NCT03112473

Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke

A Randomized, Controlled Clinical Trial of Upper Limb Training With Bilateral Cutaneous Electrical Stimulation to Improve Upper Limb Functions in Patients With Chronic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Task-orientated training	Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment. In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
DEVICE	Transcutaneous electrical nerve stimulation (TENS)	The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY\&REHABILITION CO., LTD, Tokyo, Japan). The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study
DEVICE	Sham electrical nerve stimulation	A identical-looking TENS devices that electrical circuit has been disconnected.

Timeline

• Start date: 2016-11-24
• Primary completion: 2020-10-24
• Completion: 2020-10-24
• First posted: 2017-04-13
• Last updated: 2021-05-13
• Results posted: 2021-04-20

Locations

1 site across 1 country: Hong Kong