Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002027291
Ethics application status
Approved
Date submitted
10/12/2018
Date registered
18/12/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Vibration therapy for cerebral palsy toddlers
Scientific title
Explore the feasibility of using vibration therapy in children 2-4 years at high risk of neuromuscular disability. A pilot study.
Secondary ID [1] 296638 0
Nil known
Universal Trial Number (UTN)
U1111-1224-1500
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy
 310465 0
Condition category
Condition code
Neurological 309177 309177 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Control period. Before the intervention period, each participant will undergo 12 weeks of the control period. During the control period, participants will continue their usual activity levels and standard care.
Intervention period (12 weeks). Vibration therapy (VT) will be performed using the Galileo Basic vibration plates (Novotec Medical, Pforzheim, Germany). Each session will last 18 min: 3 min vibration followed by 3 minutes rest- repeated 3 times. Sessions will be performed 4 times a week, over 12- week period. Participants will start with sessions of three 1-minute bouts at 12 Hz, and both intensity and duration will be gradually increased according to the response of each individual. By the end of week 4, all participants should be training at the prescribed protocol of 3 sets of 3 minutes at intensity 20Hz. Training intensity will be maintained at 20Hz for the remainder of the intervention.
Participants will stand barefoot on the plate with the knee slightly bent. An adjustable metal frame will be used for participants with poor balance for safely. Parents also will be trained to support children during the training sessions. Training sessions will be performed at home. An experienced exercise physiologist from the research team will supervise the participants performing training at home once a week in order to monitor progress and provide feedback/support. Parents/caregivers will provide ongoing supervision of home sessions.
Intervention code [1] 312946 0
Treatment: Devices
Comparator / control treatment
12 week control period is a comparator to assess the effects of vibration therapy.
During the control period, participants will continue their usual activity levels and standard care with no vibration therapy.
Control group
Active

Outcomes
Primary outcome [1] 308150 0
Gross motor function assessed by Gross motor function measure (GMFM) - 66
Timepoint [1] 308150 0
T0 - baseline, T1 - 12 weeks after the control period (control), T2 – after completing 12 weeks of vibration therapy.
Secondary outcome [1] 354086 0
Body composition assessed by Dual Energy X-Ray Absorptiometry (DEXA scan)
Timepoint [1] 354086 0
T0 - baseline, T1 - 12 weeks after the control period (control), T2 – after completing 12 weeks of vibration therapy.
Secondary outcome [2] 354087 0
Muscle function assessed by jump power using the Leonardo mechanography force plate
Timepoint [2] 354087 0
T0 - baseline, T1 - 12 weeks after the control period (control), T2 – after completing 12 weeks of vibration therapy.
Secondary outcome [3] 354088 0
Balance assessed by using the Leonardo mechanography force plate
Timepoint [3] 354088 0
T0 - baseline, T1 - 12 weeks after the control period (control), T2 – after completing 12 weeks of vibration therapy
Secondary outcome [4] 354090 0
Physical Activity assessed by using Physical Activity Monitor (ActivPal).
Timepoint [4] 354090 0
T0 - baseline, T1 - 12 weeks after the control period (control), T2 – after completing 12 weeks of vibration therapy
Secondary outcome [5] 354091 0
Quality of life questionnaire assessed by Pediatric Quality of Life Inventory Cerebral Palsy Module. (Peds QL CP)
Timepoint [5] 354091 0
T0 - baseline, T1 - 12 weeks after the control period (control), T2 – after completing 12 weeks of vibration therapy
Secondary outcome [6] 354092 0
Physical function assessed using 10 meters walk/run test
Timepoint [6] 354092 0
T0 - baseline, T1 - 12 weeks after the control period (control), T2 – after completing 12 weeks of vibration therapy

Eligibility
Key inclusion criteria
- Have diagnosed cerebral palsy or indication of having cerebral palsy as per neurologist report GMFCS I – III
- Be able to safely stand on the vibration platform
- Be able to understand researcher’s instructions and follow them
Minimum age
2 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A bone fracture within 12 weeks of enrolment
- Acute thrombosis, tendinitis, nephrolithiasis, discopathy or arthritis
- History of clinically significant organic disease or findings on physical examination, which in the opinion of the Investigator would prevent the patient from completing the study.
- History of using any of the following medications, regardless of dose, for at least 1 month, within 3 months of enrolment: anabolic agents, glucocorticoids (does not include inhaled glucocorticoids) or growth hormone.
- History of botulinum toxin injection into lower limbs within 3 months of enrolment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study is a pilot clinical experiment where all participants act as their own control with all participants having a lead-in period for 12 weeks, followed by the intervention of 12 weeks of the vibration therapy.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/05/2019
Actual
2/09/2019
Date of last participant enrolment
Anticipated
Actual
7/11/2020
Date of last data collection
Anticipated
Actual
24/04/2021
Sample size
Target
20
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 21045 0
New Zealand
State/province [1] 21045 0

Funding & Sponsors
Funding source category [1] 301216 0
University
Name [1] 301216 0
University of Auckland, Liggins Institute
Country [1] 301216 0
New Zealand
Primary sponsor type
Individual
Name
Prof Paul Hofman
Address
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 300850 0
None
Name [1] 300850 0
Address [1] 300850 0
Country [1] 300850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301961 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 301961 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 301961 0
New Zealand
Date submitted for ethics approval [1] 301961 0
10/01/2019
Approval date [1] 301961 0
16/04/2019
Ethics approval number [1] 301961 0

Summary
Brief summary
Cerebral palsy (CP) is the most common disability in childhood. CP is characterized by impaired mobility, low muscle mass, low bone density, and increased muscle tone. Therefore, one of the major focus of therapy in children with CP lies in increasing muscle mass, decreasing spasticity and, consequently, improving mobility, weight bearing and bone health. Despite the fact that children with CP have a number of therapeutic and surgical options to improve health and motor function, there is a void in interventions with a comprehensive effect on mobility, muscle mass and function, and bone strength. Vibration therapy (VT) has the potential to fill this therapeutic void. A recent extensive study on adolescents has shown a positive effect of vibration therapy on mobility, balance,
and bone and muscle health in this age group. We anticipate that children between 2 and 4 years old will benefit even more, as these children are rapidly growing and developing. However, there have been no extensive studies on this age group with a rigorous research design and assessment. This study will address this issue, by assessing the feasibility of implementing VT as an early intervention on children with cerebral palsy as early as 2
years old.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88682 0
Prof Paul Hofman
Address 88682 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 88682 0
New Zealand
Phone 88682 0
+64 09 923 6453
Fax 88682 0
Email 88682 0
[email protected]
Contact person for public queries
Name 88683 0
Mrs Alena Adaikina
Address 88683 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 88683 0
New Zealand
Phone 88683 0
+64 09 236098
Fax 88683 0
Email 88683 0
[email protected]
Contact person for scientific queries
Name 88684 0
Mrs Alena Adaikina
Address 88684 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 88684 0
New Zealand
Phone 88684 0
+64 09 236098
Fax 88684 0
Email 88684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.