Trial Outcomes & Findings for Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke (NCT NCT03112473)
NCT ID: NCT03112473
Last Updated: 2021-05-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
Results posted on
2021-05-13
Participant Flow
Participant milestones
| Measure |
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
Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb
Transcutaneous electrical nerve stimulation (TENS)
|
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
Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb
Transcutaneous electrical nerve stimulation (TENS)
|
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
Task-orientated training: Bi/Uni/Placebo TENS and Task-orientated training on upper limb
Sham electrical nerve stimulation
|
Control Group
No Active intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
Baseline characteristics by cohort
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Age, Continuous
|
60.37 years
STANDARD_DEVIATION 7.13 • n=5 Participants
|
62.30 years
STANDARD_DEVIATION 7.30 • n=7 Participants
|
61.70 years
STANDARD_DEVIATION 6.70 • n=5 Participants
|
61.70 years
STANDARD_DEVIATION 5.91 • n=4 Participants
|
61.52 years
STANDARD_DEVIATION 6.73 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Hong Kong
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
120 participants
n=21 Participants
|
|
Fugl-Meyer Assessment of Upper Extremity
|
37.03 units on a scale
STANDARD_DEVIATION 12.02 • n=5 Participants
|
41.83 units on a scale
STANDARD_DEVIATION 17.12 • n=7 Participants
|
38.77 units on a scale
STANDARD_DEVIATION 15.78 • n=5 Participants
|
43.93 units on a scale
STANDARD_DEVIATION 18.74 • n=4 Participants
|
40.39 units on a scale
STANDARD_DEVIATION 16.13 • n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
|---|---|---|---|---|
|
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
Pre-intervention
|
37.03 score on a scale
Standard Deviation 12.02
|
41.83 score on a scale
Standard Deviation 17.12
|
38.77 score on a scale
Standard Deviation 15.78
|
43.93 score on a scale
Standard Deviation 18.74
|
|
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
Mid-intervention
|
41.27 score on a scale
Standard Deviation 13.38
|
43.60 score on a scale
Standard Deviation 17.21
|
40.13 score on a scale
Standard Deviation 15.41
|
44.87 score on a scale
Standard Deviation 17.25
|
|
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
Post-intervention
|
43.43 score on a scale
Standard Deviation 13.73
|
44.23 score on a scale
Standard Deviation 16.12
|
40.23 score on a scale
Standard Deviation 14.97
|
44.20 score on a scale
Standard Deviation 18.16
|
|
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
1-month followed up
|
42.60 score on a scale
Standard Deviation 13.36
|
42.70 score on a scale
Standard Deviation 17.35
|
40.90 score on a scale
Standard Deviation 14.43
|
45.03 score on a scale
Standard Deviation 17.99
|
|
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
3-month followed up
|
43.17 score on a scale
Standard Deviation 13.61
|
43.17 score on a scale
Standard Deviation 18.65
|
40.60 score on a scale
Standard Deviation 14.67
|
45.23 score on a scale
Standard Deviation 17.77
|
SECONDARY outcome
Timeframe: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)Population: 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.
