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Trial registered on ANZCTR


Registration number
ACTRN12616001118493
Ethics application status
Approved
Date submitted
28/07/2016
Date registered
17/08/2016
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do customised fit shoes increase physical activity in children with Down syndrome?
Scientific title
A pilot randomised controlled trial to investigate if customised fit shoes increase the amount of physical activity performed by children and adolescents with Down syndrome
Secondary ID [1] 289727 0
None
Universal Trial Number (UTN)
Trial acronym
ShoeFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity in Down syndrome 299570 0
Foot health in Down syndrome 299571 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299542 299542 0 0
Other physical medicine / rehabilitation
Human Genetics and Inherited Disorders 299634 299634 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive two pairs of standard commerically available shoes (from Clarks Australia); one pair for school and one pair for ordinary wear. The shoes will be custom fitted during a single one-on-one appointment (approximate duration of 1 hour) with a podiatrist trained in fitting shoes. The school shoes will be Clarks Laura (females) or Lochie (males) model shoes. Participants that have feet that are too large for the Laura/Lochie styles or prefer lace-up shoes will be provided with Daytona model shoes. Ordinary wear shoes will be Clarks Ventura model (males and females) shoes. Participants that prefer lace-up shoes will be provided with Vancouver model shoes.

The duration of the intervention will be 12 weeks. Participants will be expected to use the school shoes when they go to school and use the ordinary wear shoes at other times (i.e. when they are not at school but are wearing shoes).

Adherence will be monitored by specially designed questionnaire that the parents will complete at 6 and 12 weeks.
Intervention code [1] 295365 0
Treatment: Other
Intervention code [2] 295463 0
Lifestyle
Intervention code [3] 295636 0
Treatment: Devices
Comparator / control treatment
The control group (wait list control) will continue wearing their existing shoes and will then receive two pairs of customised fit shoes at the end of the study (12 weeks).
Control group
Active

Outcomes
Primary outcome [1] 299019 0
Physical activity (using an Actigraph activity monitor collected over 7 days)
Timepoint [1] 299019 0
Baseline and at 6 and 12 weeks. Twelve weeks is the primary end-point
Secondary outcome [1] 325878 0
Foot-specific disability (physical domain) using the physical domain of the Oxford Ankle Foot Questionnaire for Children) - parent reported version
Timepoint [1] 325878 0
Baseline, 6 and 12 weeks
Secondary outcome [2] 325880 0
Foot-specific disability (school and play domain) using the Oxford Ankle Foot Questionnaire for Children - parent reported version
Timepoint [2] 325880 0
Baseline, 6 and 12 weeks
Secondary outcome [3] 325883 0
Foot-specific disability (emotional domain) using the Oxford Ankle Foot Questionnaire for Children - parent reported version
Timepoint [3] 325883 0
Baseline, 6 and 12 weeks
Secondary outcome [4] 325884 0
Acceptability of the custom fit shoes (experimental group) via semi-structured interview of the participants and carers/parents
Timepoint [4] 325884 0
12 weeks
Secondary outcome [5] 325896 0
Walking velocity (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [5] 325896 0
Baseline and 12 weeks
Secondary outcome [6] 325897 0
Cadence (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [6] 325897 0
Baseline and 12 weeks
Secondary outcome [7] 325898 0
Stride length (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [7] 325898 0
Baseline and 12 weeks
Secondary outcome [8] 325899 0
Step length (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [8] 325899 0
Baseline and 12 weeks
Secondary outcome [9] 325964 0
Base of support (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [9] 325964 0
Baseline and 12 weeks
Secondary outcome [10] 325965 0
Toe in/out angle (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [10] 325965 0
Baseline and 12 weeks
Secondary outcome [11] 325966 0
Step width (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [11] 325966 0
Baseline and 12 weeks
Secondary outcome [12] 326111 0
Adverse events (such as new pains in the body, rolled ankles, blisters, swelling) will be assessed via survey completed by the parents/next of kin. The survey has been specifically designed for this study.
Timepoint [12] 326111 0
6 and 12 weeks
Secondary outcome [13] 326112 0
Adherence to the intervention (experimental group only) will be determined by survey of parents/next of kin. Parents of the participants will provide information regarding the number of hours per day and number of days they have worn their shoes during the previous 6 weeks. The survey has been specifically designed for this study.
Timepoint [13] 326112 0
6 and 12 weeks
Secondary outcome [14] 326113 0
Use of co-interventions (such as new shoes that have not been prescribed in this study, visits to health care providers for treatment of any foot conditions) will be assessed via a survey. The survey has been specifically designed for this study.
Timepoint [14] 326113 0
6 and 12 weeks
Secondary outcome [15] 326775 0
Stride width (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [15] 326775 0
Baseline and 12 weeks
Secondary outcome [16] 326776 0
Single leg support time (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [16] 326776 0
Baseline and 12 weeks
Secondary outcome [17] 326777 0
Double leg support time (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [17] 326777 0
Baseline and 12 weeks
Secondary outcome [18] 326778 0
Stance time (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [18] 326778 0
Baseline and 12 weeks
Secondary outcome [19] 326779 0
Step time (using the GAITRite system) wearing the pre-study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Timepoint [19] 326779 0
Baseline and 12 weeks

