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Trial registered on ANZCTR


Registration number
ACTRN12624001035516
Ethics application status
Approved
Date submitted
5/07/2024
Date registered
27/08/2024
Date last updated
27/08/2024
Date data sharing statement initially provided
27/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can textured insoles reduce the amount of toe walking in children?
Scientific title
Can textured insoles reduce the amount of toe walking in children who toe walk? A randomised controlled feasibility trial.
Secondary ID [1] 312467 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
toe walking 334302 0
gait impairment 334303 0
Condition category
Condition code
Musculoskeletal 330959 330959 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328977 0
Treatment: Devices
Comparator / control treatment
The control group will receive standardised ASICS Contend sneakers alone and asked to wear them as they would their existing footwear. Shoes 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 shoes if relevant. The diary will also ask for a perception of shoe comfort and changes in activity levels across 16 weeks of use, using a VAS 10mm scale.
Control group
Active

Outcomes
Primary outcome [1] 338727 0
Primary assessment will seek feasibility of the trial, based on six domains of Bowen's feasibility framework (Implementation, Acceptability, Adaptation, Practicality, Demand and Limited efficacy) (Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, et al. How we design feasibility studies. Am J Prev Med. 2009;36(5):452-7.), using qualitative and quantitative data associated with the domains obtained via four means; participant diaries, administration related to recruitment opportunities, clinician-assessed outcome measures, and a semi-structured telephone interview with parents/caregivers conducted two weeks post-trial completion.
Timepoint [1] 338727 0
Demand will be assessed at the conclusion of the study. Participant diaries will be filled in weekly between the baseline (dispense of footwear) and the follow up assessment (16 weeks after dispense). Acceptability interviews with families will be conducted two weeks post-intervention completion.
Primary outcome [2] 339154 0
Clinician assessed outcome measures will identify changes in toe walking height to identify limited efficacy.
Timepoint [2] 339154 0
This will be assessed at baseline, midpoint (8 weeks post dispense) and endpoint (16 weeks post dispense) with changes between baseline (timepoint 1) and end point (timepoint 3) being the primary measure of interest.
Primary outcome [3] 339155 0
A change in gait characteristics will be used to identify limited efficacy.
Timepoint [3] 339155 0
This will be assessed at baseline, midpoint (8 weeks post dispense) and endpoint (16 weeks post dispense) with changes between baseline (timepoint 1) and end point (timepoint 3) being the primary measure of interest.
Secondary outcome [1] 438106 0
A change in balance (postural sway) will be used to identify limited efficacy. This is an additional primary outcome.
Timepoint [1] 438106 0
This will be assessed at baseline, midpoint (8 weeks post dispense) and endpoint (16 weeks post dispense) with changes between baseline (timepoint 1) and end point (timepoint 3) being the primary measure of interest.
Secondary outcome [2] 438110 0
Clinician assessed outcome measures will identify changes in endurance to identify limited efficacy. This is an additional primary outcome.
Timepoint [2] 438110 0
This will be assessed at baseline, midpoint (8 weeks post dispense) and endpoint (16 weeks post dispense) with changes between baseline (timepoint 1) and end point (timepoint 3) being the primary measure of interest.
Secondary outcome [3] 438111 0
Changes in qualitative and quantitative responses reported in 'The iTWO Toe Walking Proforma' is a clinical measure for use in children who toe walk to determine limited efficacy. This is an additional primary outcome.
Timepoint [3] 438111 0
This will be assessed at baseline, midpoint (8 weeks post dispense) and endpoint (16 weeks post dispense) with changes between baseline (timepoint 1) and end point (timepoint 3) being the primary measure of interest.
Secondary outcome [4] 438320 0
A change in balance will be used to identify limited efficacy. This is an additional primary outcome.
Timepoint [4] 438320 0
This will be assessed at baseline, midpoint (8 weeks post dispense) and endpoint (16 weeks post dispense) with changes between baseline (timepoint 1) and end point (timepoint 3) being the primary measure of interest.

Eligibility
Key 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).
Minimum age
4 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be conducted via computer generated randomisation program, with the resultant excel file only available to the researchers/clinicians who are supplying and fitting the footwear as allocated.
These researchers/clinicians will not be involved in measuring outcomes post dispense of footwear.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative outcomes associated with the feasibility domains of Demand, Acceptability, Implementation and Adaptation will be considered strong if they exceeded or were within 10% of the recruitment target (Demand) or the mean of the shoe group outcomes (Acceptability, Implementation, Adaptation, Limited efficacy) respectively, moderate if they are within 30% of the measures, and low for all other outcomes. Changes in self-reported comfort, wear time and activity levels will be explored using independent, two-tailed t-tests. Differences between baseline and follow up measures will be compared using a mixed between-within ANOVA, with partial eta squared to identify effect size change, interpreted as greater than or equal to 0.01 = small effect, greater than or equal to 0.06 = moderate effect, greater than or equal to 0.014 = large effect. A post hoc power analysis will be performed retrospectively for dependent variables via G*Power with statistical significance set at less than 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
10/02/2025
Actual
Date of last data collection
Anticipated
7/04/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316882 0
Charities/Societies/Foundations
Name [1] 316882 0
The Hospital Research Foundation
Country [1] 316882 0
Australia
Funding source category [2] 317081 0
Charities/Societies/Foundations
Name [2] 317081 0
Flinders Foundation
Country [2] 317081 0
Australia
Primary sponsor type
Hospital
Name
Southern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 319338 0
None
Name [1] 319338 0
Address [1] 319338 0
Country [1] 319338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315642 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 315642 0
https://www.wchn.sa.gov.au/research/human-research
Ethics committee country [1] 315642 0
Australia
Date submitted for ethics approval [1] 315642 0
21/06/2024
Approval date [1] 315642 0
25/06/2024
Ethics approval number [1] 315642 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135358 0
Miss Nicole Marshall
Address 135358 0
Flinders Medical Centre, Flinders Drive, BEDFORD PARK, S.A, 5042.
Country 135358 0
Australia
Phone 135358 0
+61 08 8384 9233
Fax 135358 0
Email 135358 0
[email protected]
Contact person for public queries
Name 135359 0
Nicole Marshall
Address 135359 0
Flinders Medical Centre, Flinders Drive, BEDFORD PARK, S.A, 5042.
Country 135359 0
Australia
Phone 135359 0
+61 08 8384 9233
Fax 135359 0
Email 135359 0
[email protected]
Contact person for scientific queries
Name 135360 0
Nicole Marshall
Address 135360 0
Flinders Medical Centre, Flinders Drive, BEDFORD PARK, S.A, 5042.
Country 135360 0
Australia
Phone 135360 0
+61 08 8384 9233
Fax 135360 0
Email 135360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.