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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=27 Participants
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
|
Placebo Group
n=29 Participants
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
|
Control Group
n=25 Participants
No Active intervention
|
|---|---|---|---|---|
|
Jacket Test (JT)
Pre-intervention
|
36.51 second
Standard Deviation 12.44
|
36.98 second
Standard Deviation 22.02
|
36.87 second
Standard Deviation 17.53
|
33.36 second
Standard Deviation 21.39
|
|
Jacket Test (JT)
Mid-intervention
|
33.02 second
Standard Deviation 13.66
|
35.78 second
Standard Deviation 20.92
|
36.86 second
Standard Deviation 15.53
|
32.58 second
Standard Deviation 23.41
|
|
Jacket Test (JT)
Post-intervention
|
32.55 second
Standard Deviation 11.70
|
30.67 second
Standard Deviation 15.66
|
34.71 second
Standard Deviation 16.08
|
34.08 second
Standard Deviation 23.55
|
|
Jacket Test (JT)
1-month followed-up
|
33.35 second
Standard Deviation 12.46
|
32.83 second
Standard Deviation 20.32
|
34.24 second
Standard Deviation 18.25
|
31.47 second
Standard Deviation 21.79
|
|
Jacket Test (JT)
3-month followed-up
|
32.00 second
Standard Deviation 12.51
|
32.54 second
Standard Deviation 18.11
|
34.24 second
Standard Deviation 17.19
|
31.77 second
Standard Deviation 22.19
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
|---|---|---|---|---|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist flexion-Pre-intervention
|
3.69 N*m
Standard Deviation 1.79
|
4.51 N*m
Standard Deviation 2.63
|
4.86 N*m
Standard Deviation 2.82
|
5.13 N*m
Standard Deviation 2.29
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist flexion-Mid-intervention
|
4.40 N*m
Standard Deviation 1.90
|
4.77 N*m
Standard Deviation 2.74
|
4.71 N*m
Standard Deviation 2.74
|
5.35 N*m
Standard Deviation 2.68
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist flexion-Post-intervention
|
5.10 N*m
Standard Deviation 2.17
|
4.74 N*m
Standard Deviation 2.43
|
4.94 N*m
Standard Deviation 2.58
|
5.39 N*m
Standard Deviation 2.64
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist flexion- 1-month followed up
|
4.86 N*m
Standard Deviation 2.30
|
4.85 N*m
Standard Deviation 2.60
|
5.17 N*m
Standard Deviation 2.84
|
5.57 N*m
Standard Deviation 2.72
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist flexion- 3-month followed up
|
5.08 N*m
Standard Deviation 2.12
|
4.89 N*m
Standard Deviation 2.50
|
5.28 N*m
Standard Deviation 2.62
|
5.70 N*m
Standard Deviation 2.78
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist extension-Pre-intervention
|
3.38 N*m
Standard Deviation 1.95
|
3.12 N*m
Standard Deviation 2.36
|
3.40 N*m
Standard Deviation 2.17
|
3.64 N*m
Standard Deviation 2.64
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist extension-Mid-intervention
|
3.62 N*m
Standard Deviation 1.70
|
3.10 N*m
Standard Deviation 2.46
|
3.41 N*m
Standard Deviation 2.48
|
3.55 N*m
Standard Deviation 2.53
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist extension-Post-intervention
|
3.77 N*m
Standard Deviation 1.70
|
3.58 N*m
Standard Deviation 2.74
|
3.81 N*m
Standard Deviation 2.62
|
3.71 N*m
Standard Deviation 2.39
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist extension- 1-month followed up
|
3.87 N*m
Standard Deviation 1.89
|
3.67 N*m
Standard Deviation 2.82
|
3.61 N*m
Standard Deviation 2.35
|
3.81 N*m
Standard Deviation 2.34
|
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Peak Torque-wrist extension- 3-month followed
|
3.91 N*m
Standard Deviation 1.98
|