Eligibility
Key inclusion criteria
Children and adolescents with Down syndrome will be eligible for inclusion in the trial if they are aged between 5 and 17 years and have the ability to follow simple verbal instructions in English.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the trial if there is an acute or subacute medical reason why their physical activity levels might be affected on an on-going basis (e.g. previous lower limb surgery, unable to walk without a supportive device such as a walker or brace), or a concomitant medical condition or injury that could affect their physical function (e.g. neurological or inflammatory disorder). Participants will also be excluded from the trial after the initial assessment if they cannot adhere to wearing a monitor to measure the amount of physical activity they do for at least 10 hours on at least 4 days including at least one weekend day.

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)
Participants will be randomly allocated to one of two groups after baseline assessment using sealed opaque envelopes. The sealed envelopes will be prepared beforehand by a researcher with no other involvement in participant recruitment, allocation or assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (with random block sizes)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be completed using SPSS (IBM Corp, NY, USA). Demographic characteristics and baseline data will be summarized by descriptive statistics.

Data on outcome measures will be analysed on an intention-to-treat basis. Multiple imputation will be used to replace any missing data using five iterations, with age, baseline scores, and group allocation as predictors.

Groups will be compared on primary and secondary outcomes at week 6 and 12. Continuously-scored outcome measures will be analysed using analysis of covariance with the intervention group and baseline scores entered as independent variables. Effect sizes and associated 95% confidence intervals will be calculated for each outcome. A sample size calculation for a fully powered randomised controlled trial will also be completed.

Acceptability data from semi-structured interviews will be analysed using thematic analysis by two independent assessors and final themes will be agreed by consensus.

Statistical significance for hypothesis tests will be set at the conventional level of a = 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2016
Actual
21/09/2016
Date of last participant enrolment
Anticipated
29/09/2017
Actual
8/09/2017
Date of last data collection
Anticipated
22/12/2017
Actual
20/12/2017
Sample size
Target
30
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294121 0
University
Name [1] 294121 0
La Trobe University. Sport, Exercise and Rehabilitation Research Focus Area Grant Scheme 1 – Pilot Project
Country [1] 294121 0
Australia
Primary sponsor type
Individual
Name
Shannon Munteanu
Address
School of Allied Health,
La Trobe University,
Melbourne VIC 3086
Country
Australia
Secondary sponsor category [1] 292949 0
Individual
Name [1] 292949 0
Nora Shields
Address [1] 292949 0
School of Allied Health,
La Trobe University,
Melbourne VIC 3086
Country [1] 292949 0
Australia
Other collaborator category [1] 279092 0
Individual
Name [1] 279092 0
Hylton Menz
Address [1] 279092 0
School of Allied Health,
La Trobe University,
Melbourne VIC 3086
Country [1] 279092 0
Australia
Other collaborator category [2] 279093 0
Individual
Name [2] 279093 0
Nicholas Taylor
Address [2] 279093 0
School of Allied Health,
La Trobe University,
Melbourne VIC 3086
Country [2] 279093 0
Australia
Other collaborator category [3] 279094 0
Individual
Name [3] 279094 0
Angela Evans
Address [3] 279094 0
School of Allied Health,
La Trobe University,
Melbourne VIC 3086
Country [3] 279094 0
Australia
Other collaborator category [4] 279095 0
Individual
Name [4] 279095 0
Cylie Williams
Address [4] 279095 0
Faculty of Medicine, Nursing & Health Sciences,
Monash University,
Wellington Rd & Blackburn Rd,
Clayton VIC 3800
Country [4] 279095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295527 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 295527 0
Ethics committee country [1] 295527 0
Australia
Date submitted for ethics approval [1] 295527 0
30/03/2016
Approval date [1] 295527 0
19/05/2016
Ethics approval number [1] 295527 0
HEC16-027

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

Contacts
Principal investigator
Name 67606 0
Dr Shannon Munteanu
Address 67606 0
School of Allied Health,
La Trobe University
Melbourne
VIC 3086
Country 67606 0
Australia
Phone 67606 0
+61 3 94795866
Fax 67606 0
Email 67606 0
[email protected]
Contact person for public queries
Name 67607 0
Shannon Munteanu
Address 67607 0
School of Allied Health,
La Trobe University
Melbourne
VIC 3086
Country 67607 0
Australia
Phone 67607 0
+61 3 94795866
Fax 67607 0
Email 67607 0
[email protected]
Contact person for scientific queries
Name 67608 0
Shannon Munteanu
Address 67608 0
School of Allied Health,
La Trobe University
Melbourne
VIC 3086
Country 67608 0
Australia
Phone 67608 0
+61 3 94795866
Fax 67608 0
Email 67608 0
[email protected]

No information has been provided regarding IPD availability


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.