ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000688684

Ethics application status

Approved

Date submitted

12/06/2023

Date registered

26/06/2023

Date last updated

26/06/2023

Date data sharing statement initially provided

26/06/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

The impact of podiatric intervention on the quality of life and pain in children and adolescents with hypermobility.

Scientific title

The impact of custom-made orthotics on the quality of life and pain in children and adolescents with hypermobility

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

N.A.

Health condition

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

Generalised joint hypermobility

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Name: Custom made foot orthotic

The intervention is personalised

An off-weight bearing scanning CAD/CAM technology with high-resolution laser capability of 200dpi (dots per inch) was used (Konica Minolta Vivid 9i non-contact 3D). This device scans both feet in a supine position in approximately two minutes, enabling the clinician to maintain the child's subtalar joint (STJ) in a neutral position during the scanning process. The 3D foot scanned images enabled the clinician to then capture a detailed negative 3D mould of the foot. The de-identified foot scanned data was then shared electronically with an external independent manufacturing laboratory (Virtual orthotics, NSW, Australia).
The custom-made orthotics consisted of a prescription polypropylene shell which was individualised for each patient by an experienced podiatrist after completing a thorough biomechanical assessment which included foot posture index (FPI), bilateral ankle range of motion, knee position and tibial angles, and a subjective history to exclude other foot or ankle pathologies. Common prescription features included 10% arch fill, deep heel cup, extrinsic and intrinsic rear foot correction.

The patient continues to wear the orthotic every time they wear their shoes for example for school or when going for a walk. The clinician then reviews the orthotic and the patient at the 1 month and 3 month stage by re-performing the outcome measures to examine the effect. This is all done face to face. Patients mark down how often they are wearing the custom made orthotics. The total duration of the intervention is 3 months.

Location: Sydney Academy of Sport (Sports Medicine Centre)

Intervention code [1]

Treatment: Devices

Intervention code [2]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Pain (Visual Analogue Scale)
Performed on a piece of paper
The primary outcome of pain was measured using the VAS in which self-reported pain was indicated on a 100 mm line ranging from 0= “no pain” to 10= “worst possible pain”.

Timepoint [1]

Outcome measurements without intervention were measured at baseline

Then at 1 month post-commencement of intervention and at the 3-month post-commencement of intervention the outcome measurements were measured.

Primary outcome [2]

health-related quality of life (HRQoL)
was assessed with the validated instrument Pediatric Quality of life Inventory (PedsQL) Generic Core Scale which has previously been used for HRQoL assessment in both healthy paediatric populations as well as children with specific conditions. The scale is composed of 23-items and measures four functioning domains: physical, emotional, social and school functioning. A clinically important difference is considered to be a 5-point difference between time intervals. The PedsQL is available for children to self-report in different age ranges (5-7; 8-12; and 13-18) and scored out of a possible 100 points with a higher score indicative of better HRQoL

Timepoint [2]

Secondary outcome [1]

six-minute walk test (6MWT)
To measure functional endurance capacity based on guidelines from the American Thoracic Society the 6MWT, which is validated and self-paced over 6-minutes, was performed by each participant

Timepoint [1]

Secondary outcome [2]

PedsQL Multidimensional Fatigue Scale (MFS)
The PedsQL MFS is an 18-item validated measure of fatigue in child self-reported and parent proxy-report versions consisting of sleep, cognitive function and general fatigue domains. The scale instructions and scoring method /100 is the same as PedsQL generic core scale with higher scores indicating fewer difficulties.

Timepoint [2]

Secondary outcome [3]

Patient Global Impression of Change (PGIC)
To measure perception of the participants of the custom orthotic intervention impact since the last visit, the 7-point PGIC scale was used

Timepoint [3]

This outcome was only measured at 1 month post-commencement of intervention and at the 3-month post-commencement of intervention the outcome measurements were measured.
This was not used at baseline because it can only be measured after intervention

Eligibility

Key inclusion criteria

Children diagnosed with Generalised Joint hypermobility (GJH) were included if they were aged between 5 and 18 years with a Beighton Score of 5/9 or more (post-pubertal adolescents) and 6/9 or more (children and pre-pubertal adolescents), they experienced lower limb pain for at least one month in one or more joints and reported at least 2/10 pain level on the Visual Analogue Scale (VAS) during the week prior to the recruitment.

