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Can textured insoles reduce the amount of toe walking in children?

Can textured insoles reduce the amount of toe walking in children who toe walk? A randomised controlled feasibility trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001035516
Enrollment
40
Registered
2024-08-27
Start date
2024-09-16
Completion date
2025-02-10
Last updated
2024-09-02

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

Conditions

None listed

Brief summary

Toe walking occurs in 5% of all children and 20% of children with autism spectrum disorder. It can result in foot and lower leg pain, contribute to falls and even bullying. Current treatment methods are time consuming, uncomfortable and ineffective. Textured insoles have shown to improve balance in children and adults. We do not know if either shoes or a textured insole will help children who toe walk. We are recruiting children aged 4 to 14 years who toe walk for no known reason or for sensory reasons to investigate if we can improve the amount or height of toe walking, balance or walking speed with the use of supportive sneakers with or without Naboso insoles. We are also determining the feasibility of the study and whether it can be conducted on a larger group of children

Interventions

The intervention group will receive ASICS Contend sneakers with a Naboso Activation insole fitted and asked to wear them as they would their existing footwear. Insoles and shoes [footwear] will be fitted by an experienced paediatric podiatrist dispensed with participants asked to wear them 'as they "normally" would wear new shoes'. Participants will be supplied a paper or electronic diary and asked to record the hours of wear per day and any adverse effects experienced, or reasons for not wearin

The intervention group will receive ASICS Contend sneakers with a Naboso Activation insole fitted and asked to wear them as they would their existing footwear. Insoles and shoes [footwear] will be fitted by an experienced paediatric podiatrist dispensed with participants asked to wear them 'as they "normally" would wear new shoes'. Participants will be supplied a paper or electronic diary and asked to record the hours of wear per day and any adverse effects experienced, or reasons for not wearing footwear if relevant. The diary asks for a perception of footwear comfort and changes in activity levels across 16 weeks of use, using a VAS 10mm scale.

Sponsors

Southern Adelaide Local Health Network
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

Children aged 4 – 14 years, bilateral toe walking gait, can achieve plantargrade foot position in stance (i.e heels can touch the floor), foot shape and size can be accommodated into standardised shoes (do not need customised footwear).

Exclusion criteria

Spastic, inflammatory or traumatic condition impacting the lower limbs, history of achilles lengthening surgical procedure, communication or processing concerns that impacts on ability to verbally communicate with researchers and follow simple instructions, previous Botulim Type A Toxin Treatment, no active treatment for toe walking in the last 3 months (e.g. serial casting, orthoses, exercises for toe walking).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026