ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000249651p

Ethics application status

Not yet submitted

Date submitted

6/02/2023

Date registered

8/03/2023

Date last updated

8/03/2023

Date data sharing statement initially provided

8/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Running training for children with symptomatic hypermobility - a feasibility study

Scientific title

The feasibility and effect of a running training program on goal attainment in children with hypermobility spectrum disorder

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hypermobility Spectrum Disorder

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Running Intervention protocol according to Consensus on Exercise Reporting Template (CERT guidelines)

Adapted from: Gibson N, Chappell A, Blackmore AM, Morris S, Williams G, Bear N, Allison G. The effect of a running intervention on running ability and participation in children with cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2018 Dec;40(25):3041-3049. doi: 10.1080/09638288.2017.1367426. Epub 2017 Aug 21. PMID: 28826274.

1. Exercise Equipment: Trampette, stairs, resistance bands, single step, cones, agility ladder, dumbbells, leg curl machine, leg press machine

2. Qualifications and training: Two or three senior physiotherapists (PTs) with experience in working with school-aged children with hypermobility spectrum disorder (HSD) will deliver the program. The lead physiotherapist has delivered this intervention for the past 8 years, undertook 15 hours training in rehabilitation of running for people with neurological conditions and undertook eight hours training in motivational interviewing which was delivered by a clinical psychologist.

3. Individual/group: Individualized programs will be established and progressed at individual rates. The individualized program will be delivered and performed in a group setting once per week and a home program provided to be performed three times per week.

4. Supervision: Participants will be supervised in a ratio of 1PT:3participants. The participants will be taught the exercises individually and once performing the exercise correctly, allowed to practice independently.

5. Adherence to exercise: Progress notes will be completed at the end of each session, including the level of difficulty of each exercise and number of repetitions, or time spent doing the exercise. Attendance will be recorded for each participant and reported as a number of sessions out of 10 possible sessions. Home program exercises will be prescribed weekly and home exercise diary sheets will be collected at the end of each week.

6. Motivation strategies: Participants will be encouraged with verbal feedback about their technique, both what was done well and what changes need to be made. Participants will be given a time or number of repetitions to aim for. Exercises will sometimes be incorporated into games. Participants will also be encouraged to “buddy up” with another group participant to encourage each other. Each participant will have a home program, with diary sheets issued and collected weekly to encourage adherence. Participants who do not attend a session without informing PTs of the reason will be called by one of the PTs the next day to encourage attendance. The PTs will use motivational interviewing techniques during the weekly one hour sessions to encourage participants to explore options for adhering to home prescribed exercises and for exploring and promoting physical activity in the community.

7a. Decision rule(s) for determining progression: Once the participant is consistently able to perform the exercise with good technique they will be progressed to the next level. Speed and quality of movement will be prioritized over load as the focus on ballistic movement is necessary for running.

7b. How program was progressed: The program incorporates a series of hierarchically challenging activities. [See Williams & Schache 2010 and Schache et al. 2014 for more detail on the activities].
Participants will be prescribed relevant activities to address the running gait impairments demonstrated for that individual. The individually tailored exercises will be derived by the therapist viewing slow motion observational sagittal and frontal video footage of the participant’s running gait and determining the abnormalities affecting the acquisition of typical running skill. The exercises/activities will target the three main muscle groups responsible for forward progression when walking and running, i.e. the ankle plantar flexors, hip flexors and hip extensors. Exercises will be progressed once good form/technique is demonstrated on the starting activity. The exercises may be performed on the trampette until the participant is able to perform the exercises overground. For simulation of leg turnover and appropriate foot contact alignment an activity termed the “claw” exercise will be utilized [See Williams & Schache 2010 and Schache et al., 2014 for more detail]. For participants whose motor control does not enable good technique, activities such as the “claw” will either be broken down into components, or facilitated with therapist handling until the participant is able to perform a cycle with good technique. This will be progressed by decreasing therapist facilitation and eventually adding resistance (for e.g., with resistance bands). Once the participant can run with good technique overground, slopes may be added, and the distance or speed increased depending on the individual goal. From slopes, participants progress to agility exercises. These began with simple cutting/side stepping exercises and progress in complexity. Once a reasonable level of agility is attained, sport specific skills relevant to the individual participant’s interest may be introduced.

8. Exercises: Please refer to Williams & Schache 2010 and Schache et al. 2014 for the types of exercises utilized to address different running impairments. Examples of exercises which may be used include: alternating feet on trampette, alternating feet with a knee lift on trampette, jumping, hopping, fast feet overground, fast feet with a knee lift, triple extension, skipping, running. Each session will utilise the following structure:
1 Warm-up: 5 min
2 Individualized exercises/activities: 45 min
3 Cool down: 5 min
4. Provision of home program: 5 min

9. Home program: All participants will receive a home program to be performed three times per week for approximately 15 minutes, which contains individually tailored exercises that have been learnt with the PTs and which they can perform independently with good technique.

