Stroke
Conditions
Keywords
upper limb, transcutaneous electrical nerve stimulation
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.
Interventions
BEHAVIORALTask-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.
DEVICETranscutaneous 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
DEVICESham electrical nerve stimulation
A identical-looking TENS devices that electrical circuit has been disconnected.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant and outcome assessor were blinded to the group allocation
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilateral TENS (Bi-TENS) Group 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 | 30 |
| Unilateral TENS (Uni-TENS) Group 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 | 30 |
| Placebo Group 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 | 30 |
| Control Group No Active intervention | 30 |
| Total | 120 |
Baseline characteristics
| Characteristic | Bilateral TENS (Bi-TENS) Group | Unilateral TENS (Uni-TENS) Group | Placebo Group | Control Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 7 Participants | 8 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 21 Participants | 23 Participants | 22 Participants | 89 Participants |
| Age, Continuous | 60.37 years STANDARD_DEVIATION 7.13 | 62.30 years STANDARD_DEVIATION 7.3 | 61.70 years STANDARD_DEVIATION 6.7 | 61.70 years STANDARD_DEVIATION 5.91 | 61.52 years STANDARD_DEVIATION 6.73 |
| Fugl-Meyer Assessment of Upper Extremity | 37.03 units on a scale STANDARD_DEVIATION 12.02 | 41.83 units on a scale STANDARD_DEVIATION 17.12 | 38.77 units on a scale STANDARD_DEVIATION 15.78 | 43.93 units on a scale STANDARD_DEVIATION 18.74 | 40.39 units on a scale STANDARD_DEVIATION 16.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 120 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Hong Kong | 30 participants | 30 participants | 30 participants | 30 participants | 120 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 9 Participants | 10 Participants | 44 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 21 Participants | 20 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Pre-intervention | 37.03 score on a scale | Standard Deviation 12.02 |
| Bilateral TENS (Bi-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 3-month followed up | 43.17 score on a scale | Standard Deviation 13.61 |
| Bilateral TENS (Bi-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Post-intervention | 43.43 score on a scale | Standard Deviation 13.73 |
| Bilateral TENS (Bi-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Mid-intervention | 41.27 score on a scale | Standard Deviation 13.38 |
| Bilateral TENS (Bi-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 1-month followed up | 42.60 score on a scale | Standard Deviation 13.36 |
| Unilateral TENS (Uni-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 3-month followed up | 43.17 score on a scale | Standard Deviation 18.65 |
| Unilateral TENS (Uni-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Post-intervention | 44.23 score on a scale | Standard Deviation 16.12 |
| Unilateral TENS (Uni-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Pre-intervention | 41.83 score on a scale | Standard Deviation 17.12 |
| Unilateral TENS (Uni-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 1-month followed up | 42.70 score on a scale | Standard Deviation 17.35 |
| Unilateral TENS (Uni-TENS) Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Mid-intervention | 43.60 score on a scale | Standard Deviation 17.21 |
| Placebo Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Pre-intervention | 38.77 score on a scale | Standard Deviation 15.78 |
| Placebo Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Post-intervention | 40.23 score on a scale | Standard Deviation 14.97 |
| Placebo Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Mid-intervention | 40.13 score on a scale | Standard Deviation 15.41 |
| Placebo Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 1-month followed up | 40.90 score on a scale | Standard Deviation 14.43 |
| Placebo Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 3-month followed up | 40.60 score on a scale | Standard Deviation 14.67 |
| Control Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 3-month followed up | 45.23 score on a scale | Standard Deviation 17.77 |
| Control Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | 1-month followed up | 45.03 score on a scale | Standard Deviation 17.99 |
| Control Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Pre-intervention | 43.93 score on a scale | Standard Deviation 18.74 |
| Control Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Post-intervention | 44.20 score on a scale | Standard Deviation 18.16 |
| Control Group | Fugl Meyer Assessment on Upper Extremity (FMA-UE) | Mid-intervention | 44.87 score on a scale | Standard Deviation 17.25 |
Secondary
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.
Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | Action Research Arm Test (ARAT) | Post-intervention | 33.40 score on a scale | Standard Deviation 19.77 |
| Bilateral TENS (Bi-TENS) Group | Action Research Arm Test (ARAT) | Mid-intervention | 31.27 score on a scale | Standard Deviation 20.86 |
| Bilateral TENS (Bi-TENS) Group | Action Research Arm Test (ARAT) | 1-month followed-up | 31.33 score on a scale | Standard Deviation 19.24 |
| Bilateral TENS (Bi-TENS) Group | Action Research Arm Test (ARAT) | 3-month followed-up | 32.20 score on a scale | Standard Deviation 20.12 |
| Bilateral TENS (Bi-TENS) Group | Action Research Arm Test (ARAT) | Pre-intervention | 28.70 score on a scale | Standard Deviation 20.09 |
| Unilateral TENS (Uni-TENS) Group | Action Research Arm Test (ARAT) | Pre-intervention | 31.73 score on a scale | Standard Deviation 20.09 |
| Unilateral TENS (Uni-TENS) Group | Action Research Arm Test (ARAT) | 3-month followed-up | 33.33 score on a scale | Standard Deviation 21.17 |
| Unilateral TENS (Uni-TENS) Group | Action Research Arm Test (ARAT) | Post-intervention | 33.13 score on a scale | Standard Deviation 20.8 |
| Unilateral TENS (Uni-TENS) Group | Action Research Arm Test (ARAT) | 1-month followed-up | 34.90 score on a scale | Standard Deviation 19.74 |
| Unilateral TENS (Uni-TENS) Group | Action Research Arm Test (ARAT) | Mid-intervention | 33.93 score on a scale | Standard Deviation 20.27 |
| Placebo Group | Action Research Arm Test (ARAT) | 3-month followed-up | 30.43 score on a scale | Standard Deviation 21.97 |
| Placebo Group | Action Research Arm Test (ARAT) | Mid-intervention | 29.40 score on a scale | Standard Deviation 20.85 |
| Placebo Group | Action Research Arm Test (ARAT) | Post-intervention | 30.30 score on a scale | Standard Deviation 21.65 |
| Placebo Group | Action Research Arm Test (ARAT) | 1-month followed-up | 31.03 score on a scale | Standard Deviation 21.83 |
| Placebo Group | Action Research Arm Test (ARAT) | Pre-intervention | 28.30 score on a scale | Standard Deviation 21.69 |
| Control Group | Action Research Arm Test (ARAT) | Mid-intervention | 35.30 score on a scale | Standard Deviation 21.61 |
| Control Group | Action Research Arm Test (ARAT) | Pre-intervention | 34.97 score on a scale | Standard Deviation 21.97 |
| Control Group | Action Research Arm Test (ARAT) | Post-intervention | 36.07 score on a scale | Standard Deviation 22.85 |
| Control Group | Action Research Arm Test (ARAT) | 3-month followed-up | 36.27 score on a scale | Standard Deviation 22.29 |
| Control Group | Action Research Arm Test (ARAT) | 1-month followed-up | 36.77 score on a scale | Standard Deviation 21.79 |
Secondary
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.
Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | Chinese Version of Community Integration Measure (CIM) | Post-intervention | 40.17 score on a scale | Standard Deviation 7.04 |
| Bilateral TENS (Bi-TENS) Group | Chinese Version of Community Integration Measure (CIM) | Mid-intervention | 41.23 score on a scale | Standard Deviation 6.6 |
| Bilateral TENS (Bi-TENS) Group | Chinese Version of Community Integration Measure (CIM) | 1-month followed-up | 41.63 score on a scale | Standard Deviation 6.96 |
| Bilateral TENS (Bi-TENS) Group | Chinese Version of Community Integration Measure (CIM) | 3-month followed-up | 40.10 score on a scale | Standard Deviation 7.16 |
| Bilateral TENS (Bi-TENS) Group | Chinese Version of Community Integration Measure (CIM) | Pre-intervention | 39.47 score on a scale | Standard Deviation 7.51 |
| Unilateral TENS (Uni-TENS) Group | Chinese Version of Community Integration Measure (CIM) | 1-month followed-up | 42.70 score on a scale | Standard Deviation 12.92 |
| Unilateral TENS (Uni-TENS) Group | Chinese Version of Community Integration Measure (CIM) | Pre-intervention | 41.23 score on a scale | Standard Deviation 6.89 |
| Unilateral TENS (Uni-TENS) Group | Chinese Version of Community Integration Measure (CIM) | Post-intervention | 41.67 score on a scale | Standard Deviation 9.66 |
| Unilateral TENS (Uni-TENS) Group | Chinese Version of Community Integration Measure (CIM) | 3-month followed-up | 40.23 score on a scale | Standard Deviation 10.45 |
| Unilateral TENS (Uni-TENS) Group | Chinese Version of Community Integration Measure (CIM) | Mid-intervention | 39.90 score on a scale | Standard Deviation 11.79 |
| Placebo Group | Chinese Version of Community Integration Measure (CIM) | Post-intervention | 42.17 score on a scale | Standard Deviation 8.33 |
| Placebo Group | Chinese Version of Community Integration Measure (CIM) | 1-month followed-up | 43.17 score on a scale | Standard Deviation 7 |
| Placebo Group | Chinese Version of Community Integration Measure (CIM) | Mid-intervention | 42.20 score on a scale | Standard Deviation 7.4 |
| Placebo Group | Chinese Version of Community Integration Measure (CIM) | 3-month followed-up | 41.03 score on a scale | Standard Deviation 7.93 |
| Placebo Group | Chinese Version of Community Integration Measure (CIM) | Pre-intervention | 41.87 score on a scale | Standard Deviation 8.02 |
| Control Group | Chinese Version of Community Integration Measure (CIM) | Post-intervention | 39.80 score on a scale | Standard Deviation 9.31 |
| Control Group | Chinese Version of Community Integration Measure (CIM) | 3-month followed-up | 41.10 score on a scale | Standard Deviation 8.86 |
| Control Group | Chinese Version of Community Integration Measure (CIM) | 1-month followed-up | 39.33 score on a scale | Standard Deviation 9.08 |
| Control Group | Chinese Version of Community Integration Measure (CIM) | Pre-intervention | 39.67 score on a scale | Standard Deviation 9.21 |
| Control Group | Chinese Version of Community Integration Measure (CIM) | Mid-intervention | 38.37 score on a scale | Standard Deviation 9.04 |
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | Jacket Test (JT) | 1-month followed-up | 33.35 second | Standard Deviation 12.46 |
| Bilateral TENS (Bi-TENS) Group | Jacket Test (JT) | Post-intervention | 32.55 second | Standard Deviation 11.7 |
| Bilateral TENS (Bi-TENS) Group | Jacket Test (JT) | Pre-intervention | 36.51 second | Standard Deviation 12.44 |
| Bilateral TENS (Bi-TENS) Group | Jacket Test (JT) | 3-month followed-up | 32.00 second | Standard Deviation 12.51 |
| Bilateral TENS (Bi-TENS) Group | Jacket Test (JT) | Mid-intervention | 33.02 second | Standard Deviation 13.66 |
| Unilateral TENS (Uni-TENS) Group | Jacket Test (JT) | Mid-intervention | 35.78 second | Standard Deviation 20.92 |
| Unilateral TENS (Uni-TENS) Group | Jacket Test (JT) | Pre-intervention | 36.98 second | Standard Deviation 22.02 |
| Unilateral TENS (Uni-TENS) Group | Jacket Test (JT) | Post-intervention | 30.67 second | Standard Deviation 15.66 |
| Unilateral TENS (Uni-TENS) Group | Jacket Test (JT) | 3-month followed-up | 32.54 second | Standard Deviation 18.11 |
| Unilateral TENS (Uni-TENS) Group | Jacket Test (JT) | 1-month followed-up | 32.83 second | Standard Deviation 20.32 |
| Placebo Group | Jacket Test (JT) | Post-intervention | 34.71 second | Standard Deviation 16.08 |
| Placebo Group | Jacket Test (JT) | 1-month followed-up | 34.24 second | Standard Deviation 18.25 |
| Placebo Group | Jacket Test (JT) | 3-month followed-up | 34.24 second | Standard Deviation 17.19 |
| Placebo Group | Jacket Test (JT) | Pre-intervention | 36.87 second | Standard Deviation 17.53 |
| Placebo Group | Jacket Test (JT) | Mid-intervention | 36.86 second | Standard Deviation 15.53 |
| Control Group | Jacket Test (JT) | Post-intervention | 34.08 second | Standard Deviation 23.55 |
| Control Group | Jacket Test (JT) | 3-month followed-up | 31.77 second | Standard Deviation 22.19 |
| Control Group | Jacket Test (JT) | Pre-intervention | 33.36 second | Standard Deviation 21.39 |
| Control Group | Jacket Test (JT) | Mid-intervention | 32.58 second | Standard Deviation 23.41 |
| Control Group | Jacket Test (JT) | 1-month followed-up | 31.47 second | Standard Deviation 21.79 |
Secondary
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.
Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 1 month | 0.26 ratio | Standard Deviation 0.16 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-mid | 0.26 ratio | Standard Deviation 0.13 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-pre | 0.29 ratio | Standard Deviation 0.16 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 3 months | 0.27 ratio | Standard Deviation 0.16 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 3 months | 0.28 ratio | Standard Deviation 0.18 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-post | 0.27 ratio | Standard Deviation 0.14 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-post | 0.26 ratio | Standard Deviation 0.14 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 1 month | 0.29 ratio | Standard Deviation 0.17 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-pre | 0.28 ratio | Standard Deviation 0.14 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-mid | 0.25 ratio | Standard Deviation 0.12 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-mid | 0.28 ratio | Standard Deviation 0.2 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-mid | 0.27 ratio | Standard Deviation 0.13 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-post | 0.28 ratio | Standard Deviation 0.12 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 1 month | 0.26 ratio | Standard Deviation 0.11 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-pre | 0.31 ratio | Standard Deviation 0.23 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-post | 0.28 ratio | Standard Deviation 0.21 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 1 month | 0.28 ratio | Standard Deviation 0.23 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-pre | 0.24 ratio | Standard Deviation 0.11 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 3 months | 0.25 ratio | Standard Deviation 0.11 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 3 months | 0.27 ratio | Standard Deviation 0.18 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-mid | 0.23 ratio | Standard Deviation 0.11 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-mid | 0.26 ratio | Standard Deviation 0.15 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 1 month | 0.25 ratio | Standard Deviation 0.1 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 1 month | 0.26 ratio | Standard Deviation 0.14 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 3 months | 0.23 ratio | Standard Deviation 0.15 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-post | 0.28 ratio | Standard Deviation 0.16 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-pre | 0.25 ratio | Standard Deviation 0.15 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-pre | 0.25 ratio | Standard Deviation 0.15 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 3 months | 0.27 ratio | Standard Deviation 0.15 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-post | 0.25 ratio | Standard Deviation 0.12 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-post | 0.24 ratio | Standard Deviation 0.12 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-pre | 0.24 ratio | Standard Deviation 0.13 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-mid | 0.22 ratio | Standard Deviation 0.18 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 1 month | 0.23 ratio | Standard Deviation 0.15 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-post | 0.27 ratio | Standard Deviation 0.2 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-mid | 0.24 ratio | Standard Deviation 0.13 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-follow up 3 months | 0.22 ratio | Standard Deviation 0.14 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 1 month | 0.25 ratio | Standard Deviation 0.13 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Flexion-follow up 3 months | 0.23 ratio | Standard Deviation 0.11 |
| Control Group | Maximal Voluntary Contraction (MVC)-Cocontraction Ratio | Co-contraction Ratio of Wrist Extension-pre | 0.23 ratio | Standard Deviation 0.18 |
Secondary
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.
Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 1-month followed up | 3.87 N*m | Standard Deviation 1.89 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Pre-intervention | 3.69 N*m | Standard Deviation 1.79 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Post-intervention | 5.10 N*m | Standard Deviation 2.17 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 3-month followed up | 5.08 N*m | Standard Deviation 2.12 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 1-month followed up | 4.86 N*m | Standard Deviation 2.3 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 3-month followed | 3.91 N*m | Standard Deviation 1.98 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Mid-intervention | 4.40 N*m | Standard Deviation 1.9 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Pre-intervention | 3.38 N*m | Standard Deviation 1.95 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Mid-intervention | 3.62 N*m | Standard Deviation 1.7 |
| Bilateral TENS (Bi-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Post-intervention | 3.77 N*m | Standard Deviation 1.7 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Mid-intervention | 3.10 N*m | Standard Deviation 2.46 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Post-intervention | 3.58 N*m | Standard Deviation 2.74 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Mid-intervention | 4.77 N*m | Standard Deviation 2.74 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 1-month followed up | 3.67 N*m | Standard Deviation 2.82 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Post-intervention | 4.74 N*m | Standard Deviation 2.43 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 3-month followed up | 4.89 N*m | Standard Deviation 2.5 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 3-month followed | 3.86 N*m | Standard Deviation 2.76 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Pre-intervention | 3.12 N*m | Standard Deviation 2.36 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 1-month followed up | 4.85 N*m | Standard Deviation 2.6 |
| Unilateral TENS (Uni-TENS) Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Pre-intervention | 4.51 N*m | Standard Deviation 2.63 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 3-month followed | 3.66 N*m | Standard Deviation 2.86 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Pre-intervention | 4.86 N*m | Standard Deviation 2.82 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 1-month followed up | 5.17 N*m | Standard Deviation 2.84 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 3-month followed up | 5.28 N*m | Standard Deviation 2.62 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Post-intervention | 3.81 N*m | Standard Deviation 2.62 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Mid-intervention | 4.71 N*m | Standard Deviation 2.74 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Post-intervention | 4.94 N*m | Standard Deviation 2.58 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Pre-intervention | 3.40 N*m | Standard Deviation 2.17 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Mid-intervention | 3.41 N*m | Standard Deviation 2.48 |
| Placebo Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 1-month followed up | 3.61 N*m | Standard Deviation 2.35 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 3-month followed | 3.98 N*m | Standard Deviation 2.67 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Mid-intervention | 5.35 N*m | Standard Deviation 2.68 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Mid-intervention | 3.55 N*m | Standard Deviation 2.53 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Post-intervention | 3.71 N*m | Standard Deviation 2.39 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 3-month followed up | 5.70 N*m | Standard Deviation 2.78 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Pre-intervention | 5.13 N*m | Standard Deviation 2.29 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension- 1-month followed up | 3.81 N*m | Standard Deviation 2.34 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion-Post-intervention | 5.39 N*m | Standard Deviation 2.64 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist flexion- 1-month followed up | 5.57 N*m | Standard Deviation 2.72 |
| Control Group | Maximal Voluntary Contraction (MVC)-Peak Torque | Peak Torque-wrist extension-Pre-intervention | 3.64 N*m | Standard Deviation 2.64 |
Secondary
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.
Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | AOU-1-month followed-up | 35.95 score on a scale | Standard Deviation 31.91 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | AOU-Mid | 35.57 score on a scale | Standard Deviation 35.59 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | QOM-Pre | 42.10 score on a scale | Standard Deviation 36.15 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | AOU-3-month followed-up | 39.80 score on a scale | Standard Deviation 34.42 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | QOM-Mid | 41.83 score on a scale | Standard Deviation 37.57 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | QOM-1-month followed-up | 43.05 score on a scale | Standard Deviation 35.85 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | AOU-Post | 38.53 score on a scale | Standard Deviation 38.86 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | QOM-3-month followed-up | 43.28 score on a scale | Standard Deviation 39.07 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | AOU-Pre | 34.03 score on a scale | Standard Deviation 30.35 |
| Bilateral TENS (Bi-TENS) Group | Motor Activity Log (MAL) | QOM-Post | 40.93 score on a scale | Standard Deviation 35.97 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | QOM-Post | 61.38 score on a scale | Standard Deviation 53.73 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | AOU-Mid | 44.93 score on a scale | Standard Deviation 47.92 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | AOU-Post | 48.87 score on a scale | Standard Deviation 49.56 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | AOU-1-month followed-up | 48.68 score on a scale | Standard Deviation 49.49 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | AOU-3-month followed-up | 58.03 score on a scale | Standard Deviation 54.14 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | QOM-1-month followed-up | 54.00 score on a scale | Standard Deviation 51.32 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | QOM-3-month followed-up | 59.08 score on a scale | Standard Deviation 54.2 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | AOU-Pre | 49.72 score on a scale | Standard Deviation 47.73 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | QOM-Pre | 56.92 score on a scale | Standard Deviation 49.89 |
| Unilateral TENS (Uni-TENS) Group | Motor Activity Log (MAL) | QOM-Mid | 53.20 score on a scale | Standard Deviation 47.32 |
| Placebo Group | Motor Activity Log (MAL) | QOM-3-month followed-up | 54.23 score on a scale | Standard Deviation 50.13 |
| Placebo Group | Motor Activity Log (MAL) | QOM-1-month followed-up | 54.88 score on a scale | Standard Deviation 53.83 |
| Placebo Group | Motor Activity Log (MAL) | QOM-Pre | 52.42 score on a scale | Standard Deviation 45.09 |
| Placebo Group | Motor Activity Log (MAL) | QOM-Post | 51.53 score on a scale | Standard Deviation 46.76 |
| Placebo Group | Motor Activity Log (MAL) | AOU-Pre | 39.20 score on a scale | Standard Deviation 40.54 |
| Placebo Group | Motor Activity Log (MAL) | AOU-3-month followed-up | 50.53 score on a scale | Standard Deviation 48.84 |
| Placebo Group | Motor Activity Log (MAL) | AOU-Mid | 53.27 score on a scale | Standard Deviation 50.99 |
| Placebo Group | Motor Activity Log (MAL) | AOU-1-month followed-up | 48.58 score on a scale | Standard Deviation 50.04 |
| Placebo Group | Motor Activity Log (MAL) | QOM-Mid | 61.10 score on a scale | Standard Deviation 53.46 |
| Placebo Group | Motor Activity Log (MAL) | AOU-Post | 54.70 score on a scale | Standard Deviation 50.15 |
| Control Group | Motor Activity Log (MAL) | AOU-Post | 45.10 score on a scale | Standard Deviation 44.62 |
| Control Group | Motor Activity Log (MAL) | AOU-Mid | 47.73 score on a scale | Standard Deviation 43.91 |
| Control Group | Motor Activity Log (MAL) | QOM-3-month followed-up | 57.18 score on a scale | Standard Deviation 50.78 |
| Control Group | Motor Activity Log (MAL) | QOM-1-month followed-up | 57.13 score on a scale | Standard Deviation 53.52 |
| Control Group | Motor Activity Log (MAL) | AOU-Pre | 45.28 score on a scale | Standard Deviation 34.5 |
| Control Group | Motor Activity Log (MAL) | QOM-Mid | 51.53 score on a scale | Standard Deviation 46.79 |
| Control Group | Motor Activity Log (MAL) | QOM-Post | 52.77 score on a scale | Standard Deviation 44.83 |
| Control Group | Motor Activity Log (MAL) | AOU-1-month followed-up | 49.25 score on a scale | Standard Deviation 50.86 |
| Control Group | Motor Activity Log (MAL) | QOM-Pre | 58.00 score on a scale | Standard Deviation 43.44 |
