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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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)
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

Study type
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
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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 305069 0
Name [1] 305069 0
Victoria University
Address [1] 305069 0
PO Box 1228
Melbourne, VIC, 8001
Country [1] 305069 0
Funding source category [2] 305070 0
Name [2] 305070 0
Cerebral Palsy Alliance
Address [2] 305070 0
PO Box 6427
Frenchs Forest
NSW 2086
Country [2] 305070 0
Primary sponsor type
Victoria University
PO Box 1228
Melbourne, VIC, 8001
Secondary sponsor category [1] 305447 0
Name [1] 305447 0
Address [1] 305447 0
Country [1] 305447 0

Ethics approval
Ethics application status
Ethics committee name [1] 305459 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 305459 0
PO Box 14428
Melbourne Victoria 8001
Ethics committee country [1] 305459 0
Date submitted for ethics approval [1] 305459 0
Approval date [1] 305459 0
Ethics approval number [1] 305459 0

Brief summary
Individuals with spastic hemiplegic cerebral palsy (SH-CP) face a decrease in functional ability between 10 and 35 years of age, limiting health and quality of life. Interventions that reduce this decline are critical. Though loss of strength has been linked to functional decline in SH-CP, strength training (ST) programs have proven ineffective in improving neuromuscular function and are limited by relatively small strength gains. Strength gains may be slower in SH-CP as a result of alterations in the balance between excitation and inhibition in the primary motor cortex of the brain.

The research proposed here will explore this issue using functional near-infrared spectroscopy (fNIRS) to measure brain activity during strength tasks, and to evaluate possible adaptions due to strength training. It will determine the impact of anodal transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, on the observed pattern of neural activity and subsequently, determine whether anodal tDCS, prior to ST, leads to faster and larger strength gains in CP. This research has the potential to improve ST outcomes in SH-CP and lead to increased understanding of the adaptions of the brain in response to anodal tDCS and exercise in SH-CP.
Trial website
Trial related presentations / publications
Public notes

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
Phone 100450 0
+61 399194025
Fax 100450 0
Email 100450 0
Contact person for public queries
Name 100451 0
A/Prof Jacqueline Williams
Address 100451 0
Victoria University
Institute for Health and Sport
PO Box 14428
Melbourne VIC 8001
Country 100451 0
Phone 100451 0
+61 399194025
Fax 100451 0
Email 100451 0
Contact person for scientific queries
Name 100452 0
A/Prof Jacqueline Williams
Address 100452 0
Victoria University
Institute for Health and Sport
PO Box 14428
Melbourne VIC 8001
Country 100452 0
Phone 100452 0
+61 399194025
Fax 100452 0
Email 100452 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
We do not have ethics approval to share data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results