3.86 N*m
Standard Deviation 2.76
|
3.66 N*m
Standard Deviation 2.86
|
3.98 N*m
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
|---|---|---|---|---|
|
Action Research Arm Test (ARAT)
Pre-intervention
|
28.70 score on a scale
Standard Deviation 20.09
|
31.73 score on a scale
Standard Deviation 20.09
|
28.30 score on a scale
Standard Deviation 21.69
|
34.97 score on a scale
Standard Deviation 21.97
|
|
Action Research Arm Test (ARAT)
Mid-intervention
|
31.27 score on a scale
Standard Deviation 20.86
|
33.93 score on a scale
Standard Deviation 20.27
|
29.40 score on a scale
Standard Deviation 20.85
|
35.30 score on a scale
Standard Deviation 21.61
|
|
Action Research Arm Test (ARAT)
Post-intervention
|
33.40 score on a scale
Standard Deviation 19.77
|
33.13 score on a scale
Standard Deviation 20.80
|
30.30 score on a scale
Standard Deviation 21.65
|
36.07 score on a scale
Standard Deviation 22.85
|
|
Action Research Arm Test (ARAT)
1-month followed-up
|
31.33 score on a scale
Standard Deviation 19.24
|
34.90 score on a scale
Standard Deviation 19.74
|
31.03 score on a scale
Standard Deviation 21.83
|
36.77 score on a scale
Standard Deviation 21.79
|
|
Action Research Arm Test (ARAT)
3-month followed-up
|
32.20 score on a scale
Standard Deviation 20.12
|
33.33 score on a scale
Standard Deviation 21.17
|
30.43 score on a scale
Standard Deviation 21.97
|
36.27 score on a scale
Standard Deviation 22.29
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
|---|---|---|---|---|
|
The Range of Motion (ROM) of Upper Limb Joints
Elbow-Pre
|
76.67 degree
Standard Deviation 28.89
|
85.73 degree
Standard Deviation 27.30
|
82.88 degree
Standard Deviation 24.01
|
90.22 degree
Standard Deviation 33.36
|
|
The Range of Motion (ROM) of Upper Limb Joints
Elbow-Mid
|
84.70 degree
Standard Deviation 22.96
|
84.33 degree
Standard Deviation 28.58
|
86.75 degree
Standard Deviation 22.64
|
79.28 degree
Standard Deviation 29.33
|
|
The Range of Motion (ROM) of Upper Limb Joints
Elbow-Post
|
87.70 degree
Standard Deviation 23.78
|
88.47 degree
Standard Deviation 26.07
|
83.60 degree
Standard Deviation 18.82
|
86.75 degree
Standard Deviation 23.06
|
|
The Range of Motion (ROM) of Upper Limb Joints
Elbow-1-month followed-up
|
84.13 degree
Standard Deviation 30.91
|
84.05 degree
Standard Deviation 29.51
|
81.85 degree
Standard Deviation 23.81
|
89.67 degree
Standard Deviation 26.64
|
|
The Range of Motion (ROM) of Upper Limb Joints
Elbow-3-month followed-up
|
85.13 degree
Standard Deviation 33.79
|
89.90 degree
Standard Deviation 30.74
|
81.95 degree
Standard Deviation 20.10
|
87.02 degree
Standard Deviation 27.53
|
|
The Range of Motion (ROM) of Upper Limb Joints
Wrist-Pre
|
72.42 degree
Standard Deviation 40.84
|
69.97 degree
Standard Deviation 49.52
|
72.70 degree
Standard Deviation 44.04
|
87.41 degree
Standard Deviation 48.28
|
|
The Range of Motion (ROM) of Upper Limb Joints
Wrist-Mid
|
71.43 degree
Standard Deviation 36.45
|
74.77 degree
Standard Deviation 47.35
|
62.23 degree
Standard Deviation 50.02
|
87.72 degree
Standard Deviation 40.34
|
|
The Range of Motion (ROM) of Upper Limb Joints
Wrist-Post
|
73.83 degree
Standard Deviation 35.51
|
75.42 degree
Standard Deviation 47.96
|
69.77 degree
Standard Deviation 42.35
|
90.07 degree
Standard Deviation 42.02
|
|
The Range of Motion (ROM) of Upper Limb Joints
Wrist-1-month followed-up
|
72.92 degree
Standard Deviation 37.84
|
78.30 degree
Standard Deviation 48.23
|
66.05 degree
Standard Deviation 38.46
|
87.97 degree
Standard Deviation 46.11
|
|
The Range of Motion (ROM) of Upper Limb Joints
