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Trial registered on ANZCTR

Registration number

ACTRN12616000051448

Ethics application status

Approved

Date submitted

14/01/2016

Date registered

20/01/2016

Date last updated

30/01/2020

Date data sharing statement initially provided

30/01/2020

Date results provided

30/01/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Can an activity monitor and smart device application improve the intensity of therapy after stroke?

Scientific title

Can an activity monitor and smart device application improve the intensity of therapy after stroke? - a feasibility study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

INTERAct

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Sit to stand is a common functional exercise prescribed by physiotherapists. The intervention in this study involves completing a set number of a sit to stand exercise per day which will be monitored with a device connected to an app. The app will providing feedback to the patient and enable the therapist to see the number of sit to stands performed by the patients remotely. The therapist will also be able to change the number of sit to stand goal remotely via a function on the application.
Participants will be instructed in their home on how to use the sit to stand activity monitor (AM) and smart device application (on participants own iPhone, iPad or project provided tablet). The AM consists of a small pressure sensor which is placed under a nominated chair in the participant’s home. Participants will use the AM for the 5-week study period and track their number of daily sit to stand repetitions. At the start of weeks 2-5 the research therapist will review the participant’s results remotely via the internet and set a target for the participant for the following week based on the number of sit to stands performed each day in the preceding week. The weeks goal will be programmed remotely into the smart device application (and phone call if necessary). Participants will connect to the smart device application to get feedback on how close they are to their goal or whether they have achieved the day’s target. Results will be available to the research therapist remotely.

Intervention code [1]

Rehabilitation

Comparator / control treatment

No Control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Adherence to set program (number of sit to stands in weeks 2-5 measured by the activity monitor / set target on the smart device application).

Timepoint [1]

Weeks 2 - 5

Primary outcome [2]

Usability and acceptability of activity monitor & smart device app: System usability scale

Timepoint [2]

End of week 5

Secondary outcome [1]

Helpfulness and enjoyment of activity monitor and app: Physical activity enjoyment scale

Timepoint [1]

End week 5

Secondary outcome [2]

Ease of delivering the exercise upgrades remote via internet connected smart device: System usability scale (therapist)

Timepoint [2]

End of week 5

Secondary outcome [3]

Number of sit to stands in 2 minutes; Short Physical Performance Battery (sit to stand, balance, gait)

Timepoint [3]

Baseline and end of week 5

Eligibility

Key inclusion criteria

1) 12 months or less post diagnosis of stroke 2) Living in the community 3) Age >=18 years 4) Able to perform sit to stand independently

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Living in a nursing home 2) Unable to follow instructions sufficiently to participate in the intervention 3) Medically unstable

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

feasibility study

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Adherence will be described as percentage equal to the number performed/target. Participant perceptions (primary outcomes 2 and 3) of the technology will be described using frequency counts and percentages for each likert scale from the questionnaires. Changes in secondary outcome measures will be performed using t-tests or non-parametric tests to compare normally and non-normally distributed data respectively.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2016

Actual

1/02/2016

Date of last participant enrolment

Anticipated

31/07/2017

Actual

4/09/2017

Date of last data collection

Anticipated

4/09/2017

Actual

9/10/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment postcode(s) [1]

7000 - Hobart

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Hobart Hospital Research Foundation

Address [1]

BUPA Building Ground Floor 25 Argyle Street Hobart Tasmania 7001

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Michele Callisaya

Address

Menzies Institute of Medical Research
17 Liverpool Street,
Hobart Tasmania
7000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

Individual

Name [1]

Prof Stuart Smith

Address [1]

University of the Sunshine Coast & Sunshine Coast Inc, PO Box 596, Maroochydore QLD 4558

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Matthew Schmidt

Address [2]

University of Tasmania 17 Liverpool Street Hobart Tasmania 7000

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Miss Dawn Simpson

Address [3]

Menzies Institute of Medical Research 17 Liverpool Street Hobart Tasmania 7000

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr Marie-Louise Bird

Address [4]

University of Tasmania Newnham Campus University of Tasmania Locked Bag 1362 Launceston Tasmania 7250

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (Tasmania)

Ethics committee address [1]

Office of Research Services
University of Tasmania
Private bag 1
Hobart 
Tasmania
7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/05/2015

Approval date [1]

25/06/2015

Ethics approval number [1]

H0014859

Summary

Brief summary

Current stroke guidelines recommend as much physical practice as possible in the first 6 months after stroke.  A number of recent reviews concluded that therapy should include intensive repetitive task training to improve functional outcomes (such as the ability to transfer and walk).
However, a number of factors can lead to patients remaining inactive, particularly once home.  
1)	Limitations of outpatient therapy: Frequency of appointments is low and programs are time limited in duration. 
2)	Motivation and confidence: Low motivation and lack of a therapist monitoring practice can contribute to poor adherence to exercise. Providing accurate feedback, goal setting and rewards can enhance compliance and self efficacy.
3)	Geographical location: Patients may live in remote or rural areas resulting in less access to specialist rehabilitation services or have limited access to transport to attend therapy. 
Novel, cost-effective and enjoyable ways are needed to increase the intensity of practice outside of centre-based therapy. 
Therefore, the purpose of this study is to investigate whether for people who have had a stroke:
1. a smart device application and activity monitor (AM) can be used to increase repetitions of a functional exercise outside of centre-based therapy
2. the activity monitor and smart device application package is enjoyable, acceptable and easy to use.
3. progression of intensity of practice can be delivered remotely by a therapist via the internet.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michele Callisaya

Address

Menzies Institute of Medical Research Private Bag 23 Hobart Tasmania 7001

Country

Australia

Phone

+61 418295933

Fax

[email protected]

Contact person for public queries

Name

Michele Callisaya

Address

Menzies Institute of Medical Research Private Bag 23 Hobart Tasmania 7001

Country

Australia

Phone

+61 418295933

Fax

[email protected]

Contact person for scientific queries

Name

Michele Callisaya

Address

Menzies Institute of Medical Research Private Bag 23 Hobart Tasmania 7001

Country

Australia

Phone

+61 418295933

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• all de-identified individual participant data

What types of analyses could be done with individual participant data?

• Those that meet the aims of the approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
from now for 5 years

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Request to CI and via signing a data sharing agreement

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically