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Trial registered on ANZCTR


Registration number
ACTRN12616000594426
Ethics application status
Approved
Date submitted
5/05/2016
Date registered
9/05/2016
Date last updated
9/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The CONEXT study: COmbining EXergaming with Transcranial direct current stimulation to improve balance in people with Parkinson’s disease.
Scientific title
The CONEXT study: Exploring the effects of CONcurrent Exergaming and Transcranial direct current stimulation on balance, cognitive function and corticospinal excitability in people with idiopathic Parkinson's disease.
Secondary ID [1] 289134 0
None
Universal Trial Number (UTN)
U1111-1182-5698
Trial acronym
CONEXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance Dysfunction/Postural Instability 298635 0
Cognitive Decline 298636 0
Parkinson's disease 298676 0
Condition category
Condition code
Neurological 298701 298701 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 298730 298730 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to investigate the effects of combining virtual reality (VR) exercise gaming (exergaming) with a non-invasive brain stimulation technique (transcranial direct current stimulation [tDCS]) to improve the balance, cognition and brain function of people with Parkinson's disease (PD). There is a 6 month research trial that includes 3 months of exergaming with a follow-up testing session conducted a further 3 months after completion of the trial. All participants will be randomly allocated to one of three groups, with two exergaming groups receiving either real or sham tDCS, and one standard care group. Each exergaming session will last for approximately 40 mins, and will be conducted one-on-one with an experienced clinical exercise therapist at Deakin University's clinical exercise laboratory 2 times per week (24 training sessions altogether). Exergaming will consist of simple balance and dual tasking games designed to improve physical function, balance and cognition using a specially designed VR training program. Adherence to the intervention will be monitored using attendance records.

For real tDCS, electrodes placed on the scalp will pass a low-intensity current at 2mA while the participants play the games. For sham tDCS, the device will only provide low-intensity stimulation for 30s before gradually lowering back to zero stimulation.

The testing sessions will last approximately 2hours. Each session consists of a series of static and dynamic balance routines designed to test stability and postural control. Cognitive testing will last approximately 30mins and consist of two validated tasks designed to measure executive function in PD. Additionally, near-infrared spectroscopy (NIRS) will be applied during these tests to measure changes in blood flow of the brain; indicative of brain activation. Finally, brain and spinal excitability, will be tested using transcranial magnetic stimulation (TMS), lasting approximately 30mins. TMS passes a painless electromagnetic pulse through the scalp, inducing a light involuntary contraction of a targeted muscle. For this project we will be targeting muscles of the lower leg, which play a critical role in maintaining upright stance in PD. The level of involuntary activation of these muscles is recorded via EMG surface electrodes as a motor evoked potential (MEP). Differences in MEP sizes from pre to post intervention are indicative of improved brain and spinal excitability.
Intervention code [1] 294650 0
Treatment: Devices
Intervention code [2] 294651 0
Rehabilitation
Intervention code [3] 294669 0
Treatment: Other
Comparator / control treatment
The standard care group (control group) will undertake testing at Deakin University, and will be encouraged to continue with their regular care as prescribed by their physician throughout the duration of the intervention. The control group will be offered the intervention once the trial is complete, pending results of the trial. This option will be extended to participants in the control group 6 months after the intervention groups finish.
Control group
Active

Outcomes
Primary outcome [1] 298183 0
Balance will be assessed using limits of stability and sensory organization tests provided through dynamic posturography (SMART balance master). Additionally, functional (dynamic) balance will be assessed using the timed-up-and-go and 10m walk tests.
Timepoint [1] 298183 0
Pre intervention, mid intervention (6 weeks), cessation of intervention (12 weeks) and in follow-up (12 weeks following completion of intervention)
Secondary outcome [1] 323426 0
Cognitive function will be assessed using the stroop and go, no-go tests of choice inhibition and executive function.
Timepoint [1] 323426 0
Pre intervention, mid intervention (6 weeks), cessation of intervention (12 weeks) and in follow-up (12 weeks following completion of intervention)
Secondary outcome [2] 323427 0
Corticospinal excitability will be assessed using transcranial magnetic stimulation (TMS) over the motor cortex, and electromyography (EMG) attached to the site of activation (tibialis anterior).
Timepoint [2] 323427 0
Pre intervention, mid intervention (6 weeks), cessation of intervention (12 weeks) and in follow-up (12 weeks following completion of intervention)
Secondary outcome [3] 323484 0
Cortical activation will be assessed using near infrared spectroscopy (NIRS), which uses infrared light to penetrate the skull through light emitters attached to the site most responsible for cognition (dorsolateral prefrontal cortex). The infrared light detects changes in haemoglobin concentration of cortical blood during cognitive demanding tasks, and is therefore a direct measure of cortical activation patterns.
Timepoint [3] 323484 0
Pre intervention, mid intervention (6 weeks), cessation of intervention (12 weeks) and in follow-up (12 weeks following completion of the intervention)