Wrist-3-month followed-up
|
70.67 degree
Standard Deviation 39.57
|
78.32 degree
Standard Deviation 54.34
|
71.18 degree
Standard Deviation 44.39
|
90.78 degree
Standard Deviation 45.25
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
|---|---|---|---|---|
|
Motor Activity Log (MAL)
AOU-Pre
|
34.03 score on a scale
Standard Deviation 30.35
|
49.72 score on a scale
Standard Deviation 47.73
|
39.20 score on a scale
Standard Deviation 40.54
|
45.28 score on a scale
Standard Deviation 34.50
|
|
Motor Activity Log (MAL)
AOU-Mid
|
35.57 score on a scale
Standard Deviation 35.59
|
44.93 score on a scale
Standard Deviation 47.92
|
53.27 score on a scale
Standard Deviation 50.99
|
47.73 score on a scale
Standard Deviation 43.91
|
|
Motor Activity Log (MAL)
AOU-Post
|
38.53 score on a scale
Standard Deviation 38.86
|
48.87 score on a scale
Standard Deviation 49.56
|
54.70 score on a scale
Standard Deviation 50.15
|
45.10 score on a scale
Standard Deviation 44.62
|
|
Motor Activity Log (MAL)
AOU-1-month followed-up
|
35.95 score on a scale
Standard Deviation 31.91
|
48.68 score on a scale
Standard Deviation 49.49
|
48.58 score on a scale
Standard Deviation 50.04
|
49.25 score on a scale
Standard Deviation 50.86
|
|
Motor Activity Log (MAL)
AOU-3-month followed-up
|
39.80 score on a scale
Standard Deviation 34.42
|
58.03 score on a scale
Standard Deviation 54.14
|
50.53 score on a scale
Standard Deviation 48.84
|
46.42 score on a scale
Standard Deviation 46.33
|
|
Motor Activity Log (MAL)
QOM-Pre
|
42.10 score on a scale
Standard Deviation 36.15
|
56.92 score on a scale
Standard Deviation 49.89
|
52.42 score on a scale
Standard Deviation 45.09
|
58.00 score on a scale
Standard Deviation 43.44
|
|
Motor Activity Log (MAL)
QOM-Mid
|
41.83 score on a scale
Standard Deviation 37.57
|
53.20 score on a scale
Standard Deviation 47.32
|
61.10 score on a scale
Standard Deviation 53.46
|
51.53 score on a scale
Standard Deviation 46.79
|
|
Motor Activity Log (MAL)
QOM-Post
|
40.93 score on a scale
Standard Deviation 35.97
|
61.38 score on a scale
Standard Deviation 53.73
|
51.53 score on a scale
Standard Deviation 46.76
|
52.77 score on a scale
Standard Deviation 44.83
|
|
Motor Activity Log (MAL)
QOM-1-month followed-up
|
43.05 score on a scale
Standard Deviation 35.85
|
54.00 score on a scale
Standard Deviation 51.32
|
54.88 score on a scale
Standard Deviation 53.83
|
57.13 score on a scale
Standard Deviation 53.52
|
|
Motor Activity Log (MAL)
QOM-3-month followed-up
|
43.28 score on a scale
Standard Deviation 39.07
|
59.08 score on a scale
Standard Deviation 54.20
|
54.23 score on a scale
Standard Deviation 50.13
|
57.18 score on a scale
Standard Deviation 50.78
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
|---|---|---|---|---|
|
Chinese Version of Community Integration Measure (CIM)
1-month followed-up
|
41.63 score on a scale
Standard Deviation 6.96
|
42.70 score on a scale
Standard Deviation 12.92
|
43.17 score on a scale
Standard Deviation 7.00
|
39.33 score on a scale
Standard Deviation 9.08
|
|
Chinese Version of Community Integration Measure (CIM)
Pre-intervention
|
39.47 score on a scale
Standard Deviation 7.51
|
41.23 score on a scale
Standard Deviation 6.89
|
41.87 score on a scale
Standard Deviation 8.02
|
39.67 score on a scale
Standard Deviation 9.21
|
|
Chinese Version of Community Integration Measure (CIM)
Mid-intervention
|
41.23 score on a scale
Standard Deviation 6.60
|
39.90 score on a scale
Standard Deviation 11.79
|
42.20 score on a scale
Standard Deviation 7.40
|
38.37 score on a scale
