Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000506897
Ethics application status
Approved
Date submitted
4/03/2021
Date registered
30/04/2021
Date last updated
20/10/2022
Date data sharing statement initially provided
30/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
CPMovetime: elliptical training in school aged children with cerebral palsy.
Scientific title
CPMovetime: the effect of elliptical training sessions on sedentary behaviour, health and well-being in school aged children with cerebral palsy, classified within GMFCS levels IV and V.
Secondary ID [1] 303605 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 320975 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318782 318782 0 0
Physiotherapy
Neurological 318783 318783 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The efficacy of CP-Movetime will be evaluated using a single case experimental design (SCED) featuring concurrent, randomised, replication multiple-baseline design across participants with cerebral palsy, aged between 5 and 17 years with severe motor impairments (i.e. Gross Motor Function Classification System (GMFCS) levels IV and V). The phases will include A and B (where A is the baseline and B is the intervention). The study will be conducted and reported as outlined in the Single Case Reporting Guidelines in Behavioural Interventions (SCRIBE) 2016 statement.

According to the TIDieR:
Why (rationale, theory and goal of elements of the intervention): Non-ambulant children with cerebral palsy (CP) experience more sedentary behaviour, spending up to 96% of their waking day sitting. With no evidence-based interventions available, this can have a devastating impact on health and well-being. With the current recommendations for physical activity being 3 sessions a week for 8 consecutive weeks, CPMovetime aims to develop new interventions based on this dosage to provide opportunities for meaningful and safe physical activity and reduce sedentary behaviour for better health outcomes in children with cerebral palsy.
What (is needed for intervention delivery): An ellipitcal trainer, hoist - to enable partial body weight support over the trainer, heart rate monitor and engagement materials such as adapted visual materials and adapted video games.
What (procedures and activities used in the intervention): Each session will by 1 hour in duration and consist of 2, 10 minute sessions on an elliptical trainer. The child or participant will be supported with a harness to enable them to be safely upright with partial body weight support. The elliptical trainer will enable passive movements of the legs and will be powered through the arm holds by the therapist to ensure appropriate speed and direction. The aim is not to attain a specified speed, rather, given the varying effects of lower limb spasticity or dystonia, the aim will be to maintain consistent and slow movement whilst ensuring the participant is comfortable with no resisting of movement. Between the sets and after the 2nd set, participants will engage in a standing activity for 10 minutes. This may include engagement in an adapted video game (Nintendo Switch utilising the Horii Flex controller for switch adapted games - already commercially available) or gross motor activities such as kicking a ball or bowling.
Who will provide the expertise: Each session will involve a team of 3 therapists (combination of physiotherapist, occupational therapist and therapy assistant) which is required for the transfer.
How (modes of delivery): Individual sessions
Where (location): in a community-based therapy centre.
When and how much (dosage): Attend 3, 1 hour sessions a week over 8 weeks.
Tailoring (personalisation of intervention): All children will follow the protocol that was specifically designed for this study. However, there may be some adaptations to enable the child to complete the activity in the most efficient way. This includes taking into account preferences (for interactions, experiences and development of experiences of enjoyment and success) and positioning when upright for comfort.
How well (fidelity): A manual of intervention and onsite training with credentialing sign off by the Chief Investigator. This will ensure that the intervention is provided consistently.
Session adherence will be monitored by checklists which need to be completed throughout the session and recorded as a progress note.