Eligibility
Key inclusion criteria
1. Score a minimum of 18 points on the mini mental state examination (MMSE)
2. Complete a general medical questionnaire to ensure no other health complications are present
3. Complete a TMS safety screening questionnaire to ensure no contraindications to TMS are present
4. Provide a statement to declare if they have been diagnosed with PD by a independent neurologist
5. Have a history of 1 or more falls in the last 24 months
6. Present with moderate to severe disease severity as indicated by the Hoehn and Yahr Scale
7. Be on a stable drug regime
8. Not be undertaking physical therapy or strength training for a minimum of 12 months
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Early stage of PD (UPDRS)
2) Severe lower-limb motor impairments (i.e. requires a walking support or wheelchair bound)
3) Previously diagnosed with stroke or dementia
4) Metal implants in the participants head (i.e. deep brain stimulator or aneurysm clips)
5) Other medical conditions or physical disabilities interfering with the participant’s mobility

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)
Central computer randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on dependent outcome variables of static (BBS) and dynamic (TUG) balance in previous studies on exergaming, 33 IPD participants will provide at least 80% power to detect a 15% difference in dynamic and static balance assuming a standard deviation of 10-15% between intervention groups. Instead, a total of 42 IPD participants will be recruited, and allocated evenly across each of the interventional or control groups, to account for a 30% dropout rate.

Statistical analyses will be conducted using Stata Statistical Software v11 (Stata, College Station, TX). A two-way mixed factors analysis of variance (ANOVA) with factors TIME (pre vs during vs post1 vs post2) and TREATMENT (exergaming + sham stimulation vs exergaming + real stimulation) will be used to determine the effect that different direct current stimulation interventions have on brain excitability and balance. Post-hoc analyses using Tukeys test will be applied as appropriate. Pearson’s product correlation coefficient will be also used to measure the level of correlation between clinical outcome measures and brain excitability and activation. Significance will be set at P<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293511 0
University
Name [1] 293511 0
Deakin University
Country [1] 293511 0
Australia
Primary sponsor type
Individual
Name
Wei Peng Teo
Address
Institute for Physical Activity and Nutrition (IPAN)
221 Burwood Highway
Burwood
Victoria 3125 Australia
Country
Australia
Secondary sponsor category [1] 292338 0
None
Name [1] 292338 0
Address [1] 292338 0
Country [1] 292338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294955 0
Deakin University Human Research Ethics Commitee
Ethics committee address [1] 294955 0
221 Burwood Highway
Burwood
Victoria 3125 Australia
Ethics committee country [1] 294955 0
Australia
Date submitted for ethics approval [1] 294955 0
11/04/2016
Approval date [1] 294955 0
02/05/2016
Ethics approval number [1] 294955 0
2016-053

Summary
Brief summary
Parkinson's disease (PD) is a progressive movement disorder that results in a number of cardinal features; resting tremor, progressive slowness of movement and muscle rigidity. Additionally, and perhaps most debilitating, is postural instability, which generally worsens as the disease progresses. Postural instability is known to affect both static and dynamic balance, and is a contributing factor to falls and near-fall related events. Previous literature has suggested a high incidence of falls in PD (with some reporting a 69% falls rate), which often leads to injuries and the need for hospital admission and/or physical rehabilitation. Although medication is the first point of therapy following diagnosis, such pharmacological therapies do little to preserve or improve postural control. Furthermore, many physical therapies (i.e. physiotherapy) often require on-site participation and exercise prescription to be effective, which is not suitable for people who live in rural areas, and often leads to high drop-out rates. Therefore, there is a need for the exploration of efficacious, non-pharmacotherapeutic methods to improve balance of people with PD from within a home setting to enhance compliance rates. As such, using a single randomised controlled intervention, this project aims to investigate the effects of combining virtual reality exercise gaming (exergaming) with a mobile neurological stimulation technique (transcranial direct current stimulation [tDCS]) to improve the balance, cognition and brain function of people with PD in order to reduce the risk of falls and to enhance exercise adherence.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 65566 0
Dr Wei-Peng Teo
Address 65566 0
Institute for Physical Activity and Nutrition (IPAN)
221 Burwood Highway
Burwood
Victoria 3125 Australia
Country 65566 0
Australia
Phone 65566 0
(+61) 3 9244 5229
Fax 65566 0
Email 65566 0
[email protected]
Contact person for public queries
Name 65567 0
Dale Harris
Address 65567 0
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood
Victoria 3125 Australia
Country 65567 0
Australia
Phone 65567 0
+61 478 419 289
Fax 65567 0
Email 65567 0
[email protected]
Contact person for scientific queries
Name 65568 0
Dale Harris
Address 65568 0
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood
Victoria 3125 Australia
Country 65568 0
Australia
Phone 65568 0
+61 478 419 289
Fax 65568 0
Email 65568 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
SourceTitleYear of PublicationDOI
EmbaseConcurrent exergaming and transcranial direct current stimulation to improve balance in people with Parkinson's disease: Study protocol for a randomised controlled trial.2018https://dx.doi.org/10.1186/s13063-018-2773-6
N.B. These documents automatically identified may not have been verified by the study sponsor.