Textured insoles may improve some gross motor balance measures but not endurance measures in children with motor coordination issues. A randomised controlled feasibility trial.

Background: Motor coordination concerns are estimated to affect 5%-6% of school-aged children. Motor coordination concerns have variable impact on children's lives, with gait and balance often affected. Textured insoles have demonstrated positive impact on balance and gait in adults with motor coordination disorders related to disease or the ageing process. The efficacy of textured insoles in children is unknown. Our primary aim was to identify the feasibility of conducting a randomised controlled trial involving children with motor control issues. The secondary aim was to identify the limited efficacy of textured insoles on gross motor assessment balance domains and endurance in children with movement difficulties.

Methods: An assessor-blinded, randomised feasibility study. We advertised for children between the ages of 5-12 years, with an existing diagnosis or developmental coordination disorder or gross motor skill levels assessed as 15th percentile or below on a norm-referenced, reliable and validated scale across two cities within Australia. We randomly allocated children to shoes only or shoes and textured insoles. We collected data across six feasibility domains; demand (recruitment), acceptability (via interview) implementation (adherence), practicality (via interview and adverse events), adaptation (via interview) and limited efficacy testing (6-min walk test and balance domain of Movement ABC-2 at baseline and 4 weeks).

Results: There were 15 children randomised into two groups (eight received shoes alone, seven received shoes and textured insoles). We experienced moderate demand, with 46 potential participants. The insoles were acceptable, however, some parents reported footwear fixture issues requiring modification. The 6-min walk test was described as problematic for children, despite all but one child completing. Social factors impacted adherence and footwear wear time in both groups. Families reported appointment locations and parking impacting practicality. Underpowered, non-significant small to moderate effect sizes were observed for different outcome measures. Improvement in balance measures favoured the shoe and insole group, while gait velocity increase favoured the shoe only group.

Conclusion: Our research indicates that this trial design is feasible with modifications such as recruiting with a larger multi-disciplinary organisation, providing velcro shoe fixtures and using a shorter timed walk test. Furthermore, progressing to a larger well-powered randomised control trial is justified considering our preliminary, albeit underpowered, efficacy findings.

Trial registration: This trial was retrospectively registered with the Australian and New Zealand Clinical Trial Registration: ACTRN12624000160538.