Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000999336
Ethics application status
Approved
Date submitted
5/07/2017
Date registered
11/07/2017
Date last updated
28/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding the impact of footwear on young children's gait
Scientific title
Understanding the impact of sole hardness and footwear design parameters on young children's gait
Secondary ID [1] 292364 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric foot development 303909 0
Condition category
Condition code
Musculoskeletal 303274 303274 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate the acute impact of different footwear and footwear features on gait of 2, 3 and 4 year old children. These exposures include boots, sandals, and runners in a soft sole and hard sole to determine the differences between each of the footwear and barefoot as measured on the GAITRite ('Registered Trademark) system. A selection of children will also wear a Trigno EMG Systems for Electromyography (EMG) sensor at the lateral gastrocnemius, biceps femoris and lateral branch of the rectus femoris.

Shoes were selected as commonly wore footwear by children during the different seasons and play. All shoes will have the same features for each participant. The runners have a firm heel counter, and velcro fasteners. The boots are above the ankle, have a zip at the inside and elastic on the outside to assist in fitting and the sandals have velcro strap fixture, enclosed heel and open toe.

Seven conditions will be tested- 1. Barefoot (no footwear) 2. Sandals (Hard sole) 3. Sandals (Soft sole) , 4. Runners (Hard sole), 5. Runners (Soft soles), 6 Boots (Hard sole) and 7. Boot (Soft sole), will be used and the immediate effect on gait will be measured. Each condition consists of three walking trials and three running trials along the GaitRite mat, which is four (4) metres in length. During recording, if the initial or final contact is a partial foot fall, due to the potential for the foot to strike the mat in a partial sensor area, this data will be excluded. All other contacts within the recording, will be recorded for analysis. A one metre space will be provided at each end of the mat to allow the children to accelerate and decelerate as required.

Conditions are as follows: Condition 1: After familiarisation, the child will be asked to remove their footwear and walk along the GAITRite('Registered Trademark) mat at their preferred pace for 3 passes. Then the child will be asked to run as fast as they can for three passes.

Conditions 2-7: The children will be placed in socks and the footwear of interest while walking along the GAITRite('Registered Trademark) mat. The child will then repeat the trial running at their select selected fastest.

A randomization procedure by use of a Latin square design will be employed for the seven conditions. Between each of these conditions, there is not anticipated to be a washout period and there will be 5 minutes between each testing period.
I.e.:
Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7
Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 1
Condition 3, Condition 4, Condition 5, Condition 6, Condition 7 Condition 1, Condition 2
etc

The first five children in each age group will wear the Trigno surface EMG during testing.
Intervention code [1] 298537 0
Treatment: Devices
Comparator / control treatment
Comparator is the barefoot condition and all other conditions will be compared to the data obained from this condition.
Control group
Active

Outcomes
Primary outcome [1] 302657 0
Differences gait velocity assessed by GaitRite system
Timepoint [1] 302657 0
Time of testing during one session only
Primary outcome [2] 302677 0
Differences in gait cadence as measured by the Gaitrite system.
Timepoint [2] 302677 0
Time of testing during one session only
Primary outcome [3] 302678 0
Differences in stride length as measured with the Gaitrite system
Timepoint [3] 302678 0
Time of testing during one session only
Secondary outcome [1] 336685 0
Differences in muscle activity of the gastrocnemius between conditions as measured with the Trigno.
Timepoint [1] 336685 0
Time of testing during one session only
Secondary outcome [2] 336729 0
Differences in step width between conditions as measured with the Gaitrite system
Timepoint [2] 336729 0
Time of testing during one session only
Secondary outcome [3] 336730 0
Differences in the step timing between conditions as measured with the Gaitrite system
Timepoint [3] 336730 0
Time of testing during one session only
Secondary outcome [4] 336731 0
Difference intoe/outtoe angle between conditions as measured with the Gaitrite system
Timepoint [4] 336731 0
Time of testing during one session only
Secondary outcome [5] 336732 0
Difference in stance percentage between conditions as measured with the Gaitrite system
Timepoint [5] 336732 0
Time of testing during one session only
Secondary outcome [6] 336733 0
Difference in swing percentage between conditions as measured with the Gaitrite system
Timepoint [6] 336733 0
Time of testing during one session only
Secondary outcome [7] 336734 0
Difference in double support time between conditions as measured with the Gaitrite system
Timepoint [7] 336734 0
Time of testing during one session only
Secondary outcome [8] 336735 0
Difference in load/unload time between conditions as measured with the Gaitrite system
Timepoint [8] 336735 0
Time of testing during one session only
Secondary outcome [9] 336738 0
Differences in muscle activity of the biceps femoris between conditions as measured with the Trigno.
Timepoint [9] 336738 0
Time of testing during one session only
Secondary outcome [10] 336739 0
Differences in muscle activity of the rectis femoris between conditions as measured with the Trigno.
Timepoint [10] 336739 0
Time of testing during one session only

