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

NCT03112473 | Completed Results

• 1 other identifier: HMRF_SNg
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

upper limb; transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

Study Arms (4)

Bilateral TENS (Bi-TENS) group

ACTIVE COMPARATOR

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

Behavioral: Task-orientated training; Device: Transcutaneous electrical nerve stimulation (TENS)

Unilateral TENS (uni-TENS) group

PLACEBO COMPARATOR

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

Behavioral: Task-orientated training; Device: Transcutaneous electrical nerve stimulation (TENS); Device: Sham electrical nerve stimulation

Placebo group

PLACEBO COMPARATOR

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

Behavioral: Task-orientated training; Device: Sham electrical nerve stimulation

Control group

NO INTERVENTION

No Active intervention

Interventions

Task-orientated training 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.

Bilateral TENS (Bi-TENS) group; Placebo group; Unilateral TENS (uni-TENS) group

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

Bilateral TENS (Bi-TENS) group; Unilateral TENS (uni-TENS) group

Sham electrical nerve stimulation DEVICE

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

Placebo group; Unilateral TENS (uni-TENS) group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 34852645 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

1. The time window of the assessment may not be widen enough to observe the change in all the outcomes. 2. The sample size may not be large enough provide sufficient power to detect the improvement in all the outcomes.

Results Point of Contact

• Title: Prof. Shamay Ng
• Organization: Department of Rehabilitation Science, The Hong Kong Polytechnic University

shamay.ng@polyu.edu.hk

27664889

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and outcome assessor were blinded to the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: November 24, 2016
• Primary Completion: October 24, 2020
• Study Completion: October 24, 2020
• Last Updated: May 13, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)