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

The Hong Kong Polytechnic University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Stroke

Interventions

Task-orientated trainingBEHAVIORAL

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)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 stimulationDEVICE

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Fugl Meyer Assessment on Upper Extremity (FMA-UE)

FMA-UE was used for evaluating the upper limb motor control from proximal to distal part of the limb, and voluntary movement from synergistic to isolated in people with stroke. The FMA-UE has shoulder-arm, wrist, hand and coordination and speed subsections. The score of shoulder-arm, wrist, hand and coordination and speed sub-scale are combined to compute the total score. The maximum total score is 66, with 33 items and ordinal scoring from 0 to 2. A higher score of FMA-UE indicated a higher level of upper limb motor control.

Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)

Secondary Outcomes

Jacket Test (JT)

Jacket Test is one of the items in the Physical Performance Test. The subject is required to don a jacket or a cardigan sweater such that it is straight on his or her shoulders, and then remove it completely. The time for completing the task is recorded.(Rueben DB et al, 1990) This Jacket Test (JT) can be used to evaluate the functional mobility of the upper limbs as the test involves abduction of the shoulder joint, flexion and extension of the elbow joint and gripping with the hands.

Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)

Maximal Voluntary Contraction (MVC)-Peak Torque

The force data would be recorded by the self-made load cell. And the mean value peak torque of the joint would be calculated by the force and the length from the wrist joint to the head of 3rd metacarpal.

Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)

Action Research Arm Test (ARAT)

ARAT will be used to assess the 4 aspects of upper limb function(grasp, grip, pinch and gross arm movement). This scale is consistent of 19 items. The quality of performance on each item is rated from 0-3, so the score of ARAT is ranged from 0-57. The score of rasp, grip, pinch and gross arm movement sub-scale are combined to compute the total score. The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. A higher ARAT score indicated a higher upper limb motor function.

Data from ClinicalTrials.gov

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