StrokeNCT03631628
Upper Limb Mirror Therapy With Bilateral Transcutaneous Electrical Nerve Stimulation to Improve Upper Limb Functions in Patients With Stroke
A study testing Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Mirror Therapy (MT) and Conventional Rehabilitation Program in people with Stroke, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial summary
This study compare the effectiveness of 2 rehabilitation programmes that use (1) MT with Bilateral TENS (Bi-TENS), (2) sham-MT with Bi-TENS (Bi-TENS), respectively, in addition to conventional rehabilitation of standardized upper limb training, in improving upper limb motor functions, activities of daily living… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Mirror Therapy (MT) and Conventional Rehabilitation Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have been diagnosed with ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography within three weeks to 10 years after the first onset of stroke;
- have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
- have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
- are able to score > 6 of 10 of abbreviated Mental Test;
- are able to follow instruction and give informed consent of the study.
Who cannot join
- Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
- Use cardiac pacemakers;
- Have receptive dysphasia;
- Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
- Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
- Have skin allergy that would prevent electrical stimulation;
- Are involved in drug studies or other clinical trials.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, Hong Kong
Shamay SM Ng, PhD, 27664889, Shamay.Ng@polyu.edu.hk
Shamay SM Ng, PhD
- Recruiting
Shatin Hospital
Hong Kong, Hong Kong
Shamay S M Ng, PhD, 27664889, Shamay.Ng@polyu.edu.hk
About this study
Official title: A Randomized Controlled Clinical Trial of Upper Limb Training With Mirror Therapy (MT) and Bilateral Transcutaneous Electrical Nerve Stimulation (Bi-TENS) to Improve Upper Limb Motor Functions in Patients With Stroke
This study compare the effectiveness of 2 rehabilitation programmes that use (1) MT with Bilateral TENS (Bi-TENS), (2) sham-MT with Bi-TENS (Bi-TENS), respectively, in addition to conventional rehabilitation of standardized upper limb training, in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.
Read the detailed description
The principal aim of the proposed study will be to demonstrate whether MT with Bi-TENS is more effective than sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration and quality of life in patients with stroke.
The null hypothesis will be that MT with Bi-TENS is not significantly different from sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.
- Conditions
- Stroke
- Being tested
- Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Mirror Therapy (MT), sham-Mirror Therapy (sham-MT), Conventional Rehabilitation Program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)Device
The stimulator is a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching, to provide sensory stimulation to both paretic and intact arms. Two pairs of disposable surface electrodes will be applied over the median nerve from the carpal tunnel to the flexor digitorum superficialis and the superficial radial nerve from the extensor pollicis longus to the extensor digitorum communis, with the cathode on the proximal site, and the anode on the distal site.
Mirror Therapy (MT)Behavioural
A customised angle-adjustable frame with a mirror board will be used. All subjects are instructed to perform
- Elbow flexion and extension exercise
- Forearm pronation and supination exercise
- Wrist flexion and extension exercise
- Wrist radial and ulnar deviation exercise
- Fingers opposition exercise
- Gripping exercise
The subject will complete bilaterally upper limb exercises during the 30 minutes period.
Intact arm will be placed in front of mirror, and paretic arm will be placed behind the mirror.
Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively.
Participants will be encouraged to focus on the image of intact arm when performing upper limb exercises bilaterally.
sham-Mirror Therapy (sham-MT)Behavioural
A customised angle-adjustable frame with a mirror board will be used while the reflecting surface of the mirror was covered with paper. All subjects are instructed to perform
- Elbow flexion and extension exercise
- Forearm pronation and supination exercise
- Wrist flexion and extension exercise
- Wrist radial and ulnar deviation exercise
- Fingers opposition exercise
- Gripping exercise
The subject will complete bilaterally upper limb exercises during the 30 minutes period.
Intact arm will be placed in front of covered mirror, and paretic arm will be placed behind the covered mirror.
Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively.
Conventional Rehabilitation ProgramBehavioural
Standardized upper limb training
| Study group | Role | What they receive |
|---|---|---|
| MT+ Bilateral TENS | Experimental | All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of MT+bilateral TENS and 1 hour conventional training of standardized upper limb training. Receives: Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: Mirror Therapy (MT); Behavioral: Conventional Rehabilitation Program |
| sham-MT+ Bilateral TENS | Placebo comparator | All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of sham-MT+bilateral TENS and 1 hour conventional training of standardized upper limb training. Receives: Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: sham-Mirror Therapy (sham-MT); Behavioral: Conventional Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Measured: Baseline (0 week)
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - midterm
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Measured: 4 weeks
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - post-training
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Measured: 8 weeks
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - followup
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Measured: 12 weeks
Wolf Motor Function Test (WMFT) - baseline
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Measured: Baseline (0 week)
Wolf Motor Function Test (WMFT) - midterm
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Measured: 4 weeks
Wolf Motor Function Test (WMFT) - post-training
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Measured: 8 weeks
Wolf Motor Function Test (WMFT) - followup
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Measured: 12 weeks
Secondary outcomes (28)
Grip Strength - baseline
Grip strength of both the paretic and intact hands will be measured using the Jamar dynamometer (Sammons Preston Rolyan, Bolingbrook, IL, USA) with standardized positioning and instructions recommended by the American Society of Hand Therapist. All subjects will be required to squeeze the dynamometer as hard as possible for 5 s for three trials. The force generated (in kilograms) in all three trials will be recorded and averaged for data analysis. The measurement of grip strength with the dynamometer has a high test-retest reliability (r=0.88-0.93) and inter-rater reliability (r=0.99).
Measured: Baseline (0 week)
Grip Strength - midterm
Grip strength of both the paretic and intact hands will be measured using the Jamar dynamometer (Sammons Preston Rolyan, Bolingbrook, IL, USA) with standardized positioning and instructions recommended by the American Society of Hand Therapist. All subjects will be required to squeeze the dynamometer as hard as possible for 5 s for three trials. The force generated (in kilograms) in all three trials will be recorded and averaged for data analysis. The measurement of grip strength with the dynamometer has a high test-retest reliability (r=0.88-0.93) and inter-rater reliability (r=0.99).
Measured: 4 weeks
Grip Strength - post-training
Grip strength of both the paretic and intact hands will be measured using the Jamar dynamometer (Sammons Preston Rolyan, Bolingbrook, IL, USA) with standardized positioning and instructions recommended by the American Society of Hand Therapist. All subjects will be required to squeeze the dynamometer as hard as possible for 5 s for three trials. The force generated (in kilograms) in all three trials will be recorded and averaged for data analysis. The measurement of grip strength with the dynamometer has a high test-retest reliability (r=0.88-0.93) and inter-rater reliability (r=0.99).
Measured: 8 weeks
Grip Strength - followup
Grip strength of both the paretic and intact hands will be measured using the Jamar dynamometer (Sammons Preston Rolyan, Bolingbrook, IL, USA) with standardized positioning and instructions recommended by the American Society of Hand Therapist. All subjects will be required to squeeze the dynamometer as hard as possible for 5 s for three trials. The force generated (in kilograms) in all three trials will be recorded and averaged for data analysis. The measurement of grip strength with the dynamometer has a high test-retest reliability (r=0.88-0.93) and inter-rater reliability (r=0.99).
Measured: 12 weeks
Jacket Test - baseline
The Jacket Test will be used to assess the stroke patients' upper limb proficiency in putting on and removing a long-sleeved jacket. The test will be performed in the standing position. The total time will be calculated by stopwatch as the sum of time to put on and take off clothes. The Jacket Test will be tested three times. Three trials of the Jacket Test time will be collected and averaged for data analysis. This test has excellent intra-rater, inter-rater and test-retest reliability (ICC = 0.781 - 1.000) in people with stroke.
Measured: Baseline (0 week)
Jacket Test - midterm
The Jacket Test will be used to assess the stroke patients' upper limb proficiency in putting on and removing a long-sleeved jacket. The test will be performed in the standing position. The total time will be calculated by stopwatch as the sum of time to put on and take off clothes. The Jacket Test will be tested three times. Three trials of the Jacket Test time will be collected and averaged for data analysis. This test has excellent intra-rater, inter-rater and test-retest reliability (ICC = 0.781 - 1.000) in people with stroke.
Measured: 4 weeks
Jacket Test - post-training
The Jacket Test will be used to assess the stroke patients' upper limb proficiency in putting on and removing a long-sleeved jacket. The test will be performed in the standing position. The total time will be calculated by stopwatch as the sum of time to put on and take off clothes. The Jacket Test will be tested three times. Three trials of the Jacket Test time will be collected and averaged for data analysis. This test has excellent intra-rater, inter-rater and test-retest reliability (ICC = 0.781 - 1.000) in people with stroke.
Measured: 8 weeks
Jacket Test - followup
The Jacket Test will be used to assess the stroke patients' upper limb proficiency in putting on and removing a long-sleeved jacket. The test will be performed in the standing position. The total time will be calculated by stopwatch as the sum of time to put on and take off clothes. The Jacket Test will be tested three times. Three trials of the Jacket Test time will be collected and averaged for data analysis. This test has excellent intra-rater, inter-rater and test-retest reliability (ICC = 0.781 - 1.000) in people with stroke.
Measured: 12 weeks
Upper Extremity Functional Index (UEFI) - baseline
The UEFI will be used to evaluate the upper extremity functional recovery among community-dwelling people with chronic stroke. UEFI contains 15 items with five patient-reported difficulty level (0 to 4), with a maximum score of 59. The UEFI has a good test-retest resliability (ICC = 0.87) and excellent internal consistency (Cronbach's α = 0.922) in people with chronic stroke. A higher score indicates a higher upper extremity functional recovery in people with chronic stroke.
Measured: Baseline (0 week)
Upper Extremity Functional Index (UEFI) - midterm
The UEFI will be used to evaluate the upper extremity functional recovery among community-dwelling people with chronic stroke. UEFI contains 15 items with five patient-reported difficulty level (0 to 4), with a maximum score of 59. The UEFI has a good test-retest resliability (ICC = 0.87) and excellent internal consistency (Cronbach's α = 0.922) in people with chronic stroke. A higher score indicates a higher upper extremity functional recovery in people with chronic stroke.
Measured: 4 weeks
Upper Extremity Functional Index (UEFI) - post-training
The UEFI will be used to evaluate the upper extremity functional recovery among community-dwelling people with chronic stroke. UEFI contains 15 items with five patient-reported difficulty level (0 to 4), with a maximum score of 59. The UEFI has a good test-retest resliability (ICC = 0.87) and excellent internal consistency (Cronbach's α = 0.922) in people with chronic stroke. A higher score indicates a higher upper extremity functional recovery in people with chronic stroke.
Measured: 8 weeks
Upper Extremity Functional Index (UEFI) - followup
The UEFI will be used to evaluate the upper extremity functional recovery among community-dwelling people with chronic stroke. UEFI contains 15 items with five patient-reported difficulty level (0 to 4), with a maximum score of 59. The UEFI has a good test-retest resliability (ICC = 0.87) and excellent internal consistency (Cronbach's α = 0.922) in people with chronic stroke. A higher score indicates a higher upper extremity functional recovery in people with chronic stroke.
Measured: 12 weeks
Motor Activity Log (MAL) - baseline
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. The AOU and QOM scores will be summed and averaged to yield a single MAL score for each subject. The MAL has high internal consistency (Cronbach alpha > 0.88), and reasonable construct validity (Spearman r=0.63) in patients with stroke, and the Chinese version of the MAL will be used in this study. A higher score indicates a better use of the affected hand in daily life.
Measured: Baseline (0 week)
Motor Activity Log (MAL) - midterm
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. The AOU and QOM scores will be summed and averaged to yield a single MAL score for each subject. The MAL has high internal consistency (Cronbach alpha > 0.88), and reasonable construct validity (Spearman r=0.63) in patients with stroke, and the Chinese version of the MAL will be used in this study. A higher score indicates a better use of the affected hand in daily life.
Measured: 4 weeks
Motor Activity Log (MAL) - post-training
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. The AOU and QOM scores will be summed and averaged to yield a single MAL score for each subject. The MAL has high internal consistency (Cronbach alpha > 0.88), and reasonable construct validity (Spearman r=0.63) in patients with stroke, and the Chinese version of the MAL will be used in this study. A higher score indicates a better use of the affected hand in daily life.
Measured: 8 weeks
- Motor Activity Log (MAL) - followup
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. The AOU and QOM scores will be summed and averaged to yield a single MAL score for each subject. The MAL has high internal consistency (Cronbach alpha > 0.88), and reasonable construct validity (Spearman r=0.63) in patients with stroke, and the Chinese version of the MAL will be used in this study. A higher score indicates a better use of the affected hand in daily life.
Measured: 12 weeks
Stroke Impact Scale (SIS) - baseline
SIS will be used to evaluate the health-related quality of life in stroke survivors. The SIS is a 59-item questionnaire which consists of 8 domains: Strength (4 items), memory and thinking (7 items), emotion (9 items), communication (7 items), ADL (10 items), mobility (9 items), hand function (5 items), and participation (8 items). Responses to each item will be based on a 5-point Likert scale that ask participants to score their level of difficulty with a task over the previous 2 weeks. Items from strength, ADL, mobility and hand function domains can be combined to create a composite physical functioning score. Scores for each domain are transformed into a score out of 100 using the formula: [(mean domain score-1)/(5-1)]*100. A higher score is indicative of better self-perceived health. The SIS has demonstrated validity and reliability for assessing health-related QoL.