Each participant will be randomly assigned to one of three conditions: 1) Phase A (baseline) for 2 weeks, Phase B (intervention for 8 weeks); 2) Phase A (baseline) for 4 weeks, Phase B (intervention) for 8 weeks; or 3) Phase A (baseline) for 6 weeks, Phase B (intervention) for 8 weeks.
Intervention code [1] 319891 0
Rehabilitation
Intervention code [2] 320166 0
Treatment: Other
Comparator / control treatment
Each individual will act as their own control i.e. the individual's performance in the baseline period will be compared to the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 326725 0
Goal Attainment Scale (GAS)
The Goal Attainment Scale (GAS) is used to enable individualised goal setting to enables goals other than just walking to be evaluated in a meaningful and relevant way. The GAS is a recommended assessment tool for paediatric rehabilitation research particularly as activity and participation outcome measures as it is sensitive to change
Timepoint [1] 326725 0
The GAS is a target behaviour that will be measured weekly through the A (baseline) and B (intervention) phase of the trial, with 8 weeks post intervention commencement (end of phase B) being the primary endpoint.
Primary outcome [2] 326726 0
Performance and satisfaction ratings on the Canadian Occupational Performance Measure (COPM)
The COPM is a widely used outcome measure for children with CP that identifies performance problems in a top down approach in both clinical practice and research. This measure is client/family centered and is therefore the most suitable measure for activity and participation in this population. The COPM is valid, reliable and responsive to changes following intervention from the patient/family’s perspective.
Timepoint [2] 326726 0
The COPM is a target behaviour that will be measured weekly through the A (baseline) and B (intervention) phase of the trial, with 8 weeks post intervention commencement (end of phase B) being the primary endpoint.
Secondary outcome [1] 392483 0
Body Composition (bone density, lean muscle and body fat percentage).

The Dual-energy X-ray Absorptiometry or DXA scanner will be used to determine bone and body composition. The DXA is suitable for use in this population because of the accuracy in determining body composition as well as regional body composition. Ionizing radition is very small (<10 microSieverts) for a whole body scan and this is equivalent to a normal background radiation received over a single day when at sea level. The scan will however, be conducted by a licensed technologist with established competency and reliability in performing the scans.

Each participant will be asked to lie on the table and to stay still for as long as possible. For children in this study, a two person transfer will be required (from wheelchair to bed). This will be done with a parent and a therapist on site for the DXA scan positioning. The use of foam blocks and straps will be used to position and support the participant on the table so that they are safe and secure given that this population will not have the postural control to attain and maintain a static position. The scan itself will take up to 5 minutes (dependent on how static the participant is able to remain). Outcomes of interest include bone density (produced by Z scores) as well as fat and lean mass percentages. This is a composite secondary outcome measure.
Timepoint [1] 392483 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [2] 392484 0
Rectus Femoris muscle morphology description: Muscle thickness

Real time Ultrasound
Ultrasonography is a reliable and clinically relevant method of determining and measuring muscle thickness in children with cerebral palsy. It is a safe and non-invasive technique with no exposure to ionising radiation. Real-time ultrasound is performed quickly and accurately within the clinic, so there is no need for anesthetics or hospital admissions.

Real time ultrasound imaging (B Mode Ultrasound) will be used to determine bilateral rectus femoris muscle thickness, muscle length and tendon length. A standardised position will be used with the Hip and knee at 90 degrees of flexion. This position will be supported by foam blocks and by a research assistant, using a goniometer and angle finder to maintain this position.

Gel will be applied to the skin with a generous quantity used to ensure no compression or distortion of the muscle which will affect the quality and reliability of the measure.

The distance between the anterior superior iliac spine and the superior border of the patella will be measured and marked with a pen on the skin (as a horizontal line).

The probe will be oriented to this line, running longitudinal to the plane. Images will be taken at this point until there are 5 successive decreases in measurements. This method will be optimised during the pilot testing.
Timepoint [2] 392484 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [3] 392485 0
Blood test evaluation: glucose

Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte-balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i-STAT cartridge and using the i-STAT Blood Gas Analyzer (i- STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).
Timepoint [3] 392485 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [4] 392486 0
CPCHILD
The CPCHILD a valid and reliable proxy measure specifically developed for non-ambulant children with CP to determine changes in functional health status, health related quality of life and caregiver burden. The measure contains 36 items and 7 domains which include (1) personal care/activities of daily living, (2) positioning, transfers and mobility, (3) comfort (includes pain and discomfort) and emotions, (4) communication and social interaction, (5) health, (6) overall quality of life.
Timepoint [4] 392486 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [5] 392491 0
Sleep Disturbance Scale
A screening questionnaire that has been used as a measure of children’s sleep (including domains of sleep onset, respiration, parasomnias such as restlessness and bruxism). It can be used to measure previous 4 weeks of children’s sleep, and has been used before and after sleep related interventions
Timepoint [5] 392491 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [6] 392492 0
Energy Expenditure (Metabolic Cart)
Expired gases will be measured throughout for the determination of Oxygen consumption (VO2), Carbon dioxide production (VCO2), Minute ventilation (VE), Respiratory Exchange Ratio (RER), tidal volume (Vt) and breathing frequency. Expired will be measured breath-by-breath by a TrueOne 2400 metabolic cart (ParvoMedics, Sandy, UT, USA) and averaged every 15 seconds. Expired gasses will be measured throughout the duration of the intervention but averaged over a 2 min period to ensure the participant has reached a physiological steady state. A physiological steady-state is required to ensure the validity of the calculation, where VO2 is truly representative of the energy expenditure. The physiological steady-state will be defined as the 2-min period between 4 and 10 min with an increase of less than 100 mL VO2, RER < 1.0 to assume a negligible anaerobic contribution to energy expenditure. Energy expenditure will be expressed in metabolic equivalents (MET) and kilojoules (kJ). Kilojoules will be calculated based on the KJ equivalent of the VO2 (kJ·L-1 O2, with a calorie-to-kilojoule conversion factor of 4184) determined by the RER using non-protein respiratory quotient. The gas analyser and ventilometer will be calibrated before each test using gases of known concentrations and a 3-l syringe (5530 series, Hans Rudolph, Inc., Shawnee, KS, USA). This method of measuring energy expenditure is considered the gold standard non-invasive method and has been the preferred method documented in the literature.
Timepoint [6] 392492 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [7] 392493 0
Sedentary behaviour
Participants will be asked to wear the watchlike device (Actigraph GTX3) over 7 days and nights. The raw data will then be convertedusing proprietory algorithms on the Actilife software to identify and quantify time spend in sedentary activities (i.e. lying down or sitting).
Timepoint [7] 392493 0
This is part of the generalisation probe measures which will occur 3 times: (1) in the 7 days leading into Pre baseline, (2)over 7 days Immediately pre-intervention which is also immediately post baseline and (3) for 7 days immediately post intervention.
Secondary outcome [8] 392494 0
Exit interview: feasibility of intervention
A semi-structured exit interview will occur after the "B" phase (intervention). This will enable the experience of the intervention and elements of feasibility to be described and explored from the perspective of children (if able to participate) and caregivers
Timepoint [8] 392494 0
Immediately post intervention after the "B" phase.
Secondary outcome [9] 393669 0
Rectus Femoris: Muscle length as measured by 2D muscle ultrasound as describe previously
Timepoint [9] 393669 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [10] 393670 0
Blood test evaluation: triglycerides

Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte-balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i-STAT cartridge and using the i-STAT Blood Gas Analyzer (i- STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).
Timepoint [10] 393670 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [11] 393671 0
Blood test evaluation: lipoproteins.
Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte-balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i-STAT cartridge and using the i-STAT Blood Gas Analyzer (i- STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).
Timepoint [11] 393671 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [12] 393672 0
Blood test evaluation: cholesterol.
Prior to and immediately following the intervention a blood sample will be collected at a pathology clinic by a trained phlebotomist. Each blood sample, a 125 ll electrolyte-balanced heparinized capillary tube (Clinitubes, Reflotron, Copenhagen, Denmark) will filled from a single fingerprick of the subject’s fingertip (Unistik_ 2 Extra; Owen Mumford Ltd, Oxford, UK). The filled capillary tube will be drawn into a GC4+ i-STAT cartridge and using the i-STAT Blood Gas Analyzer (i- STAT Corporation, East Windsor, NJ, USA), pH, PaCO2, PaO2, lactate, and calculated bicarbonate (HCO3 – ) will be measured. Blood sampling will occur through Pathwest (with written referral for measuring and testing glucose, triglycerides, low and high density lipoproteins and cholesterol).
Timepoint [12] 393672 0
This is part of the generalisation probe measures which will occur 3 times: (1) Pre baseline, (2) Immediately pre-intervention which is also immediately post baseline and (3) immediately post intervention.
Secondary outcome [13] 393677 0
Heart rate using a chest strap Polar Heart Rate monitor.