| Control Group | Motor Activity Log (MAL) | AOU-3-month followed-up | 46.42 score on a scale | Standard Deviation 46.33 |
Secondary
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.
Time frame: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-3-month followed-up | 85.13 degree | Standard Deviation 33.79 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Post | 87.70 degree | Standard Deviation 23.78 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-3-month followed-up | 70.67 degree | Standard Deviation 39.57 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Pre | 72.42 degree | Standard Deviation 40.84 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Mid | 84.70 degree | Standard Deviation 22.96 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Post | 73.83 degree | Standard Deviation 35.51 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-1-month followed-up | 72.92 degree | Standard Deviation 37.84 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Pre | 76.67 degree | Standard Deviation 28.89 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Mid | 71.43 degree | Standard Deviation 36.45 |
| Bilateral TENS (Bi-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-1-month followed-up | 84.13 degree | Standard Deviation 30.91 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Post | 88.47 degree | Standard Deviation 26.07 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-3-month followed-up | 89.90 degree | Standard Deviation 30.74 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Post | 75.42 degree | Standard Deviation 47.96 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Mid | 74.77 degree | Standard Deviation 47.35 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Pre | 69.97 degree | Standard Deviation 49.52 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-3-month followed-up | 78.32 degree | Standard Deviation 54.34 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Pre | 85.73 degree | Standard Deviation 27.3 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-1-month followed-up | 84.05 degree | Standard Deviation 29.51 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-1-month followed-up | 78.30 degree | Standard Deviation 48.23 |
| Unilateral TENS (Uni-TENS) Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Mid | 84.33 degree | Standard Deviation 28.58 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-1-month followed-up | 66.05 degree | Standard Deviation 38.46 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Mid | 86.75 degree | Standard Deviation 22.64 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Post | 83.60 degree | Standard Deviation 18.82 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-3-month followed-up | 71.18 degree | Standard Deviation 44.39 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-1-month followed-up | 81.85 degree | Standard Deviation 23.81 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-3-month followed-up | 81.95 degree | Standard Deviation 20.1 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Mid | 62.23 degree | Standard Deviation 50.02 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Pre | 72.70 degree | Standard Deviation 44.04 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Post | 69.77 degree | Standard Deviation 42.35 |
| Placebo Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Pre | 82.88 degree | Standard Deviation 24.01 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Pre | 90.22 degree | Standard Deviation 33.36 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-1-month followed-up | 89.67 degree | Standard Deviation 26.64 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Mid | 87.72 degree | Standard Deviation 40.34 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-3-month followed-up | 90.78 degree | Standard Deviation 45.25 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-3-month followed-up | 87.02 degree | Standard Deviation 27.53 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Mid | 79.28 degree | Standard Deviation 29.33 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Post | 90.07 degree | Standard Deviation 42.02 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Elbow-Post | 86.75 degree | Standard Deviation 23.06 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-1-month followed-up | 87.97 degree | Standard Deviation 46.11 |
| Control Group | The Range of Motion (ROM) of Upper Limb Joints | Wrist-Pre | 87.41 degree | Standard Deviation 48.28 |