Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000836235
Ethics application status
Approved
Date submitted
8/05/2018
Date registered
17/05/2018
Date last updated
17/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Pilates intervention for school aged children with Hypermobility Spectrum Disorder.
Scientific title
Efficacy of Pilates intervention for school aged children with Hypermobility Spectrum Disorder on physical function and quality of life.
Secondary ID [1] 294259 0
Nil known
Universal Trial Number (UTN)
U1111-1210-3964
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypermobility Spectrum Disorder 306939 0
Joint Instability 307809 0
Condition category
Condition code
Musculoskeletal 306039 306039 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 306857 306857 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Pilates program will be designed and delivered by the chief researcher who is (i) an experienced physiotherapist with over 30 years clinical experience in paediatric physiotherapy and (ii) an accredited Pilates instructor for the past 15 years. The program will be provided on an individualized basis and include a structured combination of Pilates exercises performed on mat or Pilates equipment that is provided at an appropriate level and age for each child. Exercises will focus on basic muscle activation and patterns of movement that are the essential basis of Pilates. As pain is decreased and children improve in strength, body awareness and confidence, they will be progressed to a more challenging level of difficulty.

The intervention will be provided for 45 minutes, 2 times per week for 8 weeks with a home program of 45 minutes to be performed on one additional day under parental supervision.
This will meet basic guidelines for physical activity and strength training.
Each session is divided into sections to focus on specific body areas.
Section 1: Warm up (5 minutes)
Prepares the body for work and is typically a selection of mat exercises that involve trunk movement. Some examples are 'the roll down' and 'pelvic curl'.
Section 2: Regional Muscle training (30 minutes)
Includes specific areas of the body to ensure a complete body program:
- Foot work -develops the strength of muscles surrounding the knee, ankle and feet eg
'calf raises' in standing or 'prances' on the reformer.
- Abdominal work -focuses on specifically developing the abdominal muscles even
though the abdominals are engaged throughout the session eg 'chest lift' on the mat or
'hundred prep' on the reformer.
- Hip work -works on control of the hip joint an control of the pelvic- lumbar region eg
'leg circle' on the mat and 'hip circle down' with legs in straps on the reformer.
- Spinal articulation -works on spinal mobility and developing control of the deeper trunk
muscles eg 'rolling like a ball' on the mat or 'bottom lift' on the reformer.
- Arm work -works various muscle groups in the arm and shoulder girdle eg 'front
support' on the mat or 'triceps' with arms in straps on the reformer.
- Leg work -focus on upper leg and hip strength eg 'side leg lift' on the mat or 'skating'
on the reformer.
- Lateral flexion and rotation -works on symmetry of the rotators and lateral flexors of the
trunk eg 'spine twist' on the mat or 'mermaid' on the reformer.
- Back extension -exercises of the back extensors eg 'back extension' on the mat or
'breaststroke prep' on the reformer.
Section 3: Full body integration -specifically works on full body motion, balance and co-
ordination eg 'single leg standing' on the mat or 'scooter' performed on the reformer .
Section 4: Stretching and cool down (5 minutes)
Specific stretches depending on the need of the individual eg 'hamstring stretch' on the
mat or slow full trunk movement in standing such as 'roll down' focusing on slow deep
breathing.

At each session the Pilates instructor will record which exercises were performed, the number of repetitions, the equipment and amount of resistance used (number and colour of springs used on the reformer denotes whether mild, medium or heavy resistance).

