Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000454572
Ethics application status
Not yet submitted
Date submitted
19/10/2006
Date registered
24/10/2006
Date last updated
24/10/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of multimedia to improve home based exercise performance and adherence in children.
Scientific title
Comparing the use of a multimedia module to routine clinical practice in improving performance and adherence to home based exercise in children requiring stretching exercise in their physiotherapy program.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients requiring standing gastrocnemius stretching exercise or standing quadriceps stretching exercise as part of their physiotherapy program at home for any condition 1428 0
Condition category
Condition code
Physical Medicine / Rehabilitation 1524 1524 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm will receive

· Standard exercise instruction includes a discussion of basic anatomy and verbal explanation of the exercise
· Demonstration of the exercise by the physiotherapist
· Physiotherapist give verbal feedback and correction of technique
· Child and parent view the multimedia package (CD containing animation of the exercises) with physiotherapist.
· The child will be expected to perform the exercise twice a day at home (This amount was decided by the physiotherapists involve in this study. It is based upon the usual amount they prescribe to children requiring this exercise).
· Exercise diary will be provided to be taken home and filled out by the children for the next four weeks.


Patient will be asked to come for review in 4 weeks time. At the review appointment, the child will be asked to hand in the diary and perform the exercise whilst it is recorded by 2 video cameras.
Intervention code [1] 1412 0
Other interventions
Comparator / control treatment
Control Arm- Current clinical practice adopted by the physiotherapist in RCH

· Standard exercise instruction includes a discussion of basic anatomy and verbal explanation of the exercise
· Demonstration of the exercise by the physiotherapist
· Physiotherapist give verbal feedback and correction of technique
· Read the instructional leaflet
· The child will be expected to perform the exercise twice a day at home (This amount was decided by the physiotherapists involve in this study. It is based upon the usual amount they prescribe to children requiring this exercise).
· Exercise diary will be provided to be taken home and filled out by the children for the next four weeks.
Control group
Active

Outcomes
Primary outcome [1] 2106 0
Accuracy of the exercise technique.
Timepoint [1] 2106 0
Measured 4 weeks from the first visit (at the start of the intervention). It will be measured using the participant's exercise video that will be taped during their second visit. The exercise video will be assessed by blinded independant expert panel.
Secondary outcome [1] 3648 0
Adherence to exercise program.
Timepoint [1] 3648 0
This will be measured 4 weeks from the first visit (at the start of the intervention).It will be measured using data from participant's exercise diary.

Eligibility
Key inclusion criteria
Require stretching exercise (standing gastrocnemius stretch or standing quadriceps stretch) at home•Have access to multimedia player at home
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cognitive impairment•Patient with visual impairment. •Patient with hearing impairment. •Patients who require more than 3 type of exercise as part of their home exercise regimen. •Non-English speaking.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who are off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor of the study will be blinded.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1662 0
University
Name [1] 1662 0
Advance Medical Science Student Fund (University of Melbourne – Part of Medical Degree Program)
Country [1] 1662 0
Australia
Funding source category [2] 1663 0
Hospital
Name [2] 1663 0
Limb Reconstruction Funding (Royal Children's Hospital)
Country [2] 1663 0
Australia
Primary sponsor type
Individual
Name
Mr. Leo Donnan
Address
Country
Secondary sponsor category [1] 1467 0
None
Name [1] 1467 0
N/A
Address [1] 1467 0
Country [1] 1467 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
This study seeks to evaluate whether a multimedia approach improves performance and adherence of children to a home based exercise program prescribed by physiotherapist. This study will compare the usual current practice of providing verbal instructions and information leaflet to the new approach of providing a multimedia package in addition to verbal instructions.The hypotheses of this study is that a multimedia approach will improve the child’s motivation to perform exercises and therefore increase their adherence to the prescribed program. We also hypothesised that providing an audio-visual reference for children will aid learning and increase their technical proficiency in performing the exercises. This trial will involve patients ranging between 6-18 years recruited from orthopaedic outpatient’s clinic (RCH), who require stretching exercises for either their calf or thigh muscles as part of their treatment. Patients will be divided randomly into two groups. Each group will receive either an instructional leaflet or a multimedia CD containing the exercise program to be taken home. They will also receive a diary to record their adherence to exercise. Patients will be asked to return to the clinic 4 weeks after the initial consultation, and their exercise technique will be recorded on video and later evaluated by blinded expert panel.This information will then be analysed to see whether there is any improvement in the frequency (adherence) and the quality (performance) of the exercises.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27346 0
Address 27346 0
Country 27346 0
Phone 27346 0
Fax 27346 0
Email 27346 0
Contact person for public queries
Name 10601 0
Mr. Leo Donnan
Address 10601 0
Orthopaedic Surgery
Royal Children’s Hospital
Level 3 Main Building
Flemington Road
Parkville VIC 3052
Country 10601 0
Australia
Phone 10601 0
+61 3 93455450
Fax 10601 0
Email 10601 0
[email protected]
Contact person for scientific queries
Name 1529 0
Ms. Farah Albi Abdul Patah
Address 1529 0
Orthopaedic Surgery
Royal Children’s Hospital
Level 3 Main Building
Flemington Road
Parkville VIC 3052
Country 1529 0
Australia
Phone 1529 0
+61 3 93455450
Fax 1529 0
Email 1529 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.