Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000330943
Ethics application status
Approved
Date submitted
25/02/2020
Date registered
10/03/2020
Date last updated
12/03/2020
Date data sharing statement initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can adding brain stimulation to strength training improve outcomes in adults with cerebral palsy?
Scientific title
Investigating the effects of strength training with and without transcranial direct current stimulation on strength and function in the upper limb of adults with spastic hemiplegic cerebral palsy
Secondary ID [1] 300645 0
Nil known
Universal Trial Number (UTN)
U1111-1248-7490
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 316427 0
Condition category
Condition code
Neurological 314687 314687 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strength training + Transcranial Direct Current Stimulation.
Participants will perform a 12-week one-on-one strength training intervention with a focus on the upper limbs, under the supervision of an Accredited Exercise Physiologist, with the assistance of a PhD candidate. Participants will be trained at Victoria University Clinical Exercise and Rehabilitation (VUCER) clinic. This program will operate for three days per week; thirty minutes per day. The training program will consist of 1) 5 min aerobic exercise with an arm cycle ergometer; 2) 20 min strength exercise at 70% of 1RM of the upper part of the body; and 3) 5 min of stretching.
Before each strength training session, 2 mA anodal tDCS over the primary motor cortex will be applied for 20 minutes. Anodal tDCS is a type of brain stimulation that involves placing electrodes over the head, which delivers low direct current through to the underlying brain. Anodal stimulation is positive, which means that the current will stimulate the part of the brain where the electrode is placed.
This study will be utilizing progressive resistance strength training, commonly used in people with CP. Participants will be asked to complete 2-3 sets of 12 repetitions maximum of each exercise (which correspond to an intensity of around 70% of 1RM), with at least 1 min between set. The weight will be increased by 5% at the successful completion of 2-3 set of 12 repetitions.
Intervention code [1] 316975 0
Treatment: Devices
Intervention code [2] 316976 0
Rehabilitation
Comparator / control treatment
The control group undertake the same strength training as above, but undergo "sham" tDCS. In this instance, the device is placed over the cortex in the same manner, but after 30 secs, the stimulation ceases. The cessation of the stimulation is not identifiable by the participant, thus leaving them blinded to their treatment group. The stimulator remains in place for 20 mins, as per the intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 323014 0
Change in strength, measured using an isokinetic dynamometer.
Timepoint [1] 323014 0
Baseline, 12 weeks after intervention commencement
Secondary outcome [1] 380529 0
Change in cerebral hemodynamic response of the primary motor cortex, measured using functional Near Infrared Spectroscopy.
Timepoint [1] 380529 0
Baseline, 12 weeks after commencement of intervention
Secondary outcome [2] 380530 0
Change in upper limb function (box and block text, nine hole peg test, Disabilities of arm, shoulder and hand questionnaire).
Timepoint [2] 380530 0
Baseline, 12 weeks after commencement of intervention.

Eligibility
Key inclusion criteria
Diagnosis of spastic hemiplegic cerebral palsy.
Intellectual capacity to understand and cooperate during the proposed activities.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Surgical procedures or neurolytic block in the 12 months prior to testing; Orthopedic deformity of the upper limb with an indication for surgery; Epilepsy; Pregnancy; Contraindication for tDCS as per screening questionnaire, and / or any acute medical disorder that would make strength training contraindicated, including active malignancy, severe heart, lung, renal, and liver failure.

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)
Allocation will be made by the Chief Investigator, who is not involved in the testing or intervention phases of the treatment. The latter will be carried out by an Accredited Exercise Physiologist, supported by a PhD candidate. These two members of the team will not be aware of participant allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Conducted using computer software (simple randomisation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous work suggested a ST study in CP could expect a effect size of d = 1.2. G*Power 3.1 was used to determine sample size, at 0.8 power, with an alpha of 0.05 To examine pre-post within-group effects, a minimum N of 6 is required and for between-group (sham vs. tDCS), a total N of 20 is required. As some drop-out is expected to occur during intervention, we aim to recruit a total of 24 individuals with SH-CP, allowing for two dropouts per group while maintaining power.

Results will be submitted to 2-way ANOVAs, where groups (sham vs tDCS) will be the independent variables and the following variables will be dependent variables: OxyHb, DeOxyHB, maximum isometric strength and maximum isokinetic strength, and peak RMS and MPF EMG. In addition, the results from the functional measures (the time taken to complete the Nine Hole Peg Test and the Box and Block Test and the % DASH score) pre-intervention will be compared to post-intervention data, also using 2-way ANOVAs with groups (sham vs tDCS) as the independent variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305069 0
University
Name [1] 305069 0
Victoria University
Country [1] 305069 0
Australia
Funding source category [2] 305070 0
Charities/Societies/Foundations
Name [2] 305070 0
Cerebral Palsy Alliance
Country [2] 305070 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
PO Box 1228
Melbourne, VIC, 8001
Country
Australia
Secondary sponsor category [1] 305447 0
None
Name [1] 305447 0
Address [1] 305447 0
Country [1] 305447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305459 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 305459 0
Ethics committee country [1] 305459 0
Australia
Date submitted for ethics approval [1] 305459 0
29/11/2019
Approval date [1] 305459 0
03/03/2020
Ethics approval number [1] 305459 0
HRE19-189

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

Contacts
Principal investigator
Name 100450 0
A/Prof Jacqueline Williams
Address 100450 0
Victoria University
Institute for Health and Sport
PO Box 14428
Melbourne VIC 8001
Country 100450 0
Australia
Phone 100450 0
+61 399194025
Fax 100450 0
Email 100450 0
[email protected]
Contact person for public queries
Name 100451 0
Jacqueline Williams
Address 100451 0
Victoria University
Institute for Health and Sport
PO Box 14428
Melbourne VIC 8001
Country 100451 0
Australia
Phone 100451 0
+61 399194025
Fax 100451 0
Email 100451 0
[email protected]
Contact person for scientific queries
Name 100452 0
Jacqueline Williams
Address 100452 0
Victoria University
Institute for Health and Sport
PO Box 14428
Melbourne VIC 8001
Country 100452 0
Australia
Phone 100452 0
+61 399194025
Fax 100452 0
Email 100452 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
We do not have ethics approval to share data.


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.