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Trial registered on ANZCTR


Registration number
ACTRN12619001525178
Ethics application status
Approved
Date submitted
15/10/2019
Date registered
5/11/2019
Date last updated
5/11/2019
Date data sharing statement initially provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A sit-to-stand exercise program for children with cerebral palsy: a pilot randomized controlled trial.
Scientific title
A sit-to-stand exercise program for mobility and self-care function in children with cerebral palsy: a pilot randomized controlled trial.
Secondary ID [1] 299513 0
None
Universal Trial Number (UTN)
U1111-1241-7721
Trial acronym
None
Linked study record
Not linked

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 314762 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313092 313092 0 0
Physiotherapy
Neurological 313211 313211 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Brief name of intervention: A sit-to-stand exercise program
- Procedures: Children will receive 1 hour of physical therapy which consists of 30 minutes of sit-to-stand training and 30 minutes of regular physiotherapy. Sit-to-stand training has three phases: 1) repetition of part of the sit-to-stand task, 2) repetition of all the sit-to-stand movement, and 3) repetition of all the sit-to-stand movement applied within the context of self-care tasks. The regular physiotherapy program consists of 15 minutes of balance training in sitting and standing and 15 minutes of walking training with assistive devices that the individual child usually uses.
(The details of balance training and walking training will be individualised depending on the child’s ability.)
- Who provided: Two registered physiotherapists experienced in working with children with cerebral palsy. Child’s caregiver for the home program.
- Mode of delivery: Individually face-to-face 1 physiotherapist per 1 child and individually face-to-face 1 caregiver per 1 child.
- When and how much: Training duration is 6 weeks, the frequency of the training is 5/week, and session length 60 minutes; 30 minutes in a sit-to-stand training program and 30 minutes in regular physiotherapy.
- Intensity and volume: 3 sets of 25 repetitions of sit-to-stand and rest between each set 2-3 minutes for the second phase of the sit-to-stand training program. Thus, repetitions in this phase will be 75 repetitions/day.
- Where: 2 days a week in the private training room, located in the Physical Therapy Unit of Songklanagarind hospital, Thailand. And 3 days a week at child’s home as the home program which is the same exercise, time, frequency and duration as in the Physical Therapy Unit of Songklanagarind hospital.
- How well: Physiotherapists and parents will complete an exercise diary recording the number of repetitions of sit-to-stand in each session.




Intervention code [1] 315769 0
Rehabilitation
Comparator / control treatment
A routine physiotherapy program.
- Procedures: Children will receive 1 hour of a usual-care physiotherapy program. The routine physiotherapy program will consist of:
1. 15 minutes of the hot pack at both lower extremities.
2. 15 minutes of stretching of both lower extremities.
3. 15 minutes of balance training in sitting and standing.
4. 15 minutes of walking training with assistive devices that the individual child usually uses.
(The details of balance training and walking training will be individualised depending on the child’s ability.)
- Who provided: Two registered physiotherapists experienced in working with children with cerebral palsy and child’s caregiver for a home program.
- Mode of delivery: Individually face-to-face 1 physiotherapist per 1 child. And individually face-to-face 1 caregiver per 1 child.
- When and how much: Training duration is 6 weeks, the frequency of the training is 5/ week: 1 hour per day, 2 days a week for hospital session and 1 hour per day, 3 days a week for home program. Session length is 60 minutes (15 minutes of each task, 4 tasks).
- Where: 2 days a week in the private training room located in the Physical Therapy Unit of Songklanagarind hospital, Thailand. And 3 days a week at child’s home.






Control group
Active

Outcomes
Primary outcome [1] 321652 0
Mobility as assessed using Functional Independence Measure for Children (WeeFIM) in the mobility domain.
Timepoint [1] 321652 0
Baseline and 7th week after randomisation.
Primary outcome [2] 321816 0
Self-care function as assessed using Functional Independence Measure for Children (WeeFIM) in the self-care domain.
Timepoint [2] 321816 0
Baseline and 7th week after randomisation.
Secondary outcome [1] 375761 0
Sit-to-stand performance as assessed using Five time sit-to-stand test (FTTST).
Timepoint [1] 375761 0
Baseline and 7th week after randomisation.
Secondary outcome [2] 375762 0
Impact of the difficulty of caring for a child who has difficulty performing sit-to-stand on the caregiver as assessed using The Modified Caregiver Strain Index questionnaires (MCSI).
Timepoint [2] 375762 0
Baseline and 7th week after randomisation.
Secondary outcome [3] 375763 0
Caregiver perception (the experiences and perceived positive and negative effects of sit-to-stand training on the child’s primary caregiver of the experimental group) will be explored through semi-structured in-depth interviews.
Timepoint [3] 375763 0
7th week after randomisation.
Secondary outcome [4] 375764 0
Attendance will be assessed by a percentage of sessions attended (ratio of the number of training sessions attend to the total number of sessions prescribed, multiplied by 100),
Timepoint [4] 375764 0
7th week after randomisation.
Secondary outcome [5] 375765 0
Training adherence as assessed by the number repetitions of sit-to-stand completed in each session and recorded in the exercise diary as a proportion of the number prescribed by the physiotherapist.
Timepoint [5] 375765 0
7th week after randomisation.
Secondary outcome [6] 375766 0
Adverse events such as falling while performing sit-to-stand training will be recorded using the exercise diary.
Timepoint [6] 375766 0
While performing sit-to-stand training from baseline to 6 weeks.

