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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
19/07/2018
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] 289209 0
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 298765 0
Physical Disablity 298766 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298815 298815 0 0
Physiotherapy
Neurological 298865 298865 0 0
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] 294743 0
Rehabilitation
Intervention code [2] 294744 0
Lifestyle
Intervention code [3] 294768 0
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] 298325 0
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] 298325 0
A) Completed weekly over 8 week intervention period
B) Completed at the end of 8 week intervention period
Primary outcome [2] 298326 0
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] 298326 0
Before and after the 8-week intervention period
Primary outcome [3] 298327 0
Proportion exercises completed correctly for each participant using the of Correctness of Exercise Performance (COEP) (Friedrich, Cermak & Maderbacher, 1996)
Timepoint [3] 298327 0
Measured at the beginning, the half-way point, and at the end of the 8 week intervention period.
Secondary outcome [1] 323850 0
Enjoyment of exercise from the children will be assessed using Physical Activity and Enjoyment Scale (PACES) questionnaire (Moore et al., 2009).
Timepoint [1] 323850 0
Before and after the 8-week intervention period
Secondary outcome [2] 323851 0
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] 323851 0
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] 323852 0
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] 323852 0
At the end of the study.
Secondary outcome [4] 323881 0
Confidence to exercise from parents and children will be assessed using an 11-point Numeric Rating Scale (NRS)
Timepoint [4] 323881 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 13245 0
6050 - Coolbinia

Funding & Sponsors
Funding source category [1] 293602 0
Government body
Name [1] 293602 0
Non-Government Centre Support, Department of Education, Government of Western Australia
Address [1] 293602 0
NGCS Committee
School of Special Education Needs: Disability
Department of Education
PO Box 1190
Hillarys WA 6923
Country [1] 293602 0
Australia
Primary sponsor type
Other
Name
Ability Centre
Address
PO Box 61
Mt Lawley WA 6069
Country
Australia
Secondary sponsor category [1] 292423 0
University
Name [1] 292423 0
Curtin Universtiy
Address [1] 292423 0
Kent Street
Bentley WA 6102
Country [1] 292423 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295045 0
Curtin Human Research Ethics Committee
Ethics committee address [1] 295045 0
Curtin University
Kent Street
Bentley WA 6102
Ethics committee country [1] 295045 0
Australia
Date submitted for ethics approval [1] 295045 0
19/05/2016
Approval date [1] 295045 0
22/07/2016
Ethics approval number [1] 295045 0

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 65838 0
Mr Rowan Johnson
Address 65838 0
Ability Centre
PO Box 61
Mount Lawley WA 6929
Country 65838 0
Australia
Phone 65838 0
+61894073612
Fax 65838 0
Email 65838 0
rowan.johnson@abilitycentre.com.au
Contact person for public queries
Name 65839 0
Mr Rowan Johnson
Address 65839 0
Ability Centre
PO Box 61
Mount Lawley WA 6929
Country 65839 0
Australia
Phone 65839 0
+61894073612
Fax 65839 0
Email 65839 0
rowan.johnson@abilitycentre.com.au
Contact person for scientific queries
Name 65840 0
Dr Noula Gibson
Address 65840 0
Ability Centre
PO Box 61
Mount Lawley WA 6929
Country 65840 0
Australia
Phone 65840 0
+61411588917
Fax 65840 0
Email 65840 0
noula.gibson@abilitycentre.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary