A Randomized, Controlled Clinical Trial of Upper Limb Training With Bilateral Cutaneous Electrical Stimulation to Improve Upper Limb Functions in Patients With Chronic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- The Hong Kong Polytechnic University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Fugl Meyer Assessment on Upper Extremity (FMA-UE)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Shamay Ng
Associate Professor
The Hong Kong Polytechnic University
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.
Outcomes
Primary Outcomes
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
Time Frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
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.
Secondary Outcomes
- Action Research Arm Test (ARAT)(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Motor Activity Log (MAL)(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Chinese Version of Community Integration Measure (CIM)(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- Jacket Test (JT)(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(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))
- The Range of Motion (ROM) of Upper Limb Joints(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)-Cocontraction Ratio(Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks))