Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000705482
Ethics application status
Approved
Date submitted
17/05/2016
Date registered
27/05/2016
Date last updated
27/11/2019
Date data sharing statement initially provided
27/11/2019
Date results information initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of adaptive bungee trampolines in improving outcomes for children with physical disabilities
Scientific title
Efficacy of adaptive bungee trampolines in improving outcomes for children with physical disabilities
Secondary ID [1] 289242 0
None
Universal Trial Number (UTN)
U1111-1182-9688
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical disability 298814 0
Cerebral Palsy 298815 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298869 298869 0 0
Physiotherapy
Musculoskeletal 298880 298880 0 0
Other muscular and skeletal disorders
Neurological 298881 298881 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ‘adaptive bungee trampoline’ has been designed by engineers at Dreamfit to allow children with physical disabilities to be harnessed safely and utilise the trampoline. The harness is designed to provide comfort and stability around the trunk. The trampoline is accessible by hoist for children who are non-ambulatory or require the use of a walking aid.

Using a Single Subject Research Design, participants will be assessed once a week over a 5 week baseline period whereby they will continue with their 'normal care routine', they will be asked not to commence any new physical activities in this time.

The 12 week intervention period will consist of two 30-minute one-on-one sessions a week: one session run by a paediatric physiotherapist and the other session run by a physiotherapy student who has been trained by a physiotherapist (AG). The trampoline set up will be individualized for the child in regard to height and number of straps used to adjust the resistance to jumping. This will allow the physiotherapist to modify the ease with which the child can jump and change the muscle work of the child. This will be useful in adjusting the equipment to suit each child’s ambulatory status.
During the 30 minutes, the child will complete an individualised training program that has been developed by the physiotherapist. This will include a range of exercises that aim to keep the child as active as possible for the full half hour, while making sure it is safe and not too difficult for them. During this session, the child’s Heart Rate will be recorded every 5 minutes, as well as their Rating of Perceived Exertion. This will be recorded in the child’s training diary to gauge the exercise intensity throughout the session. In the child’s training diary, the trainer will also record the exercises the child successfully completed and will write any additional comments, for example, the amount of time the child spent during the session jumping.
Intervention code [1] 294781 0
Rehabilitation
Intervention code [2] 294789 0
Treatment: Other
Comparator / control treatment
No Control group- SSRD
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298339 0
Lower limb muscle strength will be assessed isometrically with a dynamometer, and functionally.

Dynamometer
Muscle strength will be measured with the Power Track II Commander (JTECH Medical, Salt Lake City, Utah) hand-held dynamometer (HHD). Three measurements on both sides will be taken and the median score will be reported. The use of a HHD can provide the limitation that the tester strength may affect the measurements obtained. For this reason the HHD will be stabilised with a belt. This appears to reduce the effects the tester may impose on the measurements. The use of belt-stabilisation overcomes the limitation that the tester may not be able to properly resist certain muscles, such as knee extensors, in individuals who are strong. Proper stabilisation of the HHD allows those who are inexperienced, or physically weak, to obtain more reliable results, The following muscles will be tested using the HHD following standardised protocols: gluteal muscle group, hamstrings, quadriceps and dorsiflexors..

Functional measure of strength
A more functional measure of muscle strength will be assessed by monitoring the ability of the patient to do calf raises, which are reported to test strength, endurance, function and performance of the triceps surae muscle group. Light palpation on the plantarflexor muscle group will be used to monitor muscle contraction. The maximum number of heels raises the child can perform on the weaker leg will be recorded, continuing measurements until the child: 1) asks to stop the test, 2) is unable to achieve raise onto metatarsal heads, 3) leans onto the wall with more than fingertip support after being given one verbal warning, 3) the non-weight bearing leg touches the floor for a second time after being given one verbal warning.
Timepoint [1] 298339 0
The weekly assessments throughout the 12 week intervention period will occur at the beginning of one of the training sessions (most likely the first of the two weekly sessions), and will take approximately 15 minutes.
Primary outcome [2] 298340 0
Function
(TUG, 2MWT)
For the Timed Up and Go (TUG), the participant will be required to stand up from a chair, walk at a comfortable safe, pace to the floor marker 3 metres away and then turn around and sit back down.

