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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000688684
Enrollment
53
Registered
2023-06-26
Start date
2020-01-22
Completion date
2023-01-17
Last updated
2023-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 de

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)

Sponsors

Newcastle University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026