ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

NIL

Universal Trial Number (UTN)

NIL

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Congenital Talipes Equino Varus

Condition category

Condition code

Musculoskeletal

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]

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]

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Angela Shearwood

Address [1]

University of Melbourne
School of Physiotherapy(postgraduate student)
Level 2
200 Berkeley Street
Carlton 3000 VIC

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Melbourne

Address [2]

As part completion towards the Doctor of Clinical Physiotherapy.

Country [2]

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]

Hospital

Name [1]

Princess Margaret Hospital, Perth

Address [1]

Roberts Road, Subiaco WA 6008
Postal Address: PO Box D184, Perth WA 6840

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Princess Margaret Hospital

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

02/08/2011

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Angela Shearwood

Address

University of Melbourne
School of Physiotherapy(post graduate student)
Level 2
200 Berkeley Street
Carlton 3000 VIC

Country

Australia

Phone

061 0432285051

Fax

a.shearwood@postgrad.unimelb.edu.au

Contact person for scientific queries

Name

Angela Shearwood

Address

University of Melbourne
School of Physiotherapy(post graduate student)
Level 2
200 Berkeley Street
Carlton 3000 VIC

Country

Australia

Phone

061 0432285051

Fax

a.shearwood@pgrad.unimelb.edu.au

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.

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