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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?
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Scientific title
Can textured insoles reduce the amount of toe walking in children who toe walk? A randomised controlled feasibility trial.
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Secondary ID [1]
312467
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
toe walking
334302
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gait impairment
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Condition category
Condition code
Musculoskeletal
330959
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328977
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Administration related to recruitment opportunities will identify demand. Potential engagement will be determined by the number of queries received regarding the study, as documented by administrative support (e.g., a headcount of phone enquiries), and eligibility of those queries as screened by the chief investigator (with reasons for exclusion recorded where relevant) determining actual demand.
A participant diary filled in weekly between the baseline and the follow up assessment will document the number of hours per day wearing the footwear and ask questions regarding comfort. The diary will obtain self-reported measures of Implementation, Acceptability and Adaptation. Participants will be asked to document daily hours of wear (Implementation), any adverse events (Acceptability), reasons for not wearing footwear where relevant (Adaptation), and weekly perceptions of comfort (Acceptability) and perceived changes in toe walking on a VAS 10mm scale (Adaptation).
A semi-structured telephone interview with parents/carers will obtain measures of Acceptability, Practicality and Adaptation two weeks post intervention. Questions include; Acceptability: ‘From your perspective, were there any issues or concerns with getting your child to wear the shoes +/- insole – comparing them to a normal experience of getting shoes on?’ Adaptation: ‘Do you think there has been any changes in your child’s toe walking before getting the shoes/insoles, do you think there has been any differences between then and what you have seen over the past 4 months?’ and ‘Thinking about your child’s movement/balance in activities before getting the shoes/insoles, do you think there has been any differences between then and what you’ve seen over the 4 months?’ Practicality: ‘How did you feel about participating in the study, what was convenient, what was inconvenient.’
Interviews will be audio recorded with consent, transcribed verbatim and themed by consensus of the authorship group.
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Timepoint [1]
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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.
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Primary outcome [2]
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Clinician assessed outcome measures will identify changes in toe walking height to identify limited efficacy.
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Assessment method [2]
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A change in heel height during walking will be measured using the 3D motion capture using the HR32 measure. This measure has been shown to be a valuable measure to identify a toe walking pattern. 3 markers will be positioned on the participants shoe (on the back of the heel, lateral malleolus and dorsal forefoot). Care will be taken to ensure each marker is placed in the same location on the shoes. Participants will be asked to walk at their self selected comfortable speed along a 10m walkway for up 10 trials.
Participants will be allowed to rest as needed during any of the gait trials. It is recognised that children will often change their gait in a clinical environment. Therefore, during all gait trials, the participants will be required to complete a finger-thumb motor apposition task in order to minimise the self-correction of the gait pattern. This task has been shown to challenge neurotypical children who have autism spectrum disorder. It is anticipated that the finger-thumb motor apposition task will sufficiently challenge the child's attention, minimising self-correction of their gait pattern.
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Timepoint [2]
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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.
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Primary outcome [3]
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A change in gait characteristics will be used to identify limited efficacy.
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Assessment method [3]
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A change in spatiotemporal characteristics will be investigated using the GaitRite system™ measuring footstrike characteristics. The GaitRite system™ is a 5m long electronic sensorised walkway placed within a 10m long walkway, with excellent reliability in children. Each participant will be asked to walk at a self selected comfortable speed for up to 10 trials (shoes only or shoes plus insole). The sensorised walkway will record each foot strike and measure features of the pattern of foot strikes of each participants gait (walking speed, cadence, stride and step length, step width, time in single and double leg support).
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Timepoint [3]
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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.
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Secondary outcome [1]
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A change in balance (postural sway) will be used to identify limited efficacy. This is an additional primary outcome.
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Assessment method [1]
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Participant’s balance will be measured standing in hip width relaxed standing on a force plate (AMTI OR-6-7, Watertown, MA, USA). The force platform will record the trajectory of the centre of pressure under the feet which will be used to quantify the amount of postural sway (anteroposterior and mediolateral) displayed by each participant. Each participant will complete 5 x 30 second open eye balance trials and 5 x 30 second closed eye balance trials.
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Timepoint [1]
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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.
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Secondary outcome [2]
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Clinician assessed outcome measures will identify changes in endurance to identify limited efficacy. This is an additional primary outcome.
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Assessment method [2]
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Changes in the 2 minute walk test (2MWT) distance will capture changes in endurance. The 2MWT is a valid and reliable measure of endurance, with known normative data in typically developing children and children with neuromuscular disorders including cerebral palsy. The 2MWT asks participants to walk as far as they can (without jogging or running) along a designated clear pathway for two-minutes. This assessment will be conducted over a 15m circuit, along a clear and hard surface as per recommended instructions
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Timepoint [2]
438110
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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.
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Secondary outcome [3]
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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.
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Assessment method [3]
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The iTWO proforma is a composite tool consisting of parents reported measures, child reported measures and functional assessments and is recommended for use in children who toe-walk. The tool includes:
Parent reported measures:
Estimate how much time your child spent toe walking in the last day or week (measured as a percentage between 0-100%).
How satisfied are you with this amount of toe walking? (measured on a 0-10 likert scale)
Child reported measures (measured using the Wong Baker Faces pain scale or the VAS scale):
What is the worst pain you get in your legs today?
What is the worst pain you get when moving about in the past week?
Functional assessments:
Ankle joint range of motion: Weight bearing lunge with knee bent and knee extended measured using the tiltmeter app.
Walking assessment with heels down (ask the child): ‘Can you try to walk on your heels for 10 steps with your feet in a typical distance apart and trying not to change your body position’. This is a clinical measure frequently used for toe walkers, however, has not been tested for reliability or validity.
2 minute walk test (2MWT) - described in previous outcome measure.
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Timepoint [3]
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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.
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Secondary outcome [4]
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A change in balance will be used to identify limited efficacy. This is an additional primary outcome.
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Assessment method [4]
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Movement Assessment Battery for Children, 2nd Edition
The Movement ABC-2 Assessment Battery for Children, 2nd edition balance domain will be conducted as it is a reliable and valid measure of motor skills in children. The balance domain includes one static measure of balance and two dynamic measures, applied in age-appropriate 'bands' and will be conducted in accordance to manufacturers instruction.
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Timepoint [4]
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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.
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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).
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Minimum age
4
Years
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Maximum age
14
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/09/2024
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Actual
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Date of last participant enrolment
Anticipated
10/02/2025
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Actual
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Date of last data collection
Anticipated
7/04/2025
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The Hospital Research Foundation
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Flinders Foundation
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Address [2]
317081
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Country [2]
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Australia
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Primary sponsor type
Hospital
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Name
Southern Adelaide Local Health Network
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
319338
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Women's and Children's Health Network Human Research Ethics Committee
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Ethics committee address [1]
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https://www.wchn.sa.gov.au/research/human-research
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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21/06/2024
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Approval date [1]
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25/06/2024
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Ethics approval number [1]
315642
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Nicole Marshall
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Address
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Flinders Medical Centre, Flinders Drive, BEDFORD PARK, S.A, 5042.
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Country
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Australia
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Phone
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+61 08 8384 9233
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Nicole Marshall
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Address
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Flinders Medical Centre, Flinders Drive, BEDFORD PARK, S.A, 5042.
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Country
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Australia
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Phone
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+61 08 8384 9233
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Nicole Marshall
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Address
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Flinders Medical Centre, Flinders Drive, BEDFORD PARK, S.A, 5042.
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Country
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Australia
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Phone
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+61 08 8384 9233
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Fax
135360
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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