Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000120976
Ethics application status
Approved
Date submitted
28/01/2011
Date registered
2/02/2011
Date last updated
6/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of myofascial trigger point therapy to stretching and strengthening for maintaining or increasing muscle length in muscles with spasticity.
Scientific title
The application of Myofascial Trigger Point therapy in maintaining or increasing muscle length in muscles with spasticity, influencing the need for Botox and functional ability in School Aged Children with Spastic Cerebral Palsy (GMFCS level I-III).
Secondary ID [1] 253497 0
None
Universal Trial Number (UTN)
U1111-1119-2475
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spastic Cerebral Palsy 261045 0
Condition category
Condition code
Neurological 259187 259187 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 259198 259198 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research project will be divided into the application of two therapy blocks of 12 weeks, allowing the study to be a cross-over study. Participants will not have a break between blocks. One block will consist of stretching, strengthening and massage. The other block will consist of stretching, strengthening, massage and the application of myofascial trigger point therapy. Myofascial trigger points will be applied once a week by a qualified Physiotherapist and daily by the parents/carer for approximately 15minutes. Stretching, strengthening and massage will be carried out daily for a further 15 minutes. Measurements will be taken pre and post each block and will include, muscle length, quality of life survey, functional tests (ie hopping, single leg stand and heel-toe walk) and the need for botox. A follow up assessment will also be carried out 6 weeks later.
Intervention code [1] 257932 0
Rehabilitation
Comparator / control treatment
The control treatment will consist of a routine therapy block - stretching, strengthening and soft tissue massage. Each participant will undergo this control treatment for 12 weeks either prior or after the application of myofascial trigger points.
Control group
Active

Outcomes
Primary outcome [1] 262037 0
The need for botox application. This will be measured by the consulting physician who regularly measures muscle length and function and decides upon the need for this form of treatment. The measure of this outcome will be based on the incidence for botox prescription.
Timepoint [1] 262037 0
Post each block of treatment
Primary outcome [2] 262038 0
Muscle length of gastroc and soleus. These measurements will be based on goniometer measurements taken by a blinded therapist pre and post each block of treatment. Photos will also be taken of standing muscle length pre and post each block of treatment.
Timepoint [2] 262038 0
Pre and Post each block of treatment
Secondary outcome [1] 273016 0
Quality of life surveys will be taken pre and post each block of treatment. These will be completed by the parent/carer.
Timepoint [1] 273016 0
Pre and post each block of treatment
Secondary outcome [2] 273017 0
Functional tests using part of the Movement ABC. Tests will include hopping, single leg stand and heel-toe walking.
Timepoint [2] 273017 0
Pre and Post each block of treatment

Eligibility
Key inclusion criteria
Children aged between 5 and 12 years
Cerebral Palsy GMFCS level I and III with muscle spasticity
Parent and Doctor consent
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None required.

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)
We can identify potential participants from the pool of clients at Therapy ACT and approach them to consider participation in the project at the end of their therapy sessions. If they are interested we will send a letter describing the project and invite them to apply. Most of the screening can be done before approaching the clients. Those that respond will then be considered for the project. Following this, names of all potential candidates will be placed in bag and 20 names will be pulled out for participation. Following selection of the 20 candidates, participants will be randomized into groups using permuted block randomization from a computer random number generator, with the randomization result sealed in an envelope. Once a participant has arrived for the pre assessment the envelope will be opened to determine which group they are selected into.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To divide the 20 participants into 2 groups will use a permuted block randomization on a computer to generate a number. This will be sealed in an envelope and the envelope opened at the participants pre-assessment.
Masking / blinding
Blinded (masking 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
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258399 0
Self funded/Unfunded
Name [1] 258399 0
Country [1] 258399 0
Primary sponsor type
Government body
Name
Therapy ACT
Address
Cnr Weingarth and Blackwood Terrace Holder 2611 ACT
Country
Australia
Secondary sponsor category [1] 257547 0
None
Name [1] 257547 0
Address [1] 257547 0
Country [1] 257547 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260374 0
NEAF
Ethics committee address [1] 260374 0
Ethics committee country [1] 260374 0
Australia
Date submitted for ethics approval [1] 260374 0
05/02/2011
Approval date [1] 260374 0
20/07/2011
Ethics approval number [1] 260374 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32143 0
Address 32143 0
Country 32143 0
Phone 32143 0
Fax 32143 0
Email 32143 0
Contact person for public queries
Name 15390 0
Michelle Elmitt
Address 15390 0
Cnr of Weingarth and Blackwood Terrace Holder 2611 ACT
Country 15390 0
Australia
Phone 15390 0
+61 2 6105 1275
Fax 15390 0
Email 15390 0
[email protected]
Contact person for scientific queries
Name 6318 0
Michelle Elmitt
Address 6318 0
Cnr of Weingarth and Blackwood Terrace Holder 2611 ACT
Country 6318 0
Australia
Phone 6318 0
+ 61 2 6205 1275
Fax 6318 0
Email 6318 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.