ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000743460

Ethics application status

Approved

Date submitted

16/05/2016

Date registered

6/06/2016

Date last updated

17/02/2022

Date data sharing statement initially provided

17/02/2022

Date results information initially provided

17/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Does Physitrack 'Registered Trademark' improve participation in exercise programmes in children with cerebral palsy?

Scientific title

Evaluating the effectiveness of home exercise programmes using an online exercise prescription tool in children with cerebral palsy: a randomised controlled trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1182-8632

Trial acronym

Linked study record

Health condition

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

Cerebral Palsy

Physical Disablity

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention being trialled is a home exercise programme delivered using Physitrack 'Registered Trademark'. Physitrack 'Registered Trademark' is an online, app-based exercise programme platform, designed to improve exercise participation with features including: professional videos of over 2000 exercises, audio transcripts of spoken instructions for each exercise, customisable dosage parameter) (eg hold times, repetitions, sets), a calendar to select exercise days, and capacity for the user to provide feedback online and the therapist to respond. In addition, Physitrack 'Registered Trademark' provides a therapist working in the community- using a smartphone or tablet device- with the ability to custom-make exercise videos of the child or caregiver, to be included in their home programme.

Prior to the 8-week intervention period of this study, the participants' primary treating community physiotherapist will arrange two, 1 hour, home visit appointments for the participants: both the child and their parent to attend. The community physiotherapists are registered physiotherapists employed in Western Australian in community physiotherapy services and private physiotherapy practices, of varying levels of experience, who have responded to the invitation to participate. They will be trained in using Physitrack 'Registered Trademark' via a 60min webinar conducted by the Programme Director at Physitrack, and asked to practice using Physitrack prior to the data collection period.

The first home visit that these physiotherapists schedule with the participants, is to determine specific goals for the exercise programme and to trial exercises for the programme. The exercise programme is individualised by the physiotherapist for each participant, based on agreed goals and their ability to perform essential elements of the exercises that were trialled at the first appointment. Some examples of common exercises in this population includes, but is not limited to: gastrocnemius standing stretch, sitting hamstring stretch, heel raises, bridging exercise, wall squats, plank exercise, wall push-ups, and running and jumping drills. The intensity, duration, and frequency of exercise will be determined individually by the community physiotherapist, as per standard care. At the second appointment the physiotherapist will review the home exercises with the participant and deliver the programme: the treatment group will receive their individualised home programme of exercises delivered with Physitrack 'Registered Trademark'. At this appointment the physiotherapist will explain- verbally and by demonstration on mobile device (smartphone or tablet)- how to use the app or website; and go through each selected exercise on the app. After this second appointment the family will then be left to continue the exercise programme at home using Physitrack website or the Physitrack 'Registered Trademark' app for Apple or Android devices.

During the 8 week intervention period, the community physiotherapist will follow-up on the participant's exercise programme according to their usual practice which incorporates the preferences of the family, as in a family-centred practice model. This may be regular appointments; one or several follow-up appointments; one or several phone calls or emails;, or no follow-up at all. This follow-up will be documented by the primary physiotherapists. Participants will keep a record of which exercises are completed in an exercise log book, which will be provided to them. Participants may seek support with the programme, or specifically with using Physitrack, by contacting their primary treating physiotherapist. If the therapist requires further support themselves, this can be accessed from Physitrack staff by phone call or email.

Intervention code [1]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control group will receive a home exercise programme, without using Physitrack 'Registered Trademark', but delivered using conventional means. For example, but not limited to: hand-written notes, typed document, or a photo programme.

Prior to the 8-week intervention period of this study, the participants' primary treating community physiotherapist will arrange two, 1 hour, home visit appointments for the participants: both the child and their parent to attend. The community physiotherapists are registered physiotherapists employed in Western Australian in community physiotherapy services and private physiotherapy practices, of varying levels of experience, who have responded to the invitation to participate. They will be trained in using Physitrack 'Registered Trademark' via a 60min webinar conducted by the Programme Director at Physitrack, and asked to practice using Physitrack prior to the data collection period.

The first home visit that these physiotherapists schedule with the participants, is to determine specific goals for the exercise programme and to trial exercises for the programme. The exercise programme is individualised by the physiotherapist for each participant, based on agreed goals and their ability to perform essential elements of the exercises that were trialled at the first appointment. Some examples of common exercises in this population includes, but is not limited to: gastrocnemius standing stretch, sitting hamstring stretch, heel raises, bridging exercise, wall squats, plank exercise, wall push-ups, and running and jumping drills. The intensity, duration, and frequency of exercise will be determined individually by the community physiotherapist, as per standard care. At the second appointment the physiotherapist will review the home exercises with the participant and deliver the programme by conventional means. The treating physiotherapist will chose between the conventional means of exercise programme delivery (e.g. hand-written notes, typed document, or photo-programme) on an individual basis, incorporating the preferences of the participant and the therapist. After this second appointment the participants will then be left to implement the exercise programme at home following the document they have been provided with.