Weekly measurements of the 2MWT (as opposed to the 6MWT) will be performed to prevent fatigue and decrease the duration the weekly assessments take. The 2MWT can be modified from the 6-minute walk test (6MWT), this therefore means the child will be walking on a flat, hard surface to see how far they can walk in 2 minutes. The test will be performed in the child’s regular footwear and using their normal gait aids.
Timepoint [2] 298340 0
The weekly assessments throughout the 12 week intervention period will occur at the beginning of one of the training sessions (most likely the first of the two weekly sessions), and will take approximately 15 minutes.
Primary outcome [3] 298341 0
ROM
A goniometer will be used to measure passive range of movement (ROM) in lower limb joints (hip, knee, and ankle) following standardised protocols published by Norkin and White (2009).

Norkin CC, White DJ. Measurement of joint motion: a guide to goniometry. 4th ed. Philadelphia: Philadelphia : F.A. Davis; 2009.
Timepoint [3] 298341 0
The weekly assessments throughout the 12 week intervention period will occur at the beginning of one of the training sessions (most likely the first of the two weekly sessions), and will take approximately 15 minutes.
Secondary outcome [1] 323895 0
Participation (COPM)
The COPM was designed to allow participants to identify daily restrictions that impact on their performance in ADLs, and then prioritise these problems based on their importance to that patient. Responses from the interview can then be used to determine intervention goals depending on the difficulties reported in self-care, leisure activity or productivity. The use of COPM is believed to bring into practice a client-centred approach as goal setting is based upon valid measures of an individual’s self-perception of performance. The performance will be rated in regards to their self-selected goals on a numeric 1-10 scale: 1= not able to perform, or not satisfied with performance, at all; 10= able to perform extremely well, or are extremely satisfied with their performance.
Timepoint [1] 323895 0
'Probe'
Four 'probe' time-points assessment will be added to the weekly assessments. These will be timed at the beginning and end of the baseline phase, at the end of the intervention phase, and again at the follow up assessment (which will occur 4 weeks after the end of the program). These assessments will be completed separate to the training sessions (for the probe assessments coinciding with the intervention phase), and will take approximately 30 minutes.
Secondary outcome [2] 323896 0
Quality of Life
The CP-QOL will be completed by any participants in this study who have CP. The CP-QOL was designed to evaluate the effect interventions have on the child’s, adolescent’s, or carer’s perception of the child’s wellbeing and QoL. Questionnaires vary depending on the age of the child: 1) for primary carers of children between the ages of 4 and 12 years, 2) for adolescents between the ages of 13 and 18 years or their carers. The CP-QOL-Child mainly measures how the child feels about aspects of his/her daily life. The CP-QOL-Child measures seven domains including: social well-being and acceptance, functioning, participation and physical health, emotional well-being, access to services (parent-proxy), pain and feelings about disability and family health (parent-proxy).
Timepoint [2] 323896 0
'Probe'
Four 'probe' time-points assessment will be added to the weekly assessments. These will be timed at the beginning and end of the baseline phase, at the end of the intervention phase, and again at the follow up assessment (which will occur 4 weeks after the end of the program). These assessments will be completed separate to the training sessions (for the probe assessments coinciding with the intervention phase), and will take approximately 30 minutes.
Secondary outcome [3] 323907 0
Exercise Intensity
Exercise Intensity will be recorded by Heart rate (which the participants will wear for the duration of the session), and the 10 point Rating of Perceived Exertion scale.
Timepoint [3] 323907 0
Each training session, at 5 minute intervals.
Secondary outcome [4] 323908 0
Enjoyment
Participants will rate how much they enjoyed the session using a 5 point 'smiley face' likert scale.
Timepoint [4] 323908 0
Taken at the end of each training session.
Secondary outcome [5] 323909 0
Exit interview
After the training period is completed, participants and their parents will be asked to answer a series of questions about their opinion on the bungee trampoline equipment and program.
Timepoint [5] 323909 0
After the final trampoline session
Secondary outcome [6] 327487 0
The Gross Motor Function Measure-66 is a clinical tool designed to evaluate change in gross motor function in children with cerebral palsy over time or with intervention. The GMFM include an ordinal scoring, from 0 = does not initiate, to 3=completed, of dimensions of A: Lying and rolling, B: Sitting, C: Crawling and Kneeling, D: Standing, and E: Walking, Running and Jumping, whereby a total for each score can be calculated. Only the dimensions relevant for the participant will be observed in this study. The same physiotherapist, experienced in assessing the GMFM will take the assessments each week.
Timepoint [6] 327487 0
At each weekly assessment time point, and will take approximately 30 minutes to assess.

