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Trial registered on ANZCTR


Registration number
ACTRN12612000975897
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
10/09/2012
Date last updated
22/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does external stimuli impact the gait of children with idiopathic toe walking
Scientific title
Does external stimuli impact the gait of children with idiopathic toe walking
Secondary ID [1] 280123 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Toe Walking 286046 0
Condition category
Condition code
Musculoskeletal 286238 286238 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to investigate the acute impact on gait, of a number of treatment options including footwear, orthotics and whole body vibration stimulation to determine if any one intervention improves heel contact as measured on the GAITRite ('Registered Trademark) system.

Four conditions will be tested- 1. Barefoot (no footwear) 2. Footwear 3. Orthotics and footwear 4. Whole body vibration, will be used and the immediate effect on gait will be measured. Each condition consists of two walking trials along the GaitRite mat, which is 8.3 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, including subsequent partial foot falls from each trial 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. As children can control their idiopathic toe walking with concentration, the children will be asked to complete a verbal cogitative task at the same time. For example, they will be asked to perform a finger thumb apposition.

Condition 2: The children will be placed in socks and the usual footwear worn for everyday athletic activities. The shoe will be laced securely by the research assistant and the children will be asked again to complete a cognitive task (finger thumb apposition) while walking along the GAITRite('Registered Trademark) mat.

Condition 3: A custom made full length carbon fibre orthotic will be placed in the same shoes as those used in Condition 2. The child will then be asked to complete a cognitive task (finger thumb apposition) while walking along the GAITRite ('Registered Trademark) mat.

Condition 4: The acute gait effect of whole body vibration will be measured after the administration of five sets of one minute vibration followed by one minute of rest to the child. The set frequency of 15hz will be used for each child while the child stands in a semi squat position on the machine. The child will be asked to walk along the GAITRite ('Registered Trademark) mat at 1 minute, 5 minute, 10 minute and 20 minutes after the 5 minutes of vibration. All children will be asked to again complete a cognitive task (finger thumb apposition) while walking to minimize their thought of changing their gait pattern.

A randomization procedure by use of a Latin square design will be employed for the first three gait/external stimuli conditions (Condition 1, 2 & 3). Between each of these conditions, there is not anticipated to be a washout period and there will be 5 minutes between each testing period.

Condition 4 will be conducted at the end of the randomized conditions as it involves whole body vibration and there is potential for residual effects. The randomisation will be conducted in the following pattern with participants ensuring each of the three conditions are randomised. As it is unknown what impact or wash out affect condition 4 may give, it has not been included in the randomisation.
Condition 1, Condition 2, Condition 3, Condition 4
Condition 2, Condition 3, Condition 1, Condition 4
Condition 3, Condition 1, Condition 2, Condition 4
Intervention code [1] 284455 0
Treatment: Devices
Intervention code [2] 285661 0
Treatment: Other
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] 286710 0
GaitRite data produced with each intervention will include:

1. Heel contact pre and post interventions will be measured
Timepoint [1] 286710 0
Time of testing during one session only
Secondary outcome [1] 296508 0
Step time using the GaitRite system
Timepoint [1] 296508 0
Time of testing during one session only
Secondary outcome [2] 299112 0
Velocity using the GaitRite system
Timepoint [2] 299112 0
Time of testing during one session only
Secondary outcome [3] 299113 0
Stride length using the GaitRite system
Timepoint [3] 299113 0
Time of testing during one session only
Secondary outcome [4] 299114 0
Foot progression angle using the GaitRite system
Timepoint [4] 299114 0
Time of testing during one session only
Secondary outcome [5] 299152 0
Available ankle range of motion tested with the weight bearing lunge test
Timepoint [5] 299152 0
Weight bearing lunge test will be conducted prior to each condition testing

Eligibility
Key inclusion criteria
- Children diagnosed with ITW by multidisciplinary assessment within Toe Walking Clinic of Monash Childrens
- Children between the ages of 4-10 years of age
- Children who are able to heel toe walk on request and have a minimum of 15 degrees of ankle range of motion as measure on the weight bearing lunge
Minimum age
4 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Children who toe walk from a neuromuscular medical condition
- Children with an ITW gait who have had treatment with the use of full length orthotics or serial casting within the past 12 month.
- Children who have a toe walking gait and have autism or global developmental delay
- Children who have had Botox as part of their treatment for ITW.