Standard Deviation 9.04
|
|
Chinese Version of Community Integration Measure (CIM)
Post-intervention
|
40.17 score on a scale
Standard Deviation 7.04
|
41.67 score on a scale
Standard Deviation 9.66
|
42.17 score on a scale
Standard Deviation 8.33
|
39.80 score on a scale
Standard Deviation 9.31
|
|
Chinese Version of Community Integration Measure (CIM)
3-month followed-up
|
40.10 score on a scale
Standard Deviation 7.16
|
40.23 score on a scale
Standard Deviation 10.45
|
41.03 score on a scale
Standard Deviation 7.93
|
41.10 score on a scale
Standard Deviation 8.86
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bilateral TENS (Bi-TENS) Group
n=30 Participants
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
|
Unilateral TENS (Uni-TENS) Group
n=30 Participants
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
|
Placebo Group
n=30 Participants
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
|
Control Group
n=30 Participants
No Active intervention
|
|---|---|---|---|---|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Extension-post
|
0.27 ratio
Standard Deviation 0.14
|
0.28 ratio
Standard Deviation 0.21
|
0.28 ratio
Standard Deviation 0.16
|
0.27 ratio
Standard Deviation 0.20
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Extension-follow up 1 month
|
0.29 ratio
Standard Deviation 0.17
|
0.28 ratio
Standard Deviation 0.23
|
0.26 ratio
Standard Deviation 0.14
|
0.23 ratio
Standard Deviation 0.15
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Flexion-pre
|
0.28 ratio
Standard Deviation 0.14
|
0.24 ratio
Standard Deviation 0.11
|
0.25 ratio
Standard Deviation 0.15
|
0.24 ratio
Standard Deviation 0.13
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Flexion-mid
|
0.26 ratio
Standard Deviation 0.13
|
0.27 ratio
Standard Deviation 0.13
|
0.23 ratio
Standard Deviation 0.11
|
0.24 ratio
Standard Deviation 0.13
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Flexion-post
|
0.26 ratio
Standard Deviation 0.14
|
0.28 ratio
Standard Deviation 0.12
|
0.25 ratio
Standard Deviation 0.12
|
0.24 ratio
Standard Deviation 0.12
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Flexion-follow up 1 month
|
0.26 ratio
Standard Deviation 0.16
|
0.26 ratio
Standard Deviation 0.11
|
0.25 ratio
Standard Deviation 0.10
|
0.25 ratio
Standard Deviation 0.13
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Flexion-follow up 3 months
|
0.27 ratio
Standard Deviation 0.16
|
0.25 ratio
Standard Deviation 0.11
|
0.23 ratio
Standard Deviation 0.15
|
0.23 ratio
Standard Deviation 0.11
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Extension-pre
|
0.29 ratio
Standard Deviation 0.16
|
0.31 ratio
Standard Deviation 0.23
|
0.25 ratio
Standard Deviation 0.15
|
0.23 ratio
Standard Deviation 0.18
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Extension-mid
|
0.25 ratio
Standard Deviation 0.12
|
0.28 ratio
Standard Deviation 0.20
|
0.26 ratio
Standard Deviation 0.15
|
0.22 ratio
Standard Deviation 0.18
|
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Co-contraction Ratio of Wrist Extension-follow up 3 months
|
0.28 ratio
Standard Deviation 0.18
|
0.27 ratio
Standard Deviation 0.18
|
0.27 ratio
Standard Deviation 0.15
|
0.22 ratio
Standard Deviation 0.14
|
Adverse Events
Bilateral TENS (Bi-TENS) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unilateral TENS (Uni-TENS) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Shamay Ng
Department of Rehabilitation Science, The Hong Kong Polytechnic University
Phone: 27664889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place