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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] 309927 0
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 330338 0
Condition category
Condition code
Musculoskeletal 327186 327186 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 327244 327244 0 0
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] 326304 0
Treatment: Devices
Intervention code [2] 326305 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335065 0
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] 335065 0
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] 335066 0
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] 335066 0
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.
Secondary outcome [1] 422898 0
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] 422898 0
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.
Secondary outcome [2] 422899 0
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] 422899 0
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.
Secondary outcome [3] 422900 0
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] 422900 0
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?
No
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
50
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24895 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 40545 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 314065 0
Charities/Societies/Foundations
Name [1] 314065 0
ConnecTeD Foundation
Country [1] 314065 0
Australia
Primary sponsor type
University
Name
Newcastle University
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315970 0
None
Name [1] 315970 0
Address [1] 315970 0
Country [1] 315970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313203 0
Executive Committee of the Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 313203 0
Corner Hawkesbury Road and Hainsworth Street, Westmead 2145 NSW
Ethics committee country [1] 313203 0
Australia
Date submitted for ethics approval [1] 313203 0
30/10/2018
Approval date [1] 313203 0
14/03/2019
Ethics approval number [1] 313203 0
LNR/18/SCHN/480
Ethics committee name [2] 313205 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 313205 0
Research Integrity Unit
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [2] 313205 0
Australia
Date submitted for ethics approval [2] 313205 0
01/07/2019
Approval date [2] 313205 0
04/07/2019
Ethics approval number [2] 313205 0
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 127330 0
Mr Muhammad Maarj
Address 127330 0
MP Building, office: 214, University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258
Country 127330 0
Australia
Phone 127330 0
+61477075851
Fax 127330 0
Email 127330 0
[email protected]
Contact person for public queries
Name 127331 0
Muhammad Maarj
Address 127331 0
MP Building, office: 214, University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258
Country 127331 0
Australia
Phone 127331 0
+61477075851
Fax 127331 0
Email 127331 0
[email protected]
Contact person for scientific queries
Name 127332 0
Muhammad Maarj
Address 127332 0
MP Building, office: 214, University of Newcastle, 10 Chittaway Rd, Ourimbah NSW 2258
Country 127332 0
Australia
Phone 127332 0
+61477075851
Fax 127332 0
Email 127332 0
[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?
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
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19429Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Impact of Podiatric Intervention on the Quality of Life and Pain in Children and Adolescents with Hypermobility.2023https://dx.doi.org/10.3390/ijerph20176623
N.B. These documents automatically identified may not have been verified by the study sponsor.