During the 8 week intervention period, the community physiotherapist will follow-up on the participant's exercise programme according to their usual practice which incorporates the preferences of the family, as in a family-centred practice model. This may be regular appointments; one or several follow-up appointments; one or several phone calls or emails;, or no follow-up at all. This follow-up will be documented by the primary physiotherapists. Participants will keep a record of which exercises are completed in an exercise log book, which will be provided to them. Families may seek support with the programme at any time, by contacting their primary treating physiotherapist.

At the end of the 8 week exercise program, the participants in the control group will be offered Physitrack 'Registered Trademark', so that all participants will be given the opportunity access this method of exercise programme delivery, if they chose.

Control group

Active

Outcomes

Primary outcome [1]

Exercise adherence recorded through::
A) exercise diary
B) self-rated questionnaire about adherence using 11-point Numeric Rating Scale (NRS)
(composite primary goal)

Timepoint [1]

A) Completed weekly over 8 week intervention period
B) Completed at the end of 8 week intervention period

Primary outcome [2]

Performance and Satisfaction scores, for up to three individualised goals, for each participant, using the Canadian Occupational Performance Measure (COPM) modified for use with children (Cusick, Lannin & Lowe, 2007). A 2 point change in score on the COPM is considered to be clinically meaningful. The proportion of participants in each group that show a 2 point change in COPM score will be compared between the two groups using Chi square or Fishers exact test.

Timepoint [2]

Before and after the 8-week intervention period

Primary outcome [3]

Proportion exercises completed correctly for each participant using the of Correctness of Exercise Performance (COEP) (Friedrich, Cermak & Maderbacher, 1996)

Timepoint [3]

Measured at the beginning, the half-way point, and at the end of the 8 week intervention period.

Secondary outcome [1]

Enjoyment of exercise from the children will be assessed using Physical Activity and Enjoyment Scale (PACES) questionnaire (Moore et al., 2009).

Timepoint [1]

Before and after the 8-week intervention period

Secondary outcome [2]

Satisfaction with the delivery of the exercise program by parents and children will be assessed using an 11-point Numeric Rating Scale (NRS)

Timepoint [2]

The confidence to exercise question will be assessed pre and post the intervention period. The satisfaction and the process measures will be collected at the end of the 8-week intervention period.

Secondary outcome [3]

Physiotherapists and parents in the treatment group will be questioned about the usability of the Physitrack 'registered trademark' using a modified System Usability Scale (SUS) (Bangor, Kortum & Miller, 2008).

Timepoint [3]

At the end of the study.

Secondary outcome [4]

Confidence to exercise from parents and children will be assessed using an 11-point Numeric Rating Scale (NRS)

Timepoint [4]

Before and after the intervention period

Eligibility

Key inclusion criteria

- Diagnosis: Cerebral Palsy or other physical disabilities
- Age: children aged 6 to 17 years
- Family have agreed to having a home exercise programme
- Physiotherapist to determine that the child has the cognitive ability to follow an exercise programme in either written or electronic format; with or without support from their parents.
- Families have access to the internet in their home, and can access Physitrack 'registered trademark': either through the Physitrack website or by downloading the free app- PhysiApp 'registered trademark'- on an Apple or Andriod device- accessible to the child and parent at home.
- Participants and their parents/guardians are fluent in the English language.

Minimum age

6 Years

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Has orthopaedic surgery scheduled during the 8 week study period
- Has another significant medical intervention or inpatient stay which will impair their ability to follow an exercise programme during the study period. (e.g. hospital admission for pneumonia).
- Will not have serial casting intervention scheduled during 8 week study period
- Receiving an intensive intervention service (frequency greater than 2 times per week) during 8 week study period

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)

The potential participants primary treating physiotherapy will seek an expression of interest and determine eligibility into the study. At this point, the primary physio will be blinded to the group allocation. Upon enrolling into the study, the participant will be allocated into a group by he Ability centre Research Coordinator who is independent of the study and holds the allocation schedule. Further to this, the primary physiotherapist will be notified of the group allocation and proceed accordingly.

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

The participants, stratified by a measure of their level of functional mobility (as indicated by a rating of their walking ability for a distance of 50m using the Functional Mobility Scale (FMS) (Graham et.al., 2004)) and also stratified by age (less than 12 years, or 12 years and older), will be randomly assigned to two groups by a research associate (Marie Blackmore, Research Coordinator at Ability Centre) using a computerised random number generator so the principal researchers are blinded to group allocation.