The parent will be invited to observe each session and a photograph of the child performing the exercises will be taken to personalize the home program along with a written sheet which will include particular focus exercises that need additional training.
The home program will be composed of a number of mat exercises that continue to strengthen many parts of the body. One combination would be 'roll down', 'pelvic curl', 'chest lift', 'leg circles', 'side leg lifts', 'back extension', 'thread a needle', 'front support','single leg standing' and 'cat stretch'. If the child had difficulty with co-ordinating transverse abdominus (deep abdominal muscle) with the pelvic stability then some focus exercises would be to practice isolating transverse abdominus, then progressing to pelvic tilt while maintaining a transverse abdominus contraction before progressing to holding the transverse abdominus contraction with a 'pelvic curl' exercise
With the home program the parent will mark down the number of each exercise performed, sign and return it at the next session so adherence to the program can be monitored.
Intervention code [1] 300654 0
Rehabilitation
Comparator / control treatment
The design of this study is a single case experimental design with a multiple baseline design where each participant will act as their own control. Children recruited for the study will start in the study concurrently and will undergo multiple assessments in each of the baseline, intervention and withdrawal phase. The participants will be randomized as to the number of weeks they will stay in the baseline period so participant 1 will stay for a duration of 5 weeks, participant 2 for 6 weeks and participant 3 to 7 weeks during which they will not receive any physiotherapy or Pilates.
The participants will be staggered into the Pilates intervention phase which will be provided for 45 minutes, 2 times per week for 8 weeks with a home program of 45 minutes to be performed on one additional day under parental supervision. All participants will receive the same dose of intervention so will continue to be staggered into the withdrawal phase with participant 1 at week 13, participant 2 at week 14 and participant 3 at week 15 for another 5 week of baseline measurements. There will be one final assessment at 3 months post the completion of the intervention which will be participant 1 at week 26, participant 2 at week 27 and participant 3 at week 28. Throughout the withdrawal phase the participants will not receive any physiotherapy or Pilates.
The assessments used will be:
i) Pain levels with the PedsQL- Paediatric Pain Questionnaire which will be assessed
weekly throughout the 5,6 or 7 weeks of the baseline control period. That will be day
1, 8, 15, 22, 29 for participant 1; day 1, 8, 15, 22, 29, 36 for participant 2 and day 1, 8, 15,
22, 29, 36, 43 for participant 3.
ii) Muscle strength with a Lafayette manual muscle tester which will be assessed
weekly throughout the 5,6 or 7 weeks of the baseline control period. That will be day
1, 8, 15, 22, 29 for participant 1; day 1, 8, 15, 22, 29, 36 for participant 2 and day 1, 8, 15,
22, 29, 36, 43 for participant 3.
iii) Postural stability –Stand on one leg, Functional Reach Forward Reach, Functional
Reach Lateral with the Kids-BESTest which will be assessed weekly throughout the
5,6 or 7 weeks of the baseline control period. That will be day 1, 8, 15, 22, 29 for
participant 1; day 1, 8, 15, 22, 29, 36 for participant 2 and day 1, 8, 15, 22, 29, 36, 43 for
participant 3.
iv) Activity Monitor with the Actigraph and diary which will be assessed once in the last
week of the baseline control period. That will be day 29 for participant 1; day 36 for
participant 2 and day 43 for participant 3.
v) Fatigue levels with PedsQL Multidimensional Fatigue Scale which will be assessed on
the first and the last week of the baseline control period. That will be day
1 and 29 for participant 1; day 1 and 36 for participant 2 and day 1 and 43 for
participant 3.
vi) Health Related Quality of Life (HRQOL) with the PedsQL Paediatric Quality of Life
Inventory which will be assessed which will be assessed on the first and the last week
of the baseline control period. That will be day 1 and 29 for participant 1; day 1 and 36
for participant 2 and day 1 and 43 for participant 3.

