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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Task-orientated training
Transcutaneous electrical nerve stimulation (TENS)
Sham electrical nerve stimulation
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring upper limb, transcutaneous electrical nerve stimulation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

No Intervention

Arm Label

Bilateral TENS (Bi-TENS) group

Unilateral TENS (uni-TENS) group

Placebo group

Control group

Arm 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

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

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

No Active intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
The Range of Motion (ROM) of Upper Limb Joints
With 0° shoulder flexion and 90° elbow flexion, the forearm and wrist will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for wrist flexion/extension. With 90° shoulder flexion and 0° elbow flexion, the forearm will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for elbow flexion/extension. All the subjects will be requested to perform their joint ROM to the best of their abilities.
Motor Activity Log (MAL)
The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview. Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations. Each task was rated from 0 to 5. The score of the 30 activities of daily life were combined to compute the total score of MAL-AOU and MAL-QOM, respectively. Hence, the total score of AOU and QOM component were rated from 0 to 150. The higher MAL-AOU score indicated a higher frequency use of the paretic upper limb, and the higher MAL-QOM score indicated a higher movement quality of the paretic upper limb.
Chinese Version of Community Integration Measure (CIM)
The Chinese version of CIM was used to assess the level of community integration of the subjects. The CIM-C has been shown to have good internal consistency and good test-retest reliability for people with stroke . CIM has 10 items, each item rate from 1-5, giving a minimum score of 10 to a maximum of 50. A higher score indicated a higher level of community integration.
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
EMG signal of Radial Carpi Extensor and Ulnar Carpi Flexor for both affected and unaffected side would be recorded by the surface EMG electrodes when asked the subjects to perform the MVC of wrist extension and flexion for 5s in each trial. Each movement would perform 3 times. The data of the 3 trials will be averaged. The co-contraction ratio would be calculated by the iEMG area of antagonist to total (agonist+antagonist), which would be captured for 0.5s from the window began at 0.25s before and ended at 0.25s after the peak value of MVC.

Full Information

First Posted
April 10, 2017
Last Updated
April 19, 2021
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03112473
Brief Title
Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
Official Title
A Randomized, Controlled Clinical Trial of Upper Limb Training With Bilateral Cutaneous Electrical Stimulation to Improve Upper Limb Functions in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 24, 2016 (Actual)
Primary Completion Date
October 24, 2020 (Actual)
Study Completion Date
October 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
upper limb, transcutaneous electrical nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The participant and outcome assessor were blinded to the group allocation
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral TENS (Bi-TENS) group
Arm Type
Active Comparator
Arm 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
Arm Title
Unilateral TENS (uni-TENS) group
Arm Type
Placebo Comparator
Arm 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 unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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 sham electrical stimulation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No Active intervention
Intervention Type
Behavioral
Intervention Name(s)
Task-orientated training
Intervention Description
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
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
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
Intervention Name(s)
Sham electrical nerve stimulation
Intervention Description
A identical-looking TENS devices that electrical circuit has been disconnected.
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
Description
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 Outcome Measure Information:
Title
Jacket Test (JT)
Description
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)
Title
Maximal Voluntary Contraction (MVC)-Peak Torque
Description
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)
Title
Action Research Arm Test (ARAT)
Description
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.
Time Frame
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
Title
The Range of Motion (ROM) of Upper Limb Joints
Description
With 0° shoulder flexion and 90° elbow flexion, the forearm and wrist will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for wrist flexion/extension. With 90° shoulder flexion and 0° elbow flexion, the forearm will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for elbow flexion/extension. All the subjects will be requested to perform their joint ROM to the best of their abilities.
Time Frame
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
Title
Motor Activity Log (MAL)
Description
The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview. Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations. Each task was rated from 0 to 5. The score of the 30 activities of daily life were combined to compute the total score of MAL-AOU and MAL-QOM, respectively. Hence, the total score of AOU and QOM component were rated from 0 to 150. The higher MAL-AOU score indicated a higher frequency use of the paretic upper limb, and the higher MAL-QOM score indicated a higher movement quality of the paretic upper limb.
Time Frame
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
Title
Chinese Version of Community Integration Measure (CIM)
Description
The Chinese version of CIM was used to assess the level of community integration of the subjects. The CIM-C has been shown to have good internal consistency and good test-retest reliability for people with stroke . CIM has 10 items, each item rate from 1-5, giving a minimum score of 10 to a maximum of 50. A higher score indicated a higher level of community integration.
Time Frame
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
Title
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Description
EMG signal of Radial Carpi Extensor and Ulnar Carpi Flexor for both affected and unaffected side would be recorded by the surface EMG electrodes when asked the subjects to perform the MVC of wrist extension and flexion for 5s in each trial. Each movement would perform 3 times. The data of the 3 trials will be averaged. The co-contraction ratio would be calculated by the iEMG area of antagonist to total (agonist+antagonist), which would be captured for 0.5s from the window began at 0.25s before and ended at 0.25s after the peak value of MVC.
Time Frame
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34852645
Citation
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. Erratum In: Stroke. 2022 Feb;53(2):e65.
Results Reference
derived

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

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