Clinical trial NCT02152813: Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke
Official title: Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke: a Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Electrical stimulation, exercise, stroke , rehabilitation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS + task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke.

The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.

Detailed description: This proposed study aims to compare the effects of unilateral and bilateral transcutaneous electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS + task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength, co-ordination, dynamic standing balance, walking performance, and functional mobility in patients with chronic stroke.

The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not significantly different in promoting the recovery of these functions.

Eligibility criteria: Inclusion Criteria:

* Subjects will be recruited from local self-help groups through poster advertising. \\
* 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:

* Subjects will be excluded if they have any additional medical, cardiovascular or orthopedic condition that would hinder proper treatment or assessment
* 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.

Primary outcomes:
measure: Muscle strength of lower limb
timeFrame: 4 years
Secondary outcomes:
measure: Dynamic standing balance
timeFrame: 4 years
Other outcomes:
measure: Lower-extremity motor coordination
timeFrame: 4 years
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
citation: 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.