Control group
Active

Outcomes
Primary outcome [1] 305195 0
Primary outcome measure: Pain levels
Objective: Measure change in pain levels.
Instrument: Visual Analogue Scale of the Paeds QL
Paediatric Pain Questionaire
Adverse Events: Nil expected as questionaire
Timepoint [1] 305195 0
Once/week in the initial baseline phase (5-7 weeks)
Once/week in the intervention period (8 weeks)
Once/week in the post intervention phase for 5 weeks
Once at 3 months post intervention.
Primary timepoints for participant 1 - week 5, 9, 13, 18 and 26
(primary endpoint)
Primary timepoints for participant 2 - week 6, 10, 14, 19 and 27
(primary endpoint)
Primary timepoints for participant 3 - week 7, 11, 15, 20 and 28
(primary endpoint)
Secondary outcome [1] 344473 0
Outcome: Muscle strength
Objective: Measure change in muscle strength
Instrument : Lafayette Manual muscle tester
Adverse Events: Nil expected as painfree
Timepoint [1] 344473 0
Once/ week in the initial baseline phase (5-7 weeks)
Once/ week in the intervention period (8 weeks)
Once/ week during the post intervention phase for 5 weeks
Once at 3 months post intervention.
Secondary outcome [2] 344474 0
Outcome: Activity monitor
Objective: Measure change in activity levels
Instrument: Actigraph and activity diary (composite secondary
outcome)
Adverse events: Nil expected as painfree
Timepoint [2] 344474 0
Once at the end of the initial baseline phase (5-7 weeks),
Once at the end of the intervention period (8 weeks)
Once at the end of the withdrawal phase (5 weeks)
Once at 3 months post intervention.
Timepoints for participant 1 will be week 5, 13, 18, 26
Timepoints for participant 2 will be week 6, 14, 19, 27
Timepoints for participant 3 will be week 7, 15, 20, 28
Secondary outcome [3] 344475 0
Outcome : Postural stability
Objective: Measure changes in postural stability
Instrument: Forward reach test - Kids-BESTest
Adverse events: Nil expected -will be closely supervised to prevent falls
Timepoint [3] 344475 0
Once/week in the initial baseline phase (5-7 weeks)
Once/ week in the intervention period (8 weeks)
Once/ week during the post intervention phase (5 weeks)
Once at 3 months post intervention.
Secondary outcome [4] 344476 0
Outcome: Health Related Quality of Life (HRQOL)
Objective: Measure changes in HRQOL
Instrument: Peds QL 4.0 Generic Scale
Adverse Events: Nil expected as questionaire
Timepoint [4] 344476 0
Once / 3-5 weeks in the initial baseline phase (5-7 weeks)
Once / 3-4 weeks in the intervention period (8 weeks)
Once / 3-4 in the post intervention phase (5 weeks).
Once at 3 months post intervention.
Timepoints for participant 1 will be week 1, 4 ,8, 12, 15, 18, 26
Timepoints for participant 2 will be week 1, 5, 9, 13, 16, 19, 27
Timepoints for participant 3 will be week 1, 6, 10, 14, 17, 20, 28
Secondary outcome [5] 344477 0
Outcome: Fatigue levels
Objective: Measure changes in fatigue levels
Instrument: Peds QL Multidimensional Fatigue Scale
Adverse Events: Nil expected as questionaire
Timepoint [5] 344477 0
Once every 3-5 weeks in the initial baseline phase (5-7 weeks)
Once every 3-4 weeks in the intervention period (8 weeks)
Once every 3-4 in the post intervention phase (5 weeks).
Once at 3 months post intervention.
Timepoints for participant 1 will be week 1, 4 ,8, 12, 15, 18, 26
Timepoints for participant 2 will be week 1, 5, 9, 13, 16, 19, 27
Timepoints for participant 3 will be week 1, 6, 10, 14, 17, 20, 28
Secondary outcome [6] 346813 0
Outcome : Postural stability
Objective: Measure changes in postural stability
Instrument: Lateral reach test -Kids-BESTest
Adverse events: Nil expected -will be closely supervised to prevent falls
Timepoint [6] 346813 0
Once/ week in the initial baseline phase (5-7 weeks)
Once/ week in the intervention period (8 weeks)
Once/ week during the post intervention phase for 5 weeks
Once at 3 months post intervention.
Secondary outcome [7] 346814 0
Outcome : Postural stability
Objective: Measure changes in postural stability
Instrument: Single leg standing test -Kids-BESTest
Adverse events: Nil expected -will be closely supervised to prevent falls
Timepoint [7] 346814 0
Once/ week in the initial baseline phase (5-7 weeks)
Once/ week in the intervention period (8 weeks)
Once/ week during the post intervention phase for 5 weeks
Once at 3 months post intervention.