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)
All children presenting with a toe walking clinic of Monash Childrens (VPRS), diagnosed with idiopathic toe walking and meet the eligibility criteria, will be offered participation within the study. No allocation concealment will be employed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within subject randomised controlled trial with Latin square allocation for first 3 external stimuli conditions and a quasi-experimental 4th external stimuli condition conducted following completion of the first 3 external stimuli conditions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
4/03/2013
Date of last participant enrolment
Anticipated
Actual
25/03/2015
Date of last data collection
Anticipated
Actual
14/05/2015
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285974 0
Hospital
Name [1] 285974 0
Southern Health
Country [1] 285974 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Footwork Podiatric Laboratory
Address
(PO Box 5218)
No 2, 27 - 28 Carl Court
Hallam VIC 3803
Country
Australia
Secondary sponsor category [1] 284795 0
None
Name [1] 284795 0
Address [1] 284795 0
Country [1] 284795 0
Other collaborator category [1] 277064 0
University
Name [1] 277064 0
Monash University
Address [1] 277064 0
Clayton Campus
Wellington Road
Monash University,
Victoria 3800
Country [1] 277064 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288005 0
Southern Health
Ethics committee address [1] 288005 0
Research Directorate
Level 4, Main Block
Monash Medical Centre
Clayton Victoria 3168
Ethics committee country [1] 288005 0
Australia
Date submitted for ethics approval [1] 288005 0
Approval date [1] 288005 0
05/09/2012
Ethics approval number [1] 288005 0
Project No. 12102B

Summary
Brief summary
Frequently toe walking gait is most commonly the result of disease processes, trauma or neurogenic influences like Cerebral Palsy, Muscular Dystrophy or Autism Spectrum Disorders. Idiopathic toe walking (ITW) is by definition, the diagnosis of a tip toe gait adapted in the absence of a medical condition. Toe walking can be normal in children up until the age of 3. Persistent toe walking after 3 years of age should present to medical and allied health staff for comprehensive assessment. ITW is reported to be present in up to 12% of the population and has a strong hereditary link.

Long term ITW is associated with reduced ankle range of motion. Reported treatments often includes serial casting, Botox and in some cases tendoachilles surgical lengthening to improve this range of motion at the ankle. In the adolescent and adult, reduced ankle range of motion is associated with forefoot pain, heel pain and reduced quality of life.

Investigating the immediate impact of simple and non-invasive treatment options for children with ITW is important for future research and treating clinicians.

This pilot study investigates the acute impact of current footwear, footwear and orthotics and whole body vibration stimulation on ITW. The GAITRite ('Registered Trademark') system will be used to measure if any one intervention improves heel contact.
Trial website
Trial related presentations / publications
Williams, CM, Michalitsis, J., Murphy, A., Rawicki, B., Haines, T. Does external stimuli impact the gait of children with idiopathic toe walking: a study protocol for a within subject randomized control trial. BMJ Open, 2013, 3(3)
Public notes

Contacts
Principal investigator
Name 33910 0
Dr Cylie Williams
Address 33910 0
Monash Health
Allied Health research unit
Kingston & Warrigal Rds,
Cheltenham, VIC 3192
Country 33910 0
Australia
Phone 33910 0
+61398748125
Fax 33910 0
Email 33910 0
[email protected]
Contact person for public queries
Name 17157 0
Dr Cylie Williams
Address 17157 0
Allied Health Research Unit
Cnr Warrigal and Kingston Rds
Cheltenham VIC 3192
Country 17157 0
Australia
Phone 17157 0
+61398748125
Fax 17157 0
Email 17157 0
[email protected]
Contact person for scientific queries
Name 8085 0
Dr Cylie Williams
Address 8085 0
Allied Health Research Unit
Cnr Warrigal and Kingston Rds
Cheltenham VIC 3192
Country 8085 0
Australia
Phone 8085 0
+61398748125
Fax 8085 0
Email 8085 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
EmbaseWhole-Body Vibration Results in Short-Term Improvement in the Gait of Children with Idiopathic Toe Walking.2016https://dx.doi.org/10.1177/0883073816643405
EmbaseFull length foot orthoses have an immediate treatment effect and modify gait of children with idiopathic toe walking.2019https://dx.doi.org/10.1016/j.gaitpost.2018.11.022
N.B. These documents automatically identified may not have been verified by the study sponsor.