Measured: Baseline (0 week)
Stroke Impact Scale (SIS) - midterm
SIS will be used to evaluate the health-related quality of life in stroke survivors. The SIS is a 59-item questionnaire which consists of 8 domains: Strength (4 items), memory and thinking (7 items), emotion (9 items), communication (7 items), ADL (10 items), mobility (9 items), hand function (5 items), and participation (8 items). Responses to each item will be based on a 5-point Likert scale that ask participants to score their level of difficulty with a task over the previous 2 weeks. Items from strength, ADL, mobility and hand function domains can be combined to create a composite physical functioning score. Scores for each domain are transformed into a score out of 100 using the formula: [(mean domain score-1)/(5-1)]*100. A higher score is indicative of better self-perceived health. The SIS has demonstrated validity and reliability for assessing health-related QoL.
Measured: 4 weeks
Stroke Impact Scale (SIS) - post-training
SIS will be used to evaluate the health-related quality of life in stroke survivors. The SIS is a 59-item questionnaire which consists of 8 domains: Strength (4 items), memory and thinking (7 items), emotion (9 items), communication (7 items), ADL (10 items), mobility (9 items), hand function (5 items), and participation (8 items). Responses to each item will be based on a 5-point Likert scale that ask participants to score their level of difficulty with a task over the previous 2 weeks. Items from strength, ADL, mobility and hand function domains can be combined to create a composite physical functioning score. Scores for each domain are transformed into a score out of 100 using the formula: [(mean domain score-1)/(5-1)]*100. A higher score is indicative of better self-perceived health. The SIS has demonstrated validity and reliability for assessing health-related QoL.
Measured: 8 weeks
Stroke Impact Scale (SIS) - followup
SIS will be used to evaluate the health-related quality of life in stroke survivors. The SIS is a 59-item questionnaire which consists of 8 domains: Strength (4 items), memory and thinking (7 items), emotion (9 items), communication (7 items), ADL (10 items), mobility (9 items), hand function (5 items), and participation (8 items). Responses to each item will be based on a 5-point Likert scale that ask participants to score their level of difficulty with a task over the previous 2 weeks. Items from strength, ADL, mobility and hand function domains can be combined to create a composite physical functioning score. Scores for each domain are transformed into a score out of 100 using the formula: [(mean domain score-1)/(5-1)]*100. A higher score is indicative of better self-perceived health. The SIS has demonstrated validity and reliability for assessing health-related QoL.
Measured: 12 weeks
Community Integration Questionnaire (CIM) - baseline
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item solicits a rating on a 5-point scale for a total score from 10 to 50. The CIM-C has demonstrated good internal consistency (Cronbach α, 0.84) and reliability (ICC, 0.84). A higher score indicates a higher level of community integration.
Measured: Baseline (0 week)
Community Integration Questionnaire (CIM) - midterm
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item solicits a rating on a 5-point scale for a total score from 10 to 50. The CIM-C has demonstrated good internal consistency (Cronbach α, 0.84) and reliability (ICC, 0.84). A higher score indicates a higher level of community integration.
Measured: 4 weeks
Community Integration Questionnaire (CIM) - post-training
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item solicits a rating on a 5-point scale for a total score from 10 to 50. The CIM-C has demonstrated good internal consistency (Cronbach α, 0.84) and reliability (ICC, 0.84). A higher score indicates a higher level of community integration.
Measured: 8 weeks
Community Integration Questionnaire (CIM) - followup
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item solicits a rating on a 5-point scale for a total score from 10 to 50. The CIM-C has demonstrated good internal consistency (Cronbach α, 0.84) and reliability (ICC, 0.84). A higher score indicates a higher level of community integration.
Measured: 12 weeks
SATIS-Stroke - baseline
The SATIS-Stroke will be used to evaluate the satisfaction with social participation among people with chronic stroke.The SATIS-Stroke contains 36 items using a four-point scale (0 to 3), with a maximum raw score of 108 (-5.11 to 5.08 in logits). The SATIS-Stroke has excellent internal consistency (Cronbach's α = 0.959) and good test-retest reliability (ICC = 0.91). A higher score indicates a high satisfaction level with social participation among people with chronic stroke.
Measured: Baseline (0 week)
SATIS-Stroke - midterm
The SATIS-Stroke will be used to evaluate the satisfaction with social participation among people with chronic stroke.The SATIS-Stroke contains 36 items using a four-point scale (0 to 3), with a maximum raw score of 108 (-5.11 to 5.08 in logits). The SATIS-Stroke has excellent internal consistency (Cronbach's α = 0.959) and good test-retest reliability (ICC = 0.91). A higher score indicates a high satisfaction level with social participation among people with chronic stroke.
