ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000010291

Ethics application status

Approved

Date submitted

16/12/2008

Date registered

7/01/2009

Date last updated

4/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

An internet program to improve physical activity in teenagers with cerebral palsy – Are you kidding??

Scientific title

A randomized controlled trial to test an internet-based program aimed at improving
physical activity behaviours in adolescents with cerebral palsy

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

cerebral palsy

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention group members used of a physical activity self-management program delivered via the internet. The intervention program was branded "Get Set" and was developed as an eight module, highly interactive internet program based upon social cognitive theory, incorporating education, quizzes, goal-setting, self-reflection and positive role-modelling. Modules were released weekly onto the Get Set website. Intervention group participants received a one-on-one introduction to the Get Set website prior to commencement of the program, and were encouraged to log in at least weekly for the program’s eight week duration.

Intervention code [1]

Behaviour

Comparator / control treatment

Control group participants were encouraged to continue their normal activities. At the end of the 20 week randomised controlled trial, control participants were offered the opportunity to undertake the intervention.

Control group

Active

Outcomes

Primary outcome [1]

physical activity behaviour (pedometer step counts)

Timepoint [1]

baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Secondary outcome [1]

exercise knowledge was assessed using a ten-item multiple choice questionnaire which was purpose developed for the study

Timepoint [1]

baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Secondary outcome [2]

self-reported exercise self-efficacy was assessed using the 8-item LEAP II exercise self-efficacy scale

Timepoint [2]

baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Secondary outcome [3]

self-reported exercise attitude was assessed using the 8-item LEAP II exercise attitude scale

Timepoint [3]

baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Secondary outcome [4]

self-reported exercise intention was assessed using the 4-item LEAP II exercise intention scale

Timepoint [4]

baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Secondary outcome [5]

functional capacity was measured using the six minute walk test. The six minute walk test is a simple, sub-maximal, clinical exercise test, in which the distance walked under controlled conditions in six minutes is measured.

Timepoint [5]

baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Secondary outcome [6]

self-reported physical activity behaviour was measured using the Multimedia Activity Recall for Children and Adolescents (MARCA). This is a computer-based, self-report tool that records young people's use of time in a 24 hour period. It was administered by phone interviews.

Timepoint [6]

baseline, immediately post-intervention (10 weeks post-baseline) and 10 weeks post-intervention (20 weeks post-baseline)

Eligibility

Key inclusion criteria

ambulant cerebral palsy

Minimum age

11 Years

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

attending a special school (special schools are government schools that cater for children with intellectual disability, including those with concurring physical disability. They are segregated from mainstream schools.).

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 were recruited via Novita Children’s Services, the sole provider of community-based therapy, equipment, and support services to children with physical disabilities in South Australia. They were sent a letter describing the study and inviting them to participate. Once eligibility and participation in the study was confirmed, participants were matched for Gross Motor Function Classification System (GMFCS) level (the single most important determinant of physical activity level in this population) and randomly assigned to intervention or control groups. Allocation was concealed, since recruitment of the entire cohort of participants was completed prior to any subjects being allocated to groups.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Each participant's name was recorded on a card and these were then sorted into three gross motor function categories (based on the severity of their cerebral palsy). Cards from each category were then placed face down and shuffled. Two names were drawn at a time to create random pairs of participants from the same gross motor function category. A coin toss was then used to randomly assign one person from each pair into the intervention group (internet-program), with the remaining person going into the control group (usual care). This process was completed for each gross motor function category. Where
there was an odd number of participants in a gross motor function category, a coin toss determined the group allocation of the lone participant.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

41

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cerebral Palsy Foundation of Australia

Address [1]

The Spastic Centre
321 Mona Vale Rd, Terrey Hills, NSW 2084

Country [1]

Australia

Primary sponsor type

University

Name

University of South Australia

Address

Street address:
City East Campus
North Terrace (no street number)
Adelaide, SA 5000
Postal address:
GPO Box 2471
Adelaide 5001 SA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee (UniSAHREC)

Ethics committee address [1]

Vicki Allen
Chair UniSAHREC
Research and Innovation Services 
GP2-09
Mawson Lakes Campus
University of South Australia
GPO Box 2471
Adelaide, SA 5001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2006

Approval date [1]

23/11/2006

Ethics approval number [1]

P248/06

Summary

Brief summary

Aim: To determine whether an online interactive intervention can improve physical activity and related behaviors in adolescents with cerebral palsy. 
Methods: Adolescents (11-17 year old) with cerebral palsy were recruited to this randomised controlled trial. Intervention participants used an 8-week online physical activity self-management program which incorporated education, self-reflection, goal setting and positive role modelling. Blinded assessments were undertaken at baseline, 10 weeks and 20 weeks. Outcomes included exercise knowledge, attitudes, intention and self-efficacy scales; self-reported physical and sedentary activity; objective physical activity; and functional capacity. 
Results: 41 adolescents (mean age 13y 7m: Standard Deviation 1y 8m; males n=26) participated. At the 10-week follow-up, the intervention group showed favourable changes (relative to the control group) approaching statistical significance for exercise knowledge (effect size 0.56, p=0.08) and physical activity behaviour as measured by pedometer (weekly step counts effect size 0.56, p=0.06; weekly moderate-to-vigorous physical activity effect size 0.50, p=0.06; weekly distance effect size 0.96, p=0.05). At the 20-week follow-up similar trends for change were observed but the effect sizes had weakened, suggesting a washout effect. 
Interpretation: Given the encouraging trends for change, interactive online programs may offer an effective alternative for participants unable to attend face-to-face programs.

Trial website

Trial related presentations / publications

Maher, CA, Williams, MT & Olds, TS 2008, „The six-minute walk test for children with cerebral palsy?, International Journal of Rehabilitation Research, vol 31, pp. 185-188.
Maher, C, Williams, M, Olds, T & Lane, A 2007, „Using the internet to increase physical activity in teenagers with cerebral palsy – are you kidding?! Part 1 – Program usability testing?, in Proceedings of the Sixth National Physical Activity Conference, Adelaide, Australia, 13-16 October. Maher, C, Williams, M, Olds, T & Lane, A 2007, „Using the internet to increase physical activity in teenagers with cerebral palsy – are you kidding?! Part 2 – Randomised controlled trial?, in Proceedings of the Sixth National Physical Activity Conference, Adelaide, Australia, 13-16 October.
Maher, C, Williams, M, Olds, T & Lane, A 2008, „Can an internet self-management program increase physical activity in teenagers with cerebral palsy? – a randomised controlled trial?, in Proceedings of the Australasian Academy of Cerebral Palsy and Developmental Medicine Biennial Conference, Adelaide, Australia, 10-12 March.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Carol Maher

Address

Centre for Applied Anthropometry
C7-42
City East Campus
University of South Australia
GPO Box 2471
Adelaide, SA 5001

Country

Australia

Phone

+6 8 8302 1741

Fax

Email

carol.maher@unisa.edu.au

Contact person for scientific queries

Name

Carol Maher

Address

Centre for Applied Anthropometry
C7-42
City East Campus
University of South Australia
GPO Box 2471
Adelaide, SA 5001

Country

Australia

Phone

+6 8 8302 1741

Fax

Email

carol.maher@unisa.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.