Minimum age

5 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Children with other chronic musculoskeletal, neurological, developmental, behavioural or syndromic conditions unrelated to their GJH were excluded. Also, children with recent physical trauma not related to symptomatic hypermobility, and children unable to walk or follow instructions, as well as those with contraindications to wearing orthotics (e.g. previous triple arthrodesis surgery), were deemed ineligible for this study.

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

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size calculations used pain as the primary outcome measure with a minimum clinically important difference of 8% in the paediatric population. Therefore, a successful outcome for a participant is defined as a decrease in pain of at least 8mm from baseline over one month period. A study of 50 or more patients has at least 80% power at 5% one-sided alpha to detect an increase above this rate.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

22/01/2020

Date of last participant enrolment

Anticipated

Actual

17/01/2023

Date of last data collection

Anticipated

Actual

10/04/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

The Children's Hospital at Westmead - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

ConnecTeD Foundation

Address [1]

G815, 75 Talavera Rd
Macquarie University, NSW 2109, Australia

Country [1]

Australia

Primary sponsor type

University

Name

Newcastle University

Address

University Dr, Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Executive Committee of the Sydney Children's Hospitals Network Human Research Ethics Committee

Ethics committee address [1]

 Corner Hawkesbury Road and Hainsworth Street, Westmead 2145 NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2018

Approval date [1]

14/03/2019

Ethics approval number [1]

LNR/18/SCHN/480

Ethics committee name [2]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/07/2019

Approval date [2]

04/07/2019

Ethics approval number [2]

Reference number H-2019-0221

Summary

Brief summary

Generalised joint hypermobility (GJH), defined as Beighton 6/9 or more, is prevalent in approximately 34 % of children and adolescents globally and associated with symptoms in about one in five of these children. Generalised Hypermobility Spectrum Disorder is the combination of Beighton 5/9 or greater for post-pubertal and 6/9 or greater for pre-pubertal children and adolescents together with musculoskeletal manifestations including joint pain, pes planus, hindfoot valgus, poor proprioception, joint laxity and instability.
 
Children with symptomatic GJH can experience joint laxity or joint instability and reduced strength and endurance during walking and other physical activities. Children also frequently report soft tissue injuries and pain following exercise, particularly in the lower limbs. Longitudinal studies have shown that children with GJH are more likely than their non-hypermobile peers to experience persistent chronic pain 3 to 5 years later. In addition, children with symptomatic GJH can experience functional impairments such as difficulties with motor development, and impaired proprioception. Overall symptomatic GJH may negatively impact a child’s participation, including school attendance, poor academic performance, reduced quality of life and psychosocial function.

To date no study has investigated the impact of custom-made orthotics on pain, functioning, fatigue and quality of life in children with GJH and lower limb pain. This study therefore investigated the safety of and outcomes following custom-made orthotic use with podiatric recommended footwear in children with GJH and lower limb pain through before and after assessment of pain, functioning, fatigue and quality of life over a three-month period.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Muhammad Maarj

Address

MP Building, office: 214, University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258

Country

Australia

Phone

+61477075851

Fax

muhammad.maarj@uon.edu.au

Contact person for public queries

Name

Muhammad Maarj

Address

MP Building, office: 214, University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258

Country

Australia

Phone

+61477075851

Fax

muhammad.maarj@uon.edu.au

Contact person for scientific queries

Name

Muhammad Maarj

Address

MP Building, office: 214, University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258

Country

Australia

Phone

+61477075851

Fax

muhammad.maarj@uon.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?

All published data can be shared

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

From January 1st 2024 to January 1st 2025

Available to whom?

Qualified researchers engaging in independent scientific research

Available for what types of analyses?

Systematic reviews

How or where can data be obtained?

Contact the principal investigator via email.
Muhammad Maarj
muhammad.maarj@uon.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19429	Ethical approval			muhammad.maarj@uon.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Impact of Podiatric Intervention on the Quality of Life and Pain in Children and Adolescents with Hypermobility.	2023	https://dx.doi.org/10.3390/ijerph20176623

N.B. These documents automatically identified may not have been verified by the study sponsor.

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