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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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12 December 2020 |
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Main ID: |
NCT03035162 |
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Date of registration:
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25/01/2017 |
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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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Dual-hemisphere Transcranial Direct Current Stimulation on Lower Limb Motor Functions After Stroke
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Scientific title:
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Dual-hemisphere Transcranial Direct Current Stimulation on Lower Limb Motor Functions After Stroke |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03035162 |
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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: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age range 18-75 years.
2. First ever-ischemic lesion in the territory of middle cerebral artery or anterior
cerebral artery. CT scan/MRI result is thus required.
3. Sub acute phase of stroke (less than 6 months)
4. Able to sit-to-stand and stand-to-sit independently
5. Able to walk without physical assistance at least 6 m
6. Free of any neurological antecedent, unstable medical conditions or condition that may
increase the risk of stimulation such as epilepsy; although tDCS is believed to induce
less or no risk of seizure and epileptic seizure have never been reported in tDCS
study even in a study with active epilepsy (Fregni et al., 2006).
Exclusion Criteria:
1. Pre-stroke disability
2. Pregnant
3. Be unable to understand the instruction
4. No clear neurological antecedent history or psychiatric disorder
5. Excessive pain in any joint of the paretic limb (numerical pain rating score > 7)
6. Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker
7. Subjects are participating in the other protocol or receiving alternative treatment
such as acupuncture
Age minimum:
18 Years
Age maximum:
75 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: Transcranial direct current stimulation
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Primary Outcome(s)
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Five-Times-Sit-To-Stand test (FTSST)
[Time Frame: 5 minutes]
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Timed Up & Go test (TUG)
[Time Frame: 5 minutes]
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Strength
[Time Frame: 15 minutes]
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Secondary ID(s)
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MU-CIRB 2016/048.0704
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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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