Clinical trial NCT03112473: Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
Official title: A Randomized, Controlled Clinical Trial of Upper Limb Training With Bilateral Cutaneous Electrical Stimulation to Improve Upper Limb Functions in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: upper limb
transcutaneous electrical nerve stimulation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: On the basis that the combined use of Uni-TENS and TRT is an effective intervention in upper limb recovery, and the advantage of Bi-TENS eliciting extra neural pathway in the intact hemisphere to facilitate the motor recovery, There is a research gap in whether the Bi-TENS over both the paretic and non-paretic limbs could probably augment the treatment effects of TOT in upper limb motor control in people with stroke.

Detailed description: The purpose of this study is to determine whether Bi-TENS+TOT was superior to Uni-TENS+TOT, Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.

The null hypothesis will be that Bi-TENS+TOT is not significantly different from Uni-TENS+TOT,Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.

Eligibility criteria: Inclusion Criteria:

* Subjects will be recruited from local self-help groups through poster advertising.
* Subjects will be included if they are between 50 and 80 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
* have volitional control of the non-paretic arm and at least minimal antigravity movement in the shoulder of the paretic arm,
* have at least 5º in wrist extension in the antigravity position,
* score \> 6 out of 10 in the Abbreviated Mental Test, and
* are able to follow instructions and give informed consent.

Exclusion Criteria:

* • have any additional medical, cardiovascular or orthopedic condition

  * use a cardiac pacemaker
  * have receptive dysphasia
  * have a significant upper limb peripheral neuropathy
  * are involved in drug studies or other clinical trials, or
  * have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm, and
  * have a skin allergy that would prevent electrical stimulation.

Primary outcomes:
measure: Fugl Meyer Assessment on Upper Extremity (FMA-UE)
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
Secondary outcomes:
measure: Jacket Test (JT)
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
measure: Maximal Voluntary Contraction (MVC)-Peak Torque
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
measure: Action Research Arm Test (ARAT)
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
measure: The Range of Motion (ROM) of Upper Limb Joints
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
measure: Motor Activity Log (MAL)
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
measure: Chinese Version of Community Integration Measure (CIM)
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
measure: Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
timeFrame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
citation: Chen P, Liu TW, Kwong PWH, Lai CKY, Chung RCK, Tsoh J, Ng SSM. Bilateral Transcutaneous Electrical Nerve Stimulation Improves Upper Limb Motor Recovery in Stroke: A Randomized Controlled Trial. Stroke. 2022 Apr;53(4):1134-1140. doi: 10.1161/STROKEAHA.121.036895. Epub 2021 Dec 2.