10. Non-exercise components N/A

11. Type and number of adverse events: Adverse events will be recorded and followed up as per the protocol.

12. Setting: A community paediatric allied health clinic with outdoor grassed area and access to exercise equipment.

13. Exercise intervention: Participants are asked to attend one one-hour session per week with the home program performed another three times per week, for a total of 10 weeks.

14a. Generic/tailored: Each participant will receive an individually tailored program based on a core group of hierarchical exercises

14b. How the exercises are tailored: The exercises will be tailored for each participant according to the identified impairments impacting their running skill and by level of difficulty. The PTs will progress the exercises according to the participant’s response. Adjunct exercises will be added by the PTs if necessary, for example hip abductor strengthening exercises may be added if the participant cannot stabilize the pelvis while performing the exercises.

15. Decision rule for starting level: Participants will be started at the most challenging level they can perform with good technique.

16a. Adherence/fidelity: PTs will meet for 10 min following each session to discuss issues experienced by individuals in the group and find solutions.

Intervention code [1]

Rehabilitation

Comparator / control treatment

No control group
Single case study design
Participants will be randomized to start the intervention after four, five or six weeks of baseline measures, while undertaking their usual exercise schedule.
In this design, all participants will receive the same intervention.

Control group

Active

Outcomes

Primary outcome [1]

Completion of set goals assessed using Goal Attainment Scaling

Timepoint [1]

T0 (start of baseline phase)
T1 (end of baseline phase)
T2 (end of 10 weeks intervention)
T3 (end of withdrawal phase, 6 weeks post-intervention completion)

Secondary outcome [1]

Muscle Power Sprint Test

Timepoint [1]

3-weekly throughout the study for up to 6 weeks post-intervention completion

Secondary outcome [2]

Submaximal hopping on portable force plate to assess leg stiffness

Timepoint [2]

3-weekly throughout the study for up to 6 weeks post-intervention completion

Secondary outcome [3]

Adolescent Physical Activity Recall Questionnaire

Timepoint [3]

T0 (start of baseline phase)
T3 (end of withdrawal phase, 6 weeks post-intervention completion)

Secondary outcome [4]

KIDSCREEN-10 to assess health-related quality of life

Timepoint [4]

T0 (start of baseline phase)
T1 (end of baseline phase)
T2 (end of 10 weeks intervention)
T3 (end of withdrawal phase, 6 weeks post-intervention completion)
T4 (follow-up, 6 months post-intervention completion)

Secondary outcome [5]

Running gait analysis assessed by 2-dimensional video analysis of sprinting

Timepoint [5]

Secondary outcome [6]

Pain Visual Analogue Scale

Timepoint [6]

At start and finish of each intervention session

Secondary outcome [7]

Fatigue Visual Analogue Scale

Timepoint [7]

At start and finish of each intervention session

Secondary outcome [8]

Borg Rating of Perceived Exertion

Timepoint [8]

At start and finish of each intervention session

Secondary outcome [9]

Recruitment / Demand survey to assess feasibility

Timepoint [9]

Baseline

Secondary outcome [10]

Staff semi-structured interview to assess acceptability, implementation, practicality and integration, barriers and enablers to implementation of the intervention program.

Timepoint [10]

T2 (end of 10 weeks intervention)

Secondary outcome [11]

Semi-structured interviews with participants and carers will be assessed as a composite secondary outcome. The interviews will assess acceptability. The overarching question is “What could children with symptomatic hypermobility tell us about the value of participation in a targeted running intervention programme for their physical performance,
attendance, involvement and kinesiophobia?

Timepoint [11]

T0 (Baseline)
T2 (end of 10 weeks intervention)
T4 (follow-up, 3 months post-intervention completion)

Secondary outcome [12]

Attendance will be collected with study-specific attendance lists

Timepoint [12]

Weekly during the intervention phase

Secondary outcome [13]

Adherence to home exercise program will be assessed using a study-specific home exercise form.

Timepoint [13]

Weekly during the intervention phase

Secondary outcome [14]

Fidelity to the intervention protocol will be assessed using an audit of study-specific session notes.

Timepoint [14]

Weekly during the intervention phase

Secondary outcome [15]

Patient and carer satisfaction with the intervention as measured on a 10 point Likert scale with opportunity to comment

Timepoint [15]

T2 (end of 10 weeks intervention)

Secondary outcome [16]

Staff satisfaction with the intervention, as measured on a 10 point Likert scale with opportunity to comment

Timepoint [16]

T2 (end of 10 weeks intervention)

Secondary outcome [17]

Number and type of adverse events
Possible adverse events include falls, minor sprains and strains or asthma attack. Adverse events will be recorded on a study-specific form and the study protocol followed.

