Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT03112473
Collaborator
(none)
120
1
4
47
2.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The participant and outcome assessor were blinded to the group allocation
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Nov 24, 2016
Actual Primary Completion Date
:
Oct 24, 2020
Actual Study Completion Date
:
Oct 24, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bilateral TENS (Bi-TENS) group 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
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.
Device: Transcutaneous electrical nerve stimulation (TENS)
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
|
| Placebo Comparator: Unilateral TENS (uni-TENS) group 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
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.
Device: Transcutaneous electrical nerve stimulation (TENS)
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
Device: Sham electrical nerve stimulation
A identical-looking TENS devices that electrical circuit has been disconnected.
|
| Placebo Comparator: Placebo group 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
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.
Device: Sham electrical nerve stimulation
A identical-looking TENS devices that electrical circuit has been disconnected.
|
| No Intervention: Control group No Active intervention |
Outcome Measures
Primary Outcome Measures
- Fugl Meyer Assessment on Upper Extremity (FMA-UE) [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 Outcome Measures
- 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)]
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 [Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)]
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) [Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)]
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 [Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)]
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) [Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)]
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) [Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)]
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 [Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The Hong Kong Polytechnic University
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Shamay Ng,
Associate Professor,
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT03112473
Other Study ID Numbers:
- HMRF_SNg
First Posted:
Apr 13, 2017
Last Update Posted:
May 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shamay Ng,
Associate Professor,
The Hong Kong Polytechnic University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb Transcutaneous electrical nerve stimulation (TENS) | 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 Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb Transcutaneous electrical nerve stimulation (TENS) | 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 Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb Sham electrical nerve stimulation | No Active intervention |
| Period Title: Overall Study | ||||
| STARTED | 30 | 30 | 30 | 30 |
| COMPLETED | 30 | 30 | 30 | 30 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group | Total |
|---|---|---|---|---|---|
| Arm/Group Description | All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 7 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 7 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side | All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 7 weeks). All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation | No Active intervention | Total of all reporting groups |
| Overall Participants | 30 | 30 | 30 | 30 | 120 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
23
76.7%
|
21
70%
|
23
76.7%
|
22
73.3%
|
89
74.2%
|
| >=65 years |
7
23.3%
|
9
30%
|
7
23.3%
|
8
26.7%
|
31
25.8%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
60.37
(7.13)
|
62.30
(7.30)
|
61.70
(6.70)
|
61.70
(5.91)
|
61.52
(6.73)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
12
40%
|
13
43.3%
|
9
30%
|
10
33.3%
|
44
36.7%
|
| Male |
18
60%
|
17
56.7%
|
21
70%
|
20
66.7%
|
76
63.3%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
30
100%
|
30
100%
|
30
100%
|
30
100%
|
120
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| Hong Kong |
30
100%
|
30
100%
|
30
100%
|
30
100%
|
120
100%
|
| Fugl-Meyer Assessment of Upper Extremity (units on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [units on a scale] |
37.03
(12.02)
|
41.83
(17.12)
|
38.77
(15.78)
|
43.93
(18.74)
|
40.39
(16.13)
|
Outcome Measures