Eligibility
Key inclusion criteria
Participants will be children with cerebral palsy aged 4 to12 years. The inclusion criteria of this study are as follows: (1) any type of cerebral palsy (e.g. spastic, athetoid, ataxic); (2) classified as level III to IV on the Gross Motor Function Classification system (GMFCS); (3) able to sit-to-stand with or without assistance of caregiver or furniture without falling; (4) able to follow simple verbal instruction such as, ‘stand up, please’.
Caregivers of these children will be included if they are the primary carer for the child, and they speak Thai fluently.
Minimum age
4 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded if they meet any of the following criteria: (1) had an orthopedic intervention, selective dorsal rhizotomy, or botulinum toxin injection to the lower extremities within the previous 6 months; (2) orthopedic problems or medical conditions such as Osteogenesis Imperfecta, Arthrogryposis Multiplex Congenita, or Spinal Muscular Atrophy, that prevent children from participating in the exercise training.
Caregivers of these children will be excluded if they cannot understand and speak Thai fluently.

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 independent researcher who prepares the allocation sequence will prepare sealed opaque sequentially numbered envelopes. Only after written informed consent has been obtained and baseline testing has been completed will the next sealed envelope be opened and group allocated by an independent physiotherapist at the study site.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children with cerebral palsy will be stratified by their level of functional ability as classified by the Gross Motor Function Classification System (GMFCS), permuted blocks will be generated by an independent researcher not involved in recruitment, training or assessment, to randomly allocate participants to two groups (a usual care control group and a sit-to-stand experimental group).
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
Descriptive statistics will use to describe the demographic characteristic of participants. To evaluate the effect of sit-to-stand training on self-care and mobility task in children with cerebral palsy, ANCOVA will be used to compare the main outcomes of primary and secondary continuous outcomes between the control group and experimental group after 6 weeks using the baseline value as the covariate. Standardized mean differences will be calculated from change scores from week 0 to week 6, divided by the standard deviation of the difference scores. Standardized mean differences, also known as effect sizes, will be considered as small at 0.2, moderate at 0.5 and large at 0.8. Consistent with the principle of intention to treat, all available data will be analyzed according to group allocation, without consideration of the level of adherence. Between-group differences will be reported as mean differences with 95% confidence intervals. Statistical significance will be set at a=0.05.
For the qualitative data, thematic analysis will be used to identify key concepts from the qualitative data, which will be then clustered to create themes. Each interview will be audio-recorded and transcribed verbatim to Thai language first. To increase the trustworthiness, after the interview the researcher will provide participants with a copy of their transcript to check that it is an accurate representation of their thoughts and to see if they want to add any other comments. Then, the transcript will be translated into English (by an English expert from the International Affairs Office, Faculty of Medicine, Prince of Songkla University). The translated English transcripts will be checked to determine if they accurately represent the thoughts of the participants by the bilingual researcher. All interview transcripts in English will be coded line-by-line by two investigators independently. After the initial coding, the researchers will compare codes and discuss any differences until a consensus is reached. Thematic analysis will be used to identify key concepts and ideas, which will be clustered to create a thematic structure.
To assess attendance for the experimental group, exercise diary records of each child will be kept for each session, and the reason for non-attendance will be recorded. An overall attendance percentage (ratio of the number of training sessions attend to the total number of sessions prescribed, multiplied by 100) will be determined. Adherence will be described by the number of repetitions of sit-to-stand completed in each session as a proportion of the number prescribed by the physiotherapist. Adverse events will be categorized as serious or non-serious, expected or unexpected. Non-serious events do not need medical attention, and would not cause children to miss subsequent exercise session. Expected adverse events would be those events more likely to occur in the environment of exercise training such as falling. Adverse events unrelated to the study would be those events that are external to the exercise sessions, but stop a child from attending one or more sessions such as other an injury from other activities.
For the sample size estimation of this pilot study, to gain a preliminary estimate of the effects of sit-to-stand training on mobility and self-care function using the Functional Independence Measure for Children (WeeFIM), a sample size of n=42 (21 in each group) will be sufficient to detect a large, clinically worthwhile effect (0.8) in the mobility (4.3 units/35) and self-care (5.2 units/42) domains of WeeFIM(Oeffinger et al., 2008) at a level of 0.05 and power of 0.7. For an intervention of this type, it is not expected that such a large effect will be obtained; however, the sample will enable estimates of effect to be obtained for continuous primary and secondary outcomes that will inform future studies, and provide a sufficient sample that will likely achieve saturation for the qualitative analysis.


Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 21917 0
Thailand
State/province [1] 21917 0
Songkla

Funding & Sponsors
Funding source category [1] 304007 0
University
Name [1] 304007 0
Faculty of Medicine, Prince of Songkla University
Address [1] 304007 0
Faculty of Medicine, Prince of Songkla University
Kho Hong, Hat Yai District, Songkhla 90110, Thailand
Country [1] 304007 0
Thailand
Primary sponsor type
University
Name
Faculty of Medicine, Prince of Songkla University
Address
Faculty of Medicine, Prince of Songkla University
Kho Hong, Hat Yai District, Songkhla 90110, Thailand
Country
Thailand
Secondary sponsor category [1] 304180 0
None
Name [1] 304180 0
Address [1] 304180 0
Country [1] 304180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304501 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 304501 0
Ethics, Integrity & Biosafety, Research Office
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Ethics committee country [1] 304501 0
Australia
Date submitted for ethics approval [1] 304501 0
20/08/2019
Approval date [1] 304501 0
30/09/2019
Ethics approval number [1] 304501 0
HEC19389

Summary
Brief summary
The abnormal movements and posture in children with cerebral palsy who have moderate to severe disability can lead to impaired sit-to-stand function which can in turn impact on children’s ability to independently perform mobility and self-care tasks. Therefore, the primary aim of this pilot trial is to investigate the effects of sit-to-stand task-specific training on mobility and self-care function in children with cerebral palsy with moderate to severe motor dysfunction. The secondary aims are: to evaluate the effects of sit-to-stand training on: sit-to-stand performance and caregiver burden; while exploring the experiences and perceived positive and negative effects of the training on primary caregivers; their adherence to the intervention; and identification of any adverse events associated with training. This study will be conducted in Thailand, with 42 children with cerebral palsy aged 4 to 12 years randomly allocated to routine physiotherapy or sit-to-stand exercise training in addition to routine physiotherapy. Outcomes will be measured at baseline and 7 weeks after randomisation. It is hypothesised that sit-to-stand task-specific training is a feasible and useful intervention for improving mobility and self-care functions in children with cerebral palsy who have moderate to severe disability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97166 0
Miss Sirawee Chaovalit
Address 97166 0
School of Allied Health, La Trobe University, Plenty Rd & Kingsbury Dr, Bundoora VIC 3086, Australia
Country 97166 0
Australia
Phone 97166 0
+61 404414244
Fax 97166 0
Email 97166 0
18740097@students.latrobe.edu.au
Contact person for public queries
Name 97167 0
Prof Nicholas Taylor
Address 97167 0
School of Allied Health, La Trobe University, Plenty Rd & Kingsbury Dr, Bundoora VIC 3086, Australia
Country 97167 0
Australia
Phone 97167 0
+61 3 90918874
Fax 97167 0
Email 97167 0
n.taylor@latrobe.edu.au
Contact person for scientific queries
Name 97168 0
Prof Nicholas Taylor
Address 97168 0
School of Allied Health, La Trobe University, Plenty Rd & Kingsbury Dr, Bundoora VIC 3086, Australia
Country 97168 0
Australia
Phone 97168 0
+61 3 90918874
Fax 97168 0
Email 97168 0
n.taylor@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data (IPD) underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Unrestricted access via the website of journal publication linking to supplementary file containing individual participant's data.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5280 0
Study protocol
Citation [1] 5280 0
Link [1] 5280 0
Email [1] 5280 0
Other [1] 5280 0
Study protocol including the statistical analysis plan and details of ethical approval will be available through the publication of protocol and/or deposit in an institutional repository at Laa Trobe University.
Attachment [1] 5280 0
Type [2] 5281 0
Ethical approval
Citation [2] 5281 0
Link [2] 5281 0
Email [2] 5281 0
Other [2] 5281 0
Study protocol including the statistical analysis plan and details of ethical approval will be available through the publication of protocol and/or deposit in an institutional repository at Laa Trobe University.
Attachment [2] 5281 0
Type [3] 5282 0
Statistical analysis plan
Citation [3] 5282 0
Link [3] 5282 0
Email [3] 5282 0
Other [3] 5282 0
Study protocol including the statistical analysis plan and details of ethical approval will be available through the publication of protocol and/or deposit in an institutional repository at Laa Trobe University.
Attachment [3] 5282 0
Summary results
No Results