepoint [1]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [1]

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]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [2]

Coin rotation test (assessing finger dexterity)

Timepoint [2]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [3]

Box and block test (assessing upper limb dexterity)

Timepoint [3]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [4]

Hand reaction time test

Timepoint [4]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [5]

Manual Ability Measure - 36

Timepoint [5]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [6]

Parkinson's Disease Questionnaire - 39

Timepoint [6]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [7]

Trail making tests A and B (assessing cognition)

Timepoint [7]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [8]

Montreal Cognitive Assessment

Timepoint [8]

At baseline and one week after completion of the 12 week intervention

Secondary outcome [9]

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]

One week after completion of the 12 week intervention

Secondary outcome [10]

Performance and adherence measures recorded by the videogame system

Timepoint [10]

Over twelve weeks of intervention

Secondary outcome [11]

Acceptability of the intervention, where participants complete a questionnaire designed specifically for this study regarding their experience of undertaking the intervention

Timepoint [11]

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]

Charities/Societies/Foundations

Name [1]

Parkinson's NSW

Address [1]

PO Box 71
North Ryde BC NSW 1670

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Sydney Bridging Support Grant

Address [2]

Research Grants and Contracts
Level 6, G02
Jane Foss Russell Building
University of Sydney NSW 2006

Country [2]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Level 6, Jane Foss Russell
The University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/07/2014

Ethics approval number [1]

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

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

Phone

+61 415 300 337

Fax

Email

[email protected]

Contact person for public queries

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

Phone

+61 415 300 337

Fax

Email

[email protected]

Contact person for scientific queries

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

Phone

+61 415 300 337

Fax

Email

[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.	Type	Citation	Link	Email	Other Details	Attachment
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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference abstract	No		95. Schmidt M, Paul S, Song J, O’Duffy J, Smith S,... [More Details]
Study results article	Yes		17. Allen NE, Song J, Paul SS, Smith S, O’Duffy J,... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The accuracy of self-report logbooks of adherence to prescribed home-based exercise in Parkinson's disease.	2022	https://dx.doi.org/10.1080/09638288.2020.1800106

N.B. These documents automatically identified may not have been verified by the study sponsor.