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

The Hong Kong Polytechnic University

Status

Completed

Conditions

Stroke

Treatments

Device: Transcutaneous electrical nerve stimulation (TENS)

Device: Sham electrical nerve stimulation

Behavioral: Task-orientated training

Study type

Interventional

Funder types

Other

Identifiers

NCT03112473

HMRF_SNg

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 4 patient groups, including a placebo group

Bilateral TENS (Bi-TENS) group

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS)

Behavioral: Task-orientated training

Unilateral TENS (uni-TENS) group

Placebo Comparator group

Description:

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS)

Behavioral: Task-orientated training

Device: Sham electrical nerve stimulation

Placebo group

Placebo Comparator group