Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke
NCT ID: NCT02152813
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2014-05-31
2018-01-31
Brief Summary
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The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.
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Detailed Description
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The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1. Bilateral TENS (Bi-TENS) group
Subjects having bilateral electrical stimulation and task-orientated exercises
TENS and Task-orientated training
All subjects will undergo 16 sessions of their assigned intervention (60 minutes, twice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented lower limb training (TOT) with electrical stimulation protocol assigned concurrently:
Unilateral TENS (Uni-TENS) group
Subjects having unilateral TENS over their affected lower limb only, and task-oriented exercises
TENS and Task-orientated training
All subjects will undergo 16 sessions of their assigned intervention (60 minutes, twice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented lower limb training (TOT) with electrical stimulation protocol assigned concurrently:
Interventions
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TENS and Task-orientated training
All subjects will undergo 16 sessions of their assigned intervention (60 minutes, twice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented lower limb training (TOT) with electrical stimulation protocol assigned concurrently:
Eligibility Criteria
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Inclusion Criteria
* Subjects will be included if they (1) are between 55 and 85 years of age
* Have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography within the previous 1 to 10 years
* Are able to walk 3 metres independently with or without a walking aid
* Are able to score \> 6 out of 10 on the abbreviated mental test
* Are able to follow instructions and give informed consent
* Have no skin allergy which would prevent electrical stimulation.
Exclusion Criteria
* Use a cardiac pacemaker
* Have receptive dysphasia
* Have significant lower limb peripheral neuropathy (e.g. diabetic polyneuropathy)
* Are involved in drug studies or other clinical trials.
55 Years
85 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Shamay Ng
Associate Professor
Locations
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The Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Countries
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References
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Kwong PWH, Ng GYF, Chung RCK, Ng SSM. Bilateral Transcutaneous Electrical Nerve Stimulation Improves Lower-Limb Motor Function in Subjects With Chronic Stroke: A Randomized Controlled Trial. J Am Heart Assoc. 2018 Feb 8;7(4):e007341. doi: 10.1161/JAHA.117.007341.
Other Identifiers
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2014_GRF_NG
Identifier Type: -
Identifier Source: org_study_id
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