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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2022 |
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Main ID: |
NCT02325427 |
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Date of registration:
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21/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Changes in Brain Activity Associated With Upper Limb Motor Recovery
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Scientific title:
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Changes in Cortical Excitability Associated With Upper Limb Motor Recovery - a Study of Neural Strategies Employed in Motor Recovery |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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8 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02325427 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Effie Chew, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University Hospital, Singapore |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female aged 21-80 years;
2. First ever haemorrhagic or ischaemic hemiplegic stroke less than 1 month prior to
study enrollment;
3. Upper extremity impairment of 0-45 out of a maximum score of 66 on the Fugl-Meyer
assessment scale.
4. MMSE>=24.
5. Be able to provide informed consent.
Exclusion Criteria:
pregnancy; cardiac pacemakers; orthodontics (braces); metal implant; history of epilepsy;
sensorimotor disturbance due to other causes other than stroke; uncontrolled medical
conditions including hypertension, diabetes mellitus and unstable angina; major depression
and a history of psychotic disorders.
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Device: tDCS
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Primary Outcome(s)
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Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability
[Time Frame: within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke]
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Secondary Outcome(s)
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Change of upper limb motor function in terms of Modified Ashworth scale for spasticity
[Time Frame: within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke]
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Change of upper limb motor function in terms of Box and block test
[Time Frame: within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke]
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Change of upper limb motor function in terms of Fugl-Meyer Assessment
[Time Frame: within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke]
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Change of upper limb motor function in terms of Manual muscle testing
[Time Frame: within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke]
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Secondary ID(s)
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TMS2014/00358
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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