Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000736943
Ethics application status
Not yet submitted
Date submitted
16/06/2011
Date registered
14/07/2011
Date last updated
14/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional Motor Skills In Children with treated Congenital Talipes Equino Varus (CTEV)(clubfoot)
Scientific title
A comparison of functional motor skills in children aged five to seven years with non-operatively treated CTEV versus age and gender matched controls
Secondary ID [1] 262392 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Talipes Equino Varus 268095 0
Condition category
Condition code
Musculoskeletal 268238 268238 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study. Children with traeted CTEV will be observed one time post treatment cessation between the age of 5 to 6 years.
Intervention code [1] 266778 0
Not applicable
Comparator / control treatment
The functional motor skills in children with treated CTEV will be compared to a n age and gender matched control group.(children born without CTEV).
Additionally a correlation will be sought between clinical outcomes achieved (foot shape, muscle strength etc) and functional motor skills.
Control group
Active

Outcomes
Primary outcome [1] 268971 0
Functional Motor Skills in children with treated CTEV. Children will be assessed using the Movement Assessment for Children (MABC) and the Clubfoot Assessment Protocol(CAP).
Timepoint [1] 268971 0
Completion of treatment
Children between the age of 5 and 6 because this is when children commence school and more formal sporting activities and begin to show more mature functional movement skills. children will be assessed once only in each participant.
Secondary outcome [1] 276729 0
Correlation between clinical outcomes (foot shape, flexibility, presence of pain) and functional motor skills ability to jump hop, kick a ball, skip etc. Children with treated clubfeet will have their clinical outcome be assessed using the CAP. The children with treated clubfeet will have their functional motor skills will be assessed using the MABC. A correlation will be sought between clinical outcomes and functional motor outcomes.
Both groups (treated clubfeet and controls) will have their functional motor skills assessed with the MABC and the two groups compared.
Timepoint [1] 276729 0
Children between the age of 5 and 6 because this is when children commence school and more formal sporting activities and begin to show more mature functional movement skills. This will occur on a single occasion only.
Secondary outcome [2] 276730 0
Correlation between clinical outcomes (foot shape, flexibility, presence of pain), functional motor skills ability to jump hop, kick a ball, skip etc and parent reported quality of life. A Quality of Life Questionaire (condition specific) will be administered.
Timepoint [2] 276730 0
Children between the age of 5 and 6 because this is when children commence school and more formal sporting activities and begin to show more mature functional movement skills. This will be assessed on a single occasion only.

Eligibility
Key inclusion criteria
Children with CTEV who have undergone treatment using a nonoperative method of correction , who have completed treatment and who are aged between 5 and 6 years.
Minimum age
5 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children whose CTEV is related to some other syndrome. e.g. spina bifida, sacral agenesis, arthrogryposis.

Children who have a history of difficult delivery, prematurity, developmental delay or low tone.

Children who have a co-existing medical diagnosis known to affect motor abilities i.e. Developmental
Coordination Dysfunction (DCD), Attention Hyperactivity Deficit disorder (ADHD), autism, or other diagnosed syndromes.

Children not able to cooperate with the testing, for any reason.

Children who within the course of treatment were considered to have had a relapse/recurrence necessitating additional treatment or surgical intervention above what the method describes. (Currently while considered primarily non-operative, the vast majority of children undergoing treatment method do undergo a percutaneous elongation of the tendo-achilles (ETA) .

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267256 0
Self funded/Unfunded
Name [1] 267256 0
Angela Shearwood
Country [1] 267256 0
Australia
Funding source category [2] 267431 0
University
Name [2] 267431 0
University of Melbourne
Country [2] 267431 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
School of Physiotherapy (postgraduate student)
Level 2
200 Berkeley Street
Carlton 3000 VIC
Country
Australia
Secondary sponsor category [1] 266320 0
Hospital
Name [1] 266320 0
Princess Margaret Hospital, Perth
Address [1] 266320 0
Roberts Road, Subiaco WA 6008
Postal Address: PO Box D184, Perth WA 6840
Country [1] 266320 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269245 0
Princess Margaret Hospital
Ethics committee address [1] 269245 0
To be submitted to PMH ethics committee August 2011
Roberts Road, Subiaco WA 6008
Postal Address: PO Box D184, Perth WA 6840
Ethics committee country [1] 269245 0
Australia
Date submitted for ethics approval [1] 269245 0
02/08/2011
Approval date [1] 269245 0
Ethics approval number [1] 269245 0

Summary
Brief summary
Clubfoot/feet is a common foot deformity seen in newborn infants. While it can occur along side other conditions, most babies with clubfoot are otherwise healthy. Clubfoot affects about one baby in every 1,000 born. Fifty percent of babies with clubfoot are affected in both feet, and males are affected slightly more often than females. The cause is unknown.

Treatment for clubfoot aims to correct the deformity that is help the baby’s foot rest flat on the ground and be flexible and pain-free. After correction, bracing and splinting are important in preventing the baby’s foot from reverting back to the curved position. The treatment in total takes can take between 2-4 years. The treatment of the clubfoot deformity is very successful.

What is less well understood in children with treated clubfoot/feet is their later ability to perform activities such as running, jumping, kicking a ball and participating in sports i.e. once the deformity corrected i.e the foot now straight- is the child able to do all the typical things a child of a similar age can do?

The aim of this study is to look at the functional motor skills (i.e. the way a child can run, move, kick a ball) in children treated for clubfeet compared to children of the same age who were not born with clubfeet. Further, this study hopes to see if there is a relationship between the shape, flexibility and strength of the treated foot and the child’s later motor abilities. Also it hopes to examine how the child’s parents perceive their child’s quality of life related to their treated clubfoot using a quality of life questionnaire specific for clubfeet.

Fifteen children who have completed treatment for clubfeet and 15 children without clubfeet will be assessed using a test that identifies and describes children with motor difficulties. The motor abilities of the two groups will be compared. The children with treated clubfeet will have 2 further assessments done. The first assessment looks at the child’s foot shape, flexibility and strength of the foot and the child’s ability to perform simple activities such as hopping, standing on one leg etc. In the second assessment, parents of children with treated clubfeet will also be asked to fill out a questionnaire on how they rate their child’s quality of life. Rating of quality of life will be compared to their score on foot shape, flexibility, muscle strength and motor abilities.

All assessments will be completed within a one hour session with assessments conducted by an experienced paediatric physiotherapist.

Children aged between five and six years have been chosen, as by this age, treatment is complete. The children are old enough to be able to cooperate in testing and also because at this age difficulties with motor abilities will be becoming more obvious as demands on the child’s motor abilities increase i.e. being able to run and keep up with playmates at school and the beginning of sporting and physical activities at school in a more structured way.

There are no identified ethical concerns. No assessment causes pain or discomfort and the assessment in total only takes 1 hour. No interventions are involved
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32750 0
Address 32750 0
Country 32750 0
Phone 32750 0
Fax 32750 0
Email 32750 0
Contact person for public queries
Name 15997 0
Angela Shearwood
Address 15997 0
University of Melbourne
School of Physiotherapy(post graduate student)
Level 2
200 Berkeley Street
Carlton 3000 VIC
Country 15997 0
Australia
Phone 15997 0
061 0432285051
Fax 15997 0
Email 15997 0
[email protected]
Contact person for scientific queries
Name 6925 0
Angela Shearwood
Address 6925 0
University of Melbourne
School of Physiotherapy(post graduate student)
Level 2
200 Berkeley Street
Carlton 3000 VIC
Country 6925 0
Australia
Phone 6925 0
061 0432285051
Fax 6925 0
Email 6925 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.