Eligibility
Key inclusion criteria
Participants aged between 5 and 18 years inclusive and having a physical disability involving their lower limbs will be included in this study. All participants will be screened by a physiotherapist prior to beginning the intervention to ensure that the intervention is suitable and safe for them. Participants will be included if they are classified as GMFCS I to IV.
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from this study if they have had any recent surgeries or illnesses that have resulted in prolonged changes in daily activity or bed rest, have atlanto-axial instability, haemophilia, any conditions causing a high risk of fractures (brittle bones, osteoporosis, and any other pathology fractures), uncontrolled seizures, or spinal fusions with internal fixations.

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
Single Subject Research Design, with a 5 week baseline period
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Line graphs will be generated for each child individually for each of the outcome measures. Means and standard deviations for interval data and medians and ranges for ordinal data will be calculated for each phase. Comparisons between baseline and intervention phases will be made using: (a) visual analysis (for changes in level), (b) the two standard deviation method (for interval data), or the percentage of non-overlapping data or PND method (for ordinal data) to assess change in level, and (c) the C statistic to assess changes in slope.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2016
Actual
18/08/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
24/06/2017
Date of last data collection
Anticipated
Actual
30/01/2018
Sample size
Target
4
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293618 0
University
Name [1] 293618 0
School of Physiotherapy and Exercise Science, Curtin University
Country [1] 293618 0
Australia
Primary sponsor type
Individual
Name
Sian Williams
Address
School of Physiotherapy and Exercise Science,
Curtin University
GPO Box U1974, Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 292449 0
University
Name [1] 292449 0
Curtin University
Address [1] 292449 0
School of Physiotherapy and Exercise Science,
Curtin University
GPO Box U1974, Perth, Western Australia 6845
Country [1] 292449 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295058 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 295058 0
Office of Research and Development
Curtin University
GPO Box U 1987
Perth, Western Australia 6845
Ethics committee country [1] 295058 0
Australia
Date submitted for ethics approval [1] 295058 0
19/05/2016
Approval date [1] 295058 0
13/07/2016
Ethics approval number [1] 295058 0
HRE2016-0126

Summary
Brief summary
This is a single-subject research design involving three participants. Recruitment will occur through Dreamfit and Ability Centre (which are affiliated) via dissemination of information to families. Screening of potential participants by a physiotherapist will occur to determine their suitability. Weekly assessment of outcome measures will occur during a 5-week baseline and 12-week intervention period, and at 4-week follow-up. These assessments will include lower limb range of movement (ROM), lower limb muscle strength, timed up and go assessment (TUG), heart rate during exercise, enjoyment (using a 5-point Smiley Scale) and a 2-minute walk test (2MWT). Probes (at the beginning and end of each phase) will include: the Canadian Occupational Performance Measure (COPM), and the Cerebral Palsy Quality of Life Questionnaire (CP-QOL). The trampoline intervention will involve twice weekly sessions at Dreamfit, where the bungee trampoline is located. The sessions will be run by the student (AG, one session a week) and a physiotherapist (one session a week), with an individualised programme suitable for each participants abilities and goals. At the conclusion of the program, an additional ‘exit’ interview will help to establish the usability of the adaptive bungee trampoline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65938 0
Dr Sian Williams
Address 65938 0
School of Physiotherapy and Exercise Science,
Curtin University
GPO Box U1987
Perth Western Australia
6845
Country 65938 0
Australia
Phone 65938 0
+61 8 9266 3645
Fax 65938 0
Email 65938 0
[email protected]
Contact person for public queries
Name 65939 0
Dr Sian Williams
Address 65939 0
Curtin University
GPO Box U1987
Perth Western Australia
6845
Country 65939 0
Australia
Phone 65939 0
+61 8 9266 3645
Fax 65939 0
Email 65939 0
[email protected]
Contact person for scientific queries
Name 65940 0
Dr Sian Williams
Address 65940 0
Curtin University
GPO Box U1987
Perth Western Australia
6845
Country 65940 0
Australia
Phone 65940 0
+61 8 9266 3645
Fax 65940 0
Email 65940 0
[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
Much of the individualized data are already reported via the reasearch pubication
Germain A, Blackmore AM, Gibson N, Newel B, Williams S. Effects of Adaptive Bungee Trampolining for Children With Cerebral Palsy. A Single-Subject Study: Pediatric Physical Therapy: April 2019 - Volume 31 - Issue 2 - p 165–174 doi: 10.1097/PEP.0000000000000584


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Germain A, Blackmore MA, Gibson N, Newel B, Willia... [More Details]

Documents added automatically
No additional documents have been identified.