Heart rate will be recorded every 5 seconds throughout the intervention (S610, Polar, Finland).
Timepoint [13] 393677 0
Heart rate is a target behaviour during the elliptical training. This will be measured at each session during the intervention over the 8 weeks. The primary end point is the heart rate at post intervention (end of phase B).

Eligibility
Key inclusion criteria
Children with cerebral palsy, aged between 5 and 17 years classified within GMFCS levels IV and V.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable hip dislocations, orthopaedic surgery (lower limb) in the past 6 months, uncontrolled seizures.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
This is a single case experimental design featuring concurrent, randomised, replication multiple-baseline design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Means and standard deviations for interval data or medians and ranges for ordinal data will be calculated for each outcome measure for each participant. Comparisons between the A and B phases will be made. Individually using (a) visual analysis for changes in leve, (b) the 2 standard deviation band method (2SD) for interval data or percentage of nonoverlapping data method for ordinal data) to assess change in level and (c) the C-statistic to assess change in slope/trend. Statistical significance will be reached in the 2SD band method if 2 consecutive data points lay outside the 2 SD band in the B phase. In the percentage of nonoverlapping data method, a median line will be drawn from the baseline data, and the strength of change will depend upon the percentage of points in the B phase that lay above or below this line. The C-statistic will assess trend and the A phase, and if no significant trend is found, the C-statistic will be computed for the combined A and B phases. If this result is significant, a treatment effect will be found. Autocorrelation will be calculated for each outcome measure to ensure that serial dependency does not influence our interpretationof the visual anlaysis and the 2SD band method (as autocorrelation can decrease the variability in the data nad increase the likelihood of concluding incorrectly that a difference exists between the phases when using the visual analysis and 2SD band method. If autocorrelation is found, these methods will need to be applied with more caution.

Clinically meaningful change will be calculated for the Canadian Occupational Performance Measure where each individual participant will be assessed for meaningful change (score change of > 2). All data will be analysed using Stata 14.1 (StataCorp, College Station, TX). Qualitative data will be analysed using a method of trustworthiness

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
17/05/2021
Date of last participant enrolment
Anticipated
20/12/2021
Actual
11/10/2021
Date of last data collection
Anticipated
31/03/2022
Actual
20/12/2021
Sample size
Target
12
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308025 0
Charities/Societies/Foundations
Name [1] 308025 0
Telethon Trust
Country [1] 308025 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Healthy Strides Foundation
Address
23/954 Albany Highway East Victoria Park WA 6101
Country
Australia
Secondary sponsor category [1] 308752 0
University
Name [1] 308752 0
Curtin University
Address [1] 308752 0
Kent Street, Bentley WA 6102
Country [1] 308752 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308016 0
Curtin University
Ethics committee address [1] 308016 0
Ethics committee country [1] 308016 0
Australia
Date submitted for ethics approval [1] 308016 0
04/02/2021
Approval date [1] 308016 0
29/03/2021
Ethics approval number [1] 308016 0
HRE2021-0147

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109242 0
Dr Dayna Pool
Address 109242 0
The Healthy Strides Foundation, 23/954 Albany Highway East Victoria Park WA 6101
Country 109242 0
Australia
Phone 109242 0
+61 8 61092938
Fax 109242 0
Email 109242 0
daynapool@healthystridesfoundation.com
Contact person for public queries
Name 109243 0
Dayna Pool
Address 109243 0
The Healthy Strides Foundation, 23/954 Albany Highway East Victoria Park WA 6101
Country 109243 0
Australia
Phone 109243 0
+61 8 61092938
Fax 109243 0
Email 109243 0
daynapool@healthystridesfoundation.com
Contact person for scientific queries
Name 109244 0
Dayna Pool
Address 109244 0
The Healthy Strides Foundation, 23/954 Albany Highway East Victoria Park WA 6101
Country 109244 0
Australia
Phone 109244 0
+61 8 61092938
Fax 109244 0
Email 109244 0
daynapool@healthystridesfoundation.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified individual participant data will not be available.


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.