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

This programme has not previously been used with this population. However using the published data from a web delivered intervention that measured adherence (Breitenstein et al. 2016), we estimate that to detect a difference in adherence of 51% in the control and 85% in the treatment group, with at least 80% power and significance level of 0.05, we require a minimum of 29 children per group (58 total), using a 2 tailed test. To allow for 15% attrition, a minimum of 33 per group (66 in total) will be recruited.

Participant characteristic will be described using means and standard deviations for continuous data, median and interquartile ranges for skewed or ordinal data, and frequencies and percentages for categorical data.
Adherence will be measured by three variables (days, number of exercises and number of reps). Adherence will be calculated as a proportion. For example number of exercises completed/number of exercises prescribed. The two groups will be compared using a t test, or the nonparametric equivalence (Mann Whitney U) if required. In addition, as the adherence can be considered as count variables poisson regression will be used with group allocation entered as an independent variable in the regression equation. This will calculate incident rate ratios and their 95% confidence intervals allowing comparison of the rates between the two groups.

The COPM performance and satisfaction scores will be calculated for each participant. The groups will be compared using ANCOVA, with the baseline variable and group entered into the regression equation. This will calculate the mean change from baseline (and their 95% confidence intervals). A 2 point change in score on the COPM is considered to be clinically meaningful. The proportion of participants in each group that show a 2 point change in COPM score will be compared between the two groups using Chi square or Fishers exact test.

Correctness of exercise performance is measured on an ordinal scale. This will analysed for between group differences using a Mann Whitney U test.

Statistical significant will be set as p<0.05. All statistical analyses will be performed using STATA version 14.1 (TestCorp, Texas).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/08/2016

Actual

8/08/2016

Date of last participant enrolment

Anticipated

2/03/2018

Actual

26/02/2018

Date of last data collection

Anticipated

11/05/2018

Actual

17/06/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6050 - Coolbinia

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Non-Government Centre Support, Department of Education, Government of Western Australia

Address [1]

NGCS Committee
School of Special Education Needs: Disability
Department of Education
PO Box 1190
Hillarys WA 6923

Country [1]

Australia

Primary sponsor type

Other

Name

Ability Centre

Address

PO Box 61
Mt Lawley WA 6069

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Curtin Universtiy

Address [1]

Kent Street
Bentley WA 6102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin Human Research Ethics Committee

Ethics committee address [1]

Curtin University
Kent Street
Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/05/2016

Approval date [1]

22/07/2016

Ethics approval number [1]

Summary

Brief summary

Children with cerebral palsy (CP) and other physical disabilities are often prescribed individualised home exercise programmes by their therapists. These exercises may target flexibility, strength, endurance, gross motor development, balance, and sports skills. Home exercise programmes are used to complement the face-to-face physiotherapy sessions and help children to complete the number of exercise sessions, per week, required to achieve their goals.

Physitrack 'Registered Trademark' is an online, app-based package for therapists to provide exercise programmes. It is designed to help people complete exercise programs with videos of exercises, audio and written instructions, a calendar, and capacity to communicate online with your therapist. We want to see if using Physitrack assists children with Cerebral Palsy to perform their exercises correctly, adhere to their exercise programme, and achieve their personal goals.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Rowan Johnson

Address

Ability WA
PO Box 61
Mount Lawley WA 6929

Country

Australia

Phone

+61 1300106016

Fax

[email protected]

Contact person for public queries

Name

Mr Rowan Johnson

Address

Ability WA
PO Box 61
Mount Lawley WA 6929

Country

Australia

Phone

+61 1300106016

Fax

[email protected]

Contact person for scientific queries

Name

Dr Noula Gibson

Address

Perth Children's Hospital
15 Hospital Avenue
Nedlands, Western Australia 6009

Country

Australia

Phone

+61411588917

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified quantitative data for all outcome measures for each participant

When will data be available (start and end dates)?

23/12/2020 - 23/12/2037

Available to whom?

IPD is available upon request from the lead researcher noting that requestors will need to sign a data access agreement.

Available for what types of analyses?

Meta-analysis

How or where can data be obtained?

Email the lead researcher: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15128	Study protocol	Johnson, R. W., Williams, S. A., Gucciardi, D. F., Bear, N., & Gibson, N. (2018). Evaluating the effectiveness of home exercise programmes using an online exercise prescription tool in children with cerebral palsy: protocol for a randomised controlled trial. BMJ open, 8(1), e018316.	https://bmjopen.bmj.com/content/8/1/e018316

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		December 22, 2020 Johnson, R. W., Williams, S. ... [More Details]	370695-(Uploaded-09-02-2022-17-16-40)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Evaluating the effectiveness of home exercise programmes using an online exercise prescription tool in children with cerebral palsy: Protocol for a randomised controlled trial.	2018	https://dx.doi.org/10.1136/bmjopen-2017-018316
Embase	Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial.	2020	https://dx.doi.org/10.1136/bmjopen-2020-040108

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

Trial Review

Documents added manually

Documents added automatically