Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000101785
Ethics application status
Approved
Date submitted
28/10/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Combining Effects of transcranial Direct Current Stimulation (tDCS) and Treadmill Training on Dual Task Walking and Brain Activity- Exploration of People With Parkinson's Disease
Scientific title
Combining Effects of tDCS and Treadmill Training on Dual Task Walking and Brain Activity- Exploration of People With Parkinson's Disease
Secondary ID [1] 305625 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 324054 0
Condition category
Condition code
Neurological 321569 321569 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in both groups will receive tDCS followed by treadmill training 3 sessions a week for 4 weeks (total 12 sessions).
All the tDCS interventions will be administered by same researcher assistant. We will apply anodal transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) of dominant hemisphere (according to EEG 10/20 system), and cathodal electrode over the contralateral supraorbital area as a reference. A constant current of 2 mA will be applied for 20 mins in experimental group.

Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight).
-During treadmill training, all participants will be instructed and supervised by a registered physical therapist.
-Session attendance, and drop out will be monitored and record by a session attendance checklist for each client.
Intervention code [1] 322026 0
Rehabilitation
Comparator / control treatment
Control group will receive sham tDCS followed by treadmill training.
For sham stimulation, the electrodes will be placed on the same placements as those of the real tDCS, However, the stimulator will be turned off after 20 seconds of stimulation (ramping up and down for 10 seconds). Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight).
Control group
Active

Outcomes
Primary outcome [1] 329331 0
Cognitive dual task walking.
Measured by a GAITRite system.
Gait parameters: speed, cadence, stride time, stride length, and coefficients of variation (CV) of stride time and stride length.
Timepoint [1] 329331 0
Measured before and one day after the intervention
Primary outcome [2] 329332 0
Motor dual task walking.
Measured by a GAITRite system.
Gait parameters: speed, cadence, stride time, stride length, and coefficients of variation (CV) of stride time and stride length.
Timepoint [2] 329332 0
Measured before and one day after the intervention
Secondary outcome [1] 402163 0
Corticomotor activity
Corticomotor activity was measured using transcranial magnetic stimulation (TMS).
-The target muscle: bilateral tibialis anterior muscles
-TMS Parameters: Resting motor threshold(RMT), cortical silent period (CSP), motor evoked potentials (MEP),short interval intracortical inhibition (SICI)
Timepoint [1] 402163 0
measured before and one day after the intervention
Secondary outcome [2] 402164 0
Single walking
Measured by a GAITRite system. Gait parameters of interest were speed, cadence, stride time, stride length, and coefficients of variation (CV) of stride time and stride length.
Timepoint [2] 402164 0
Measured before and one day after the intervention
Secondary outcome [3] 402165 0
Timed Up and Go Test
(measured dynamic balance and functional mobility)
Timepoint [3] 402165 0
Measured before and one day after the intervention
Secondary outcome [4] 402166 0
Trail-making test
(measured executive function)
Timepoint [4] 402166 0
Measured before and one day after the intervention
Secondary outcome [5] 402167 0
Montreal Cognitive Assessment
(measured global cognitive function)
Timepoint [5] 402167 0
Measured before and one day after the intervention
Secondary outcome [6] 402168 0
PDQ-39 (The 39 Item Parkinson's Disease Questionnaire)
Timepoint [6] 402168 0
Measured before and one day after the intervention

Eligibility
Key inclusion criteria
Inclusion Criteria:
(1) diagnosed as idiopathic Parkinson's disease (PD)
(2) stage 1 to 3 on the Hoehn and Yahr scale
(3) ability to walk independently for at least 10 m without use of walking aids
(4) stable medical condition
(5) mini-mental state examination (MMSE) score of>24
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
(1) history of diseases or conditions known to interfere with participating the study (e.g., active cancer, epilepsy or metal implants in the brain)
(2) history of using central nervous system medications other than for PD, e.g. anti-epileptic or anti-depressant drugs in recent month.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment outside Australia
Country [1] 24240 0
Taiwan, Province Of China
State/province [1] 24240 0

Funding & Sponsors
Funding source category [1] 309985 0
Government body
Name [1] 309985 0
Ministry of Science and Technology, Taiwan
Country [1] 309985 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Professor Ray-Yau Wang
Address
Department of Physical Therapy and Assistive Technology
National Yang Ming Chiao Tung University
Biomedical Science and Engineering building, No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 311034 0
None
Name [1] 311034 0
Address [1] 311034 0
Country [1] 311034 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309694 0
Institutional Review Board, Taipei Veterans General Hospital
Ethics committee address [1] 309694 0
Ethics committee country [1] 309694 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 309694 0
Approval date [1] 309694 0
05/07/2021
Ethics approval number [1] 309694 0

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

Contacts
Principal investigator
Name 115066 0
Prof Ray-Yau Wang
Address 115066 0
Department of Physical Therapy and Assistive Technology
National Yang Ming Chiao Tung University
Biomedical Science and Engineering building, No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 115066 0
Taiwan, Province Of China
Phone 115066 0
+886228267210
Fax 115066 0
Email 115066 0
[email protected]
Contact person for public queries
Name 115067 0
Ray-Yau Wang
Address 115067 0
Department of Physical Therapy and Assistive Technology
National Yang Ming Chiao Tung University
Biomedical Science and Engineering building, No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 115067 0
Taiwan, Province Of China
Phone 115067 0
+886228267210
Fax 115067 0
Email 115067 0
[email protected]
Contact person for scientific queries
Name 115068 0
Ray-Yau Wang
Address 115068 0
Department of Physical Therapy and Assistive Technology
National Yang Ming Chiao Tung University
Biomedical Science and Engineering building, No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country 115068 0
Taiwan, Province Of China
Phone 115068 0
+886228267210
Fax 115068 0
Email 115068 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.