Eligibility
Key inclusion criteria
Community dwelling children with no known gait or lower limb disorders
Minimum age
2 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who have a medical condition known to influence gait or foot posture will be excluded through parent report. Children will be screened to determine appropriate foot posture and muscle strength prior to testing.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within subject randomised controlled trial with Latin square allocation for all stimuli conditions
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The descriptive statistics will be used to express each variable in means (SD) or frequency (%) for all full foot strikes. Linear regression analyses will be used to determine the difference in outcome measures between the barefoot (condition 1) versus each other condition. The data will be clustered within individual participants and robust variance estimates used to account for the within-subject nature of these data.



Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/07/2017
Date of last participant enrolment
Anticipated
Actual
20/07/2017
Date of last data collection
Anticipated
Actual
20/07/2017
Sample size
Target
45
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16567 0
3199 - Frankston
Recruitment postcode(s) [2] 16568 0
3198 - Seaford
Recruitment postcode(s) [3] 16569 0
3192 - Cheltenham

Funding & Sponsors
Funding source category [1] 296917 0
Commercial sector/Industry
Name [1] 296917 0
Bobux International Pty Ltd
Country [1] 296917 0
New Zealand
Primary sponsor type
University
Name
Monash University
Address
McMahon Road,
Frankston, VIC, 3199
Country
Australia
Secondary sponsor category [1] 295922 0
None
Name [1] 295922 0
Address [1] 295922 0
Country [1] 295922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298126 0
Monash University
Ethics committee address [1] 298126 0
Ethics committee country [1] 298126 0
Australia
Date submitted for ethics approval [1] 298126 0
14/03/2017
Approval date [1] 298126 0
07/06/2017
Ethics approval number [1] 298126 0
2017 - 8549

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

Contacts
Principal investigator
Name 76082 0
Dr Cylie Williams
Address 76082 0
Monash University
Department of Physiotherapy
1 McMahons Rd
Frankston, VIC, 3199
Country 76082 0
Australia
Phone 76082 0
+61 3 9784 2678
Fax 76082 0
Email 76082 0
[email protected]
Contact person for public queries
Name 76083 0
Cylie Williams
Address 76083 0
Monash University
Department of Physiotherapy
1 McMahons Rd
Frankston, VIC, 3199
Country 76083 0
Australia
Phone 76083 0
+61 3 9784 2678
Fax 76083 0
Email 76083 0
[email protected]
Contact person for scientific queries
Name 76084 0
Cylie Williams
Address 76084 0
Monash University
Department of Physiotherapy
1 McMahons Rd
Frankston, VIC, 3199
Country 76084 0
Australia
Phone 76084 0
+61 3 9784 2678
Fax 76084 0
Email 76084 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
SourceTitleYear of PublicationDOI
EmbaseA comparison of young children's spatiotemporal gait measures in three common types of footwear with different sole hardness.2021https://dx.doi.org/10.1016/j.gaitpost.2021.09.165
N.B. These documents automatically identified may not have been verified by the study sponsor.