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 | 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 | 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 |
| Measure Participants | 30 | 30 | 30 | 30 |
| Pre-intervention |
37.03
(12.02)
|
41.83
(17.12)
|
38.77
(15.78)
|
43.93
(18.74)
|
| Mid-intervention |
41.27
(13.38)
|
43.60
(17.21)
|
40.13
(15.41)
|
44.87
(17.25)
|
| Post-intervention |
43.43
(13.73)
|
44.23
(16.12)
|
40.23
(14.97)
|
44.20
(18.16)
|
| 1-month followed up |
42.60
(13.36)
|
42.70
(17.35)
|
40.90
(14.43)
|
45.03
(17.99)
|
| 3-month followed up |
43.17
(13.61)
|
43.17
(18.65)
|
40.60
(14.67)
|
45.23
(17.77)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Nine subjects (Uni-TENS+TOT: 3; Placebo-TENS+TOT: 1; Control: 5) could not complete JT due to difficulty in maintaining the standing position without physical aids. |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 | 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 | 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 |
| Measure Participants | 30 | 27 | 29 | 25 |
| Pre-intervention |
36.51
(12.44)
|
36.98
(22.02)
|
36.87
(17.53)
|
33.36
(21.39)
|
| Mid-intervention |
33.02
(13.66)
|
35.78
(20.92)
|
36.86
(15.53)
|
32.58
(23.41)
|
| Post-intervention |
32.55
(11.70)
|
30.67
(15.66)
|
34.71
(16.08)
|
34.08
(23.55)
|
| 1-month followed-up |
33.35
(12.46)
|
32.83
(20.32)
|
34.24
(18.25)
|
31.47
(21.79)
|
| 3-month followed-up |
32.00
(12.51)
|
32.54
(18.11)
|
34.24
(17.19)
|
31.77
(22.19)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 | 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 | 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 |
| Measure Participants | 30 | 30 | 30 | 30 |
| Peak Torque-wrist flexion-Pre-intervention |
3.69
(1.79)
|
4.51
(2.63)
|
4.86
(2.82)
|
5.13
(2.29)
|
| Peak Torque-wrist flexion-Mid-intervention |
4.40
(1.90)
|
4.77
(2.74)
|
4.71
(2.74)
|
5.35
(2.68)
|
| Peak Torque-wrist flexion-Post-intervention |
5.10
(2.17)
|
4.74
(2.43)
|
4.94
(2.58)
|
5.39
(2.64)
|
| Peak Torque-wrist flexion- 1-month followed up |
4.86
(2.30)
|
4.85
(2.60)
|
5.17
(2.84)
|
5.57
(2.72)
|
| Peak Torque-wrist flexion- 3-month followed up |
5.08
(2.12)
|
4.89
(2.50)
|
5.28
(2.62)
|
5.70
(2.78)
|
| Peak Torque-wrist extension-Pre-intervention |
3.38
(1.95)
|
3.12
(2.36)
|
3.40
(2.17)
|
3.64
(2.64)
|
| Peak Torque-wrist extension-Mid-intervention |
3.62
(1.70)
|
3.10
(2.46)
|
3.41
(2.48)
|
3.55
(2.53)
|
| Peak Torque-wrist extension-Post-intervention |
3.77
(1.70)
|
3.58
(2.74)
|
3.81
(2.62)
|
3.71
(2.39)
|
| Peak Torque-wrist extension- 1-month followed up |
3.87
(1.89)
|
3.67
(2.82)
|
3.61
(2.35)
|
3.81
(2.34)
|
| Peak Torque-wrist extension- 3-month followed |
3.91
(1.98)
|
3.86
(2.76)
|
3.66
(2.86)
|
3.98
(2.67)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 | 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 | 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 |
| Measure Participants | 30 | 30 | 30 | 30 |
| Pre-intervention |
28.70
(20.09)
|
31.73
(20.09)
|
28.30
(21.69)
|
34.97
(21.97)
|
| Mid-intervention |
31.27
(20.86)
|
33.93
(20.27)
|
29.40
(20.85)
|
35.30
(21.61)
|
| Post-intervention |
33.40
(19.77)
|
33.13
(20.80)
|
30.30
(21.65)
|
36.07
(22.85)
|
| 1-month followed-up |
31.33
(19.24)
|
34.90
(19.74)
|
31.03
(21.83)
|
36.77
(21.79)
|
| 3-month followed-up |
32.20
(20.12)
|
33.33
(21.17)
|
30.43
(21.97)
|
36.27
(22.29)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 | 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 | 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 |
| Measure Participants | 30 | 30 | 30 | 30 |
| Elbow-Pre |
76.67
(28.89)
|
85.73
(27.30)
|
82.88
(24.01)
|
90.22
(33.36)
|
| Elbow-Mid |
84.70
(22.96)
|
84.33
(28.58)
|
86.75
(22.64)
|
79.28
(29.33)
|
| Elbow-Post |
87.70
(23.78)
|
88.47
(26.07)
|
83.60
(18.82)
|
86.75
(23.06)
|
| Elbow-1-month followed-up |
84.13
(30.91)
|
84.05
(29.51)
|
81.85
(23.81)
|
89.67
(26.64)
|
| Elbow-3-month followed-up |
85.13
(33.79)
|
89.90
(30.74)
|
81.95
(20.10)
|
87.02
(27.53)
|
| Wrist-Pre |
72.42
(40.84)
|
69.97
(49.52)
|
72.70
(44.04)
|
87.41
(48.28)
|
| Wrist-Mid |
71.43
(36.45)
|
74.77
(47.35)
|
62.23
(50.02)
|
87.72
(40.34)
|
| Wrist-Post |
73.83
(35.51)
|
75.42
(47.96)
|
69.77
(42.35)
|
90.07
(42.02)
|
| Wrist-1-month followed-up |
72.92
(37.84)
|
78.30
(48.23)
|
66.05
(38.46)
|
87.97
(46.11)
|
| Wrist-3-month followed-up |
70.67
(39.57)
|
78.32
(54.34)
|
71.18
(44.39)
|
90.78
(45.25)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 | 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 | 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 |
| Measure Participants | 30 | 30 | 30 | 30 |
| AOU-Pre |
34.03
(30.35)
|
49.72
(47.73)
|
39.20
(40.54)
|
45.28
(34.50)
|
| AOU-Mid |
35.57
(35.59)
|
44.93
(47.92)
|
53.27