Timepoint [17]

Weekly during the intervention phase

Secondary outcome [18]

Evaluation of resources will be undertaken through staff semi-structured interviews.

Timepoint [18]

T2 (end of 10 weeks intervention)

Secondary outcome [19]

Accelerometry - wrist mounted Actigraph

Timepoint [19]

T0 (start of baseline phase)
T3 (end of withdrawal phase, 6 weeks post-intervention completion)

Secondary outcome [20]

Lower Extremity Grading System (LEGS) will be used to assess to assess lower extremity neuromuscular performance

Timepoint [20]

Secondary outcome [21]

Tampa Scale of Kinesiophobia

Timepoint [21]

Secondary outcome [22]

Cost of resources will be assessed using an audit of study specific financial information

Timepoint [22]

T2 (end of 10 weeks intervention)

Eligibility

Key inclusion criteria

Children 9 to 18 years old with hypermobile Ehlers-Danlos syndrome (hEDS) or hypermobility spectrum disorder (HSD), a Beighton Score of at least 6/9, a goal to improve their running, and able to attend one training session each week for 10 weeks.

Minimum age

9 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Children will be excluded if they are unable to undertake strenuous exercise for medical reasons, have cognitive or behavioural problems that hinder working in a group, have coexisting neurological or orthopaedic conditions or have had an injury in the past 6 months that impacts their ability to run.

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 assessing the outcomes

Intervention assignment

Other

Other design features

Experimental single case-study design
Participants will be randomised to begin the intervention after four, five or six weeks of baseline measures.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/06/2023

Actual

Date of last participant enrolment

Anticipated

1/10/2023

Actual

Date of last data collection

Anticipated

30/06/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Western Kids Health - Shenton Park

Recruitment postcode(s) [1]

6008 - Shenton Park

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Western Kids Health

Address [1]

Victoria House
4 Thorburn Way
Shenton Park WA 6008

Country [1]

Australia

Funding source category [2]

University

Name [2]

Curtin University

Address [2]

Kent St, Bentley WA 6102

Country [2]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Western Kids Health

Address

Victoria House
4 Thorburn Way
Shenton Park WA 6008

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Curtin University

Address [1]

Kent St, Bentley WA 6102

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Curtin University
Kent St, Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/02/2023

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Brief project background & objectives: Running is an important skill that enables children to participate in physical activity. Children with symptomatic joint hypermobility often have difficulty with running due to various factors including difficulty generating lower limb power, fear of movement (kinesiophobia), pain or fatigue. This impacts participation in physical activity and everyday life. A running intervention conducted by this research group has been demonstrated to assist children with cerebral palsy to achieve running goals.  

Objectives: This pilot study will investigate if a running intervention is a feasible intervention to improve running performance and reduce kinesiophobia for children with symptomatic joint hypermobility. 

Hypotheses:
1. Children with symptomatic joint hypermobility will achieve their running-related goals following a running intervention programme.
2. Children with symptomatic joint hypermobility will have reduced fear of movement following a running intervention programme.

Significance of the project: There is currently no evidence with regards running or running interventions for children with hypermobility. Running is important for children’s participation in physical and social activities. Children with hypermobility can find it difficult to participate in physical activity, yet physical activity is critical for the health of children.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Annie Chappell

Address

Western Kids Health
2/84 Matlock St.
Mt Hawthorn WA 6050

Country

Australia

Phone

+61 0412638093

Fax

[email protected]

Contact person for public queries

Name

Annie Chappell

Address

Western Kids Health
2/84 Matlock St.
Mt Hawthorn WA 6050

Country

Australia

Phone

+61 8 61122977

Fax

[email protected]

Contact person for scientific queries

Name

Annie Chappell

Address

Western Kids Health
Victoria House
4 Thorburn Way
Shenton Park WA 6008

Country

Australia

Phone

+61 8 61122977

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

After de-identification, objective data underlying published results will be available upon request.

When will data be available (start and end dates)?

Immediately following publication, for 5 years.

Available to whom?

Data will be available to researchers who provide a methodologically sound proposal.

Available for what types of analyses?

Data will be available to achieve the aims in any approved proposal.

How or where can data be obtained?

Data will be made upon request to the primary investigator:
[email protected]

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
17567	Study protocol		384892-(Uploaded-06-02-2023-13-32-57)-Study-related document.docx
17588	Statistical analysis plan	Statistical Analysis Plan: Quantitative data will... [More Details]
17589	Informed consent form		384892-(Uploaded-06-02-2023-13-13-35)-Study-related document.docx
17590	Ethical approval	Ethical approval is being sought from Curtin Unive... [More Details]

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.

Trial Review

Documents added manually

Documents added automatically