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Trial registered on ANZCTR


Registration number
ACTRN12624000160538
Ethics application status
Approved
Date submitted
19/01/2024
Date registered
20/02/2024
Date last updated
20/02/2024
Date data sharing statement initially provided
20/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can the use of textured insoles affect the balance or endurance in children with motor coordination concerns?
Scientific title
Evaluations of the use of textured insoles in gross motor balance and endurance in children with motor coordination issues. A randomised controlled feasibility trial.
Secondary ID [1] 311473 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor coordination concerns
 332641 0
gait impairment 332788 0
balance impairment 332789 0
falls risk 332790 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329345 329345 0 0
Other physical medicine / rehabilitation
Musculoskeletal 329510 329510 0 0
Other muscular and skeletal disorders
Neurological 329511 329511 0 0
Other neurological disorders
Injuries and Accidents 329512 329512 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group received ASICS Contend sneakers with a Naboso Activation insole fitted and asked to wear them as they would their existing footwear.
Insoles and shoes [footwear] fitted by an experienced paediatric podiatrist dispensed with participants asked to wear them 'as they "normally" would wear new shoes'. Participants 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 also asked for a perception of footwear comfort and changes in activity levels across 4 weeks of use, using a VAS 10mm scale.
Intervention code [1] 327812 0
Treatment: Devices
Comparator / control treatment
The control group received standardised ASICS Contend sneakers alone and asked to wear them as they would their existing footwear. Shoes fitted by an experienced paediatric podiatrist dispensed with participants asked to wear them 'as they "normally" would wear new shoes'. Participants 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 also asked for a perception of shoe comfort and changes in activity levels across 4 weeks of use, using a VAS 10mm scale.
Control group
Active

Outcomes
Primary outcome [1] 337164 0
Primary outcome was feasibility, based on a composite measure, specifically five domains of Bowen's feasibility framework (Implementation, Acceptability, Adaptation, Practicality, Demand) (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.). Qualitative and quantitative data associated with the domains were obtained via participant diary, semi-structured telephone interviews and administration records.
Timepoint [1] 337164 0
Participant diary was filled in weekly between the baseline (dispense of footwear) and the follow up assessment (four weeks after dispense).
Primary outcome [2] 337307 0
A 10 minute semi-structured telephone interview with parents/carers obtained measures of Acceptability, Practicality and Adaptation.

Questions asked:
1. Were there any issues getting your child to wear the footwear as dispensed (Acceptability)
2. Thinking about your child's movements and participation in activies before getting the footwear as dispensed, do you think there has been any differences (Adaptation)
3. What was convenient about engaging in the trial (Practicality)
4. What was inconvenient about engaging in the trial (Practicality)
5. Is there anything we could do to make it easier for you, or the child, to be involved in this trial (Practicality)
Timepoint [2] 337307 0
Two-weeks post follow up appointment.
Secondary outcome [1] 431409 0
Changes in gross motor balance and endurance were sought to assessment the domain of Limited Efficiency.
Timepoint [1] 431409 0
Assessed at baseline (prior to dispense of footwear) and at follow up (four weeks after dispense).
Secondary outcome [2] 431410 0
Endurance outcomes were based on distance covered during a 6-minute walk test.
Timepoint [2] 431410 0
Assessed at baseline (prior to dispense of footwear) and at follow up (four weeks after dispense).

Eligibility
Key inclusion criteria
Children were eligible to participate in this study if they:
• were aged 5 to 12 years, and
• had an existing diagnosis of DCD or had been assessed on the 15th percentile or below for gross motor skills using a validated and reliable gross motor assessment battery of tests, and
• had not worn foot or leg orthoses in the past six months.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were excluded if they had a disorder or condition that impacted their ability to participate in gross motor assessment or walk for six minutes or more unaided, including significant joint hypermobility that had previously resulted in joint subluxation and/or dislocation, or were unable to verbally communicate with the researchers. All parents or carers provided written consent and children assented prior to participation.

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 was conducted via computer generated randomisation program, with the resultant excel file only available to the researchers/clinicians who were supplying and fitting the footwear as allocated. These researchers/clinicians were not 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The a priori decision was taken to thematically code qualitative data against the Bowen’s framework for feasibility studies (Bowen et al., 2009). This deductive method of analysis allows for statements to be individually aligned with the domains within the framework (Braun & Clarke, 2021).

Changes in self-reported comfort, wear time and activity levels can be explored using independent, two-tailed t-tests (Portney, 2009). Differences between baseline and follow-up measures compared using a mixed between-within ANOVA, with partial eta squared to identify effect size change, interpreted as equal or greater than 0.01 = small effect, equal or greater than 0.06= moderate effect, equal or greater than 0.14 = large effect (Cohen, 2013; Portney, 2009). 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 control group outcomes (Acceptability, Implementation, Adaptation and Limited efficacy) respectively, moderate if they were within 30% and low for all other outcomes. As a novel intervention, sample size calculations can not be estimated, however, a post hoc power analysis will be performed (Faul et al., 2007). Statistical significance is set at less than =0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/08/2022
Date of last participant enrolment
Anticipated
Actual
18/10/2022
Date of last data collection
Anticipated
Actual
22/11/2022
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment postcode(s) [1] 41895 0
5001 - Adelaide
Recruitment postcode(s) [2] 41896 0
3192 - Cheltenham

Funding & Sponsors
Funding source category [1] 315629 0
Charities/Societies/Foundations
Name [1] 315629 0
Australian Podiatry Education and Research Foundation
Country [1] 315629 0
Australia
Primary sponsor type
University
Name
Allied Health and Human Performance, University of South Australia,
Address
Allied Health and Human Performance, North Tce, Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 317726 0
University
Name [1] 317726 0
School of Primary and Allied Health, Monash University.
Address [1] 317726 0
School of Primary and Allied Health, 47-49 Moorooduc Hwy, Frankston, VIC, 3199.
Country [1] 317726 0
Australia
Other collaborator category [1] 282929 0
Commercial sector/Industry
Name [1] 282929 0
Kingston Foot Clinic. Cheltenham, Victoria.
Address [1] 282929 0
6/147 Centre Dandenong Rd, Cheltenham VIC 3192
Country [1] 282929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314513 0
University of South Australia's Human Research Ethics Committee,
Ethics committee address [1] 314513 0
Ethics committee country [1] 314513 0
Australia
Date submitted for ethics approval [1] 314513 0
13/01/2022
Approval date [1] 314513 0
16/02/2022
Ethics approval number [1] 314513 0
204442

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131850 0
Dr Helen Banwell
Address 131850 0
University of South Australia, Allied Health and Human Performance, GPO box 2471, Adelaide 5001
Country 131850 0
Australia
Phone 131850 0
+61883021256
Fax 131850 0
Email 131850 0
helen.banwell@unisa.edu.au
Contact person for public queries
Name 131851 0
Helen Banwell
Address 131851 0
University of South Australia, Allied Health and Human Performance, GPO box 2471, Adelaide 5001
Country 131851 0
Australia
Phone 131851 0
+61883021256
Fax 131851 0
Email 131851 0
helen.banwell@unisa.edu.au
Contact person for scientific queries
Name 131852 0
Helen Banwell
Address 131852 0
University of South Australia, Allied Health and Human Performance, GPO box 2471, Adelaide 5001
Country 131852 0
Australia
Phone 131852 0
+61883021256
Fax 131852 0
Email 131852 0
helen.banwell@unisa.edu.au

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.