(50.99)
|
47.73
(43.91)
|
| AOU-Post |
38.53
(38.86)
|
48.87
(49.56)
|
54.70
(50.15)
|
45.10
(44.62)
|
| AOU-1-month followed-up |
35.95
(31.91)
|
48.68
(49.49)
|
48.58
(50.04)
|
49.25
(50.86)
|
| AOU-3-month followed-up |
39.80
(34.42)
|
58.03
(54.14)
|
50.53
(48.84)
|
46.42
(46.33)
|
| QOM-Pre |
42.10
(36.15)
|
56.92
(49.89)
|
52.42
(45.09)
|
58.00
(43.44)
|
| QOM-Mid |
41.83
(37.57)
|
53.20
(47.32)
|
61.10
(53.46)
|
51.53
(46.79)
|
| QOM-Post |
40.93
(35.97)
|
61.38
(53.73)
|
51.53
(46.76)
|
52.77
(44.83)
|
| QOM-1-month followed-up |
43.05
(35.85)
|
54.00
(51.32)
|
54.88
(53.83)
|
57.13
(53.52)
|
| QOM-3-month followed-up |
43.28
(39.07)
|
59.08
(54.20)
|
54.23
(50.13)
|
57.18
(50.78)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 | 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 | 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 |
| Measure Participants | 30 | 30 | 30 | 30 |
| Pre-intervention |
39.47
(7.51)
|
41.23
(6.89)
|
41.87
(8.02)
|
39.67
(9.21)
|
| Mid-intervention |
41.23
(6.60)
|
39.90
(11.79)
|
42.20
(7.40)
|
38.37
(9.04)
|
| Post-intervention |
40.17
(7.04)
|
41.67
(9.66)
|
42.17
(8.33)
|
39.80
(9.31)
|
| 1-month followed-up |
41.63
(6.96)
|
42.70
(12.92)
|
43.17
(7.00)
|
39.33
(9.08)
|
| 3-month followed-up |
40.10
(7.16)
|
40.23
(10.45)
|
41.03
(7.93)
|
41.10
(8.86)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group |
|---|---|---|---|---|
| Arm/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 Task-orientated training: 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): 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 | 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 Task-orientated training: 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): 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 stimulation: A identical-looking TENS devices that electrical circuit has been disconnected. | 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 Task-orientated training: 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. Sham electrical nerve stimulation: A identical-looking TENS devices that electrical circuit has been disconnected. | No Active intervention |
| Measure Participants | 30 | 30 | 30 | 30 |
| Co-contraction Ratio of Wrist Flexion-pre |
0.28
(0.14)
|
0.24
(0.11)
|
0.25
(0.15)
|
0.24
(0.13)
|
| Co-contraction Ratio of Wrist Flexion-mid |
0.26
(0.13)
|
0.27
(0.13)
|
0.23
(0.11)
|
0.24
(0.13)
|
| Co-contraction Ratio of Wrist Flexion-post |
0.26
(0.14)
|
0.28
(0.12)
|
0.25
(0.12)
|
0.24
(0.12)
|
| Co-contraction Ratio of Wrist Flexion-follow up 1 month |
0.26
(0.16)
|
0.26
(0.11)
|
0.25
(0.10)
|
0.25
(0.13)
|
| Co-contraction Ratio of Wrist Flexion-follow up 3 months |
0.27
(0.16)
|
0.25
(0.11)
|
0.23
(0.15)
|
0.23
(0.11)
|
| Co-contraction Ratio of Wrist Extension-pre |
0.29
(0.16)
|
0.31
(0.23)
|
0.25
(0.15)
|
0.23
(0.18)
|
| Co-contraction Ratio of Wrist Extension-mid |
0.25
(0.12)
|
0.28
(0.20)
|
0.26
(0.15)
|
0.22
(0.18)
|
| Co-contraction Ratio of Wrist Extension-post |
0.27
(0.14)
|
0.28
(0.21)
|
0.28
(0.16)
|
0.27
(0.20)
|
| Co-contraction Ratio of Wrist Extension-follow up 1 month |
0.29
(0.17)
|
0.28
(0.23)
|
0.26
(0.14)
|
0.23
(0.15)
|
| Co-contraction Ratio of Wrist Extension-follow up 3 months |
0.28
(0.18)
|
0.27
(0.18)
|
0.27
(0.15)
|
0.22
(0.14)
|
Adverse Events
| Time Frame | 5 months (from the baseline to the follow up 3 months assessment) | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Baseline: There was no adverse event occurred in baseline, Mid-Intervention, Post-intervention, follow-up 1 month and follow-up 3 month. | |||||||
| Arm/Group Title | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group | ||||
| Arm/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 | 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 | 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 | ||||
All Cause Mortality |
||||||||
| Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | ||||
Serious Adverse Events |
||||||||
| Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | ||||
Limitations/Caveats
The time window of the assessment may not be widen enough to observe the change in all the outcomes.
The sample size may not be large enough provide sufficient power to detect the improvement in all the outcomes.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Prof. Shamay Ng |
|---|---|
| Organization | Department of Rehabilitation Science, The Hong Kong Polytechnic University |
| Phone | 27664889 |
| shamay.ng@polyu.edu.hk |
Responsible Party:
Shamay Ng,
Associate Professor,
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT03112473
Other Study ID Numbers:
- HMRF_SNg
First Posted:
Apr 13, 2017
Last Update Posted:
May 13, 2021
Last Verified:
Apr 1, 2021