Measured: 4 weeks
SATIS-Stroke- post-training
The SATIS-Stroke will be used to evaluate the satisfaction with social participation among people with chronic stroke.The SATIS-Stroke contains 36 items using a four-point scale (0 to 3), with a maximum raw score of 108 (-5.11 to 5.08 in logits). The SATIS-Stroke has excellent internal consistency (Cronbach's α = 0.959) and good test-retest reliability (ICC = 0.91). A higher score indicates a high satisfaction level with social participation among people with chronic stroke.
Measured: 8 weeks
SATIS-Stroke - followup
The SATIS-Stroke will be used to evaluate the satisfaction with social participation among people with chronic stroke.The SATIS-Stroke contains 36 items using a four-point scale (0 to 3), with a maximum raw score of 108 (-5.11 to 5.08 in logits). The SATIS-Stroke has excellent internal consistency (Cronbach's α = 0.959) and good test-retest reliability (ICC = 0.91). A higher score indicates a high satisfaction level with social participation among people with chronic stroke.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
- Investigators
- Shamay Ng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631628
- Sponsor's protocol ID
- 2019_MT_TENS_UL
- Status last verified
- Oct 2026
- First submitted
- 13 Aug 2018
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Upper Limb Training With Mirror Therapy (MT) and Bilateral Transcutaneous Electrical Nerve Stimulation (Bi-TENS) to Improve Upper Limb Motor Functions in Patients With Stroke
- ClinicalTrials.gov ID
- NCT03631628
- Acronym / sponsor ID
- 2019_MT_TENS_UL
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compare the effectiveness of 2 rehabilitation programmes that use (1) MT with Bilateral TENS (Bi-TENS), (2) sham-MT with Bi-TENS (Bi-TENS), respectively, in addition to conventional rehabilitation of standardized upper limb training, in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.
Detailed description
The principal aim of the proposed study will be to demonstrate whether MT with Bi-TENS is more effective than sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration and quality of life in patients with stroke.
The null hypothesis will be that MT with Bi-TENS is not significantly different from sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT+ Bilateral TENS | Experimental | Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Behavioral: Mirror Therapy (MT), Behavioral: Conventional Rehabilitation ProgramAll subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of MT+bilateral TENS and 1 hour conventional training of standardized upper limb training. |
| sham-MT+ Bilateral TENS | Placebo comparator | Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Behavioral: sham-Mirror Therapy (sham-MT), Behavioral: Conventional Rehabilitation ProgramAll subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of sham-MT+bilateral TENS and 1 hour conventional training of standardized upper limb training. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have been diagnosed with ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography within three weeks to 10 years after the first onset of stroke;
- have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
- have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
- are able to score > 6 of 10 of abbreviated Mental Test;
- are able to follow instruction and give informed consent of the study.
Key exclusion criteria (7 listed)
- Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
- Use cardiac pacemakers;
- Have receptive dysphasia;
- Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
- Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)The stimulator is a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching, to provide sensory stimulation to both paretic and intact arms. Two pairs of disposable surface electrodes will be applied over the median nerve from the carpal tunnel to the flexor digitorum superficialis and the superficial radial nerve from the extensor pollicis longus to the extensor digitorum communis, with the cathode on the proximal site, and the anode on the distal site. | Device | MT+ Bilateral TENS, sham-MT+ Bilateral TENS |
| Mirror Therapy (MT)A customised angle-adjustable frame with a mirror board will be used. All subjects are instructed to perform 1. Elbow flexion and extension exercise 2. Forearm pronation and supination exercise 3. Wrist flexion and extension exercise 4. Wrist radial and ulnar deviation exercise 5. Fingers opposition exercise 6. Gripping exercise The subject will complete bilaterally upper limb exercises during the 30 minutes period. Intact arm will be placed in front of mirror, and paretic arm will be placed behind the mirror. Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively. Participants will be encouraged to focus on the image of intact arm when performing upper limb exercises bilaterally. | Behavioural | MT+ Bilateral TENS |
| sham-Mirror Therapy (sham-MT)A customised angle-adjustable frame with a mirror board will be used while the reflecting surface of the mirror was covered with paper. All subjects are instructed to perform 1. Elbow flexion and extension exercise 2. Forearm pronation and supination exercise 3. Wrist flexion and extension exercise 4. Wrist radial and ulnar deviation exercise 5. Fingers opposition exercise 6. Gripping exercise The subject will complete bilaterally upper limb exercises during the 30 minutes period. Intact arm will be placed in front of covered mirror, and paretic arm will be placed behind the covered mirror. Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively. | Behavioural | sham-MT+ Bilateral TENS |
| Conventional Rehabilitation ProgramStandardized upