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

NCT ID: NCT03112473

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-24
• Study Completion Date: 2020-10-24

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bilateral TENS (Bi-TENS) group

All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation

Group Type: ACTIVE_COMPARATOR

Task-orientated training

Intervention Type: BEHAVIORAL

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.

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

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

Unilateral TENS (uni-TENS) group

All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side

Group Type: PLACEBO_COMPARATOR

Task-orientated training

Intervention Type: BEHAVIORAL

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.

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

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

Sham electrical nerve stimulation

Intervention Type: DEVICE

A identical-looking TENS devices that electrical circuit has been disconnected.

Placebo group

All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation

Group Type: PLACEBO_COMPARATOR

Task-orientated training

Intervention Type: BEHAVIORAL

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.

Sham electrical nerve stimulation

Intervention Type: DEVICE

A identical-looking TENS devices that electrical circuit has been disconnected.

Control group

No Active intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: DEVICE

Sham electrical nerve stimulation

A identical-looking TENS devices that electrical circuit has been disconnected.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Shamay Ng

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 34852645 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

HMRF_SNg

Identifier Type: -

Identifier Source: org_study_id