Eligibility
Key inclusion criteria
1. Score of > than or equal to 6 on the Beighton Scale for hypermobility.
2. Score of > or equal to 1 painful joint felt at least 3 x/week for a 3 month period in the last 6 months.
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other heritable disorders of connective tissue
2. Other syndromes or significant complex medical or neurological
conditions (that may confound the outcomes)
3. Other intellectual impairment or behavioural disorders (that
impact on their ability to follow instructions)

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
The design of this trial will be a single case experimental design (SCED) with a multiple baseline design (MBD) where all participants will start in the study concurrently. Concealed random allocation will be used where a random series of numbers will be generated to correspond with the baseline duration (5 weeks, 6 weeks or 7 weeks). Then these will be randomly allocated to the participant number (e.g. P1, P2, P3).
Random order of the participants will be generated by a person who is neither the physiotherapist assessing the outcome measures or the physiotherapist providing the Pilates intervention.

The participants will have multiple outcome measures by a blinded assessor who is an experienced physiotherapist with children, who will not have knowledge of whether the child is participating in the baseline or intervention phase. To comply with the MBD, the initial baseline period of measures will be performed weekly and will randomised to staying in this period for between 5 to 7 weeks and so they will start the intervention at staggered times. The physiotherapy-led Pilates intervention will then be provided for 8 weeks with weekly outcome measures. Following intervention, children will participate in a withdrawal phase involving repeated measures weekly for 5 weeks post intervention and a final follow up assessment will take place approximately 3 months after the conclusion of intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The interpretation of data in this single case experimental design (SCED) will be based on graphic presentation and visual analysis. Also statistical methods will be employed to quantitatively supplement and analyse the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/05/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
14/12/2018
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10681 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 22401 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 298897 0
University
Name [1] 298897 0
The University of Queensland
Country [1] 298897 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Health and Rehabilitation Sciences
Therapies Building (84)
The University of Queensland
St Lucia
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 298482 0
None
Name [1] 298482 0
Address [1] 298482 0
Country [1] 298482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299840 0
Childrens Health Queensland HHS Research Ethics Committee
Ethics committee address [1] 299840 0
Ethics committee country [1] 299840 0
Australia
Date submitted for ethics approval [1] 299840 0
01/06/2017
Approval date [1] 299840 0
08/08/2017
Ethics approval number [1] 299840 0
HREC/17/QRCH/126
Ethics committee name [2] 300140 0
The University of Queensland Human Ethics Research Office
Ethics committee address [2] 300140 0
Ethics committee country [2] 300140 0
Australia
Date submitted for ethics approval [2] 300140 0
30/11/2017
Approval date [2] 300140 0
06/12/2017
Ethics approval number [2] 300140 0
20017002017/HREC/17/QRCH/126

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

Contacts
Principal investigator
Name 81730 0
Mrs Elizabeth Hornsby
Address 81730 0
C/- Dr Leanne Johnston
School of Health and Rehabilitation Sciences
Therapies Building (84)
The University of Queensland
St Lucia QLD 4072
Country 81730 0
Australia
Phone 81730 0
+61438336671
Fax 81730 0
Email 81730 0
[email protected]
Contact person for public queries
Name 81731 0
Elizabeth Hornsby
Address 81731 0
C/- Dr Leanne Johnston
School of Health and Rehabilitation Sciences
Therapies Building (84)
The University of Queensland
St Lucia QLD 4072
Country 81731 0
Australia
Phone 81731 0
+61438336671
Fax 81731 0
Email 81731 0
[email protected]
Contact person for scientific queries
Name 81732 0
Elizabeth Hornsby
Address 81732 0
C/- Dr Leanne Johnston
School of Health and Rehabilitation Sciences
Therapies Building (84)
The University of Queensland
St Lucia QLD 4072
Country 81732 0
Australia
Phone 81732 0
+61438336671
Fax 81732 0
Email 81732 0
[email protected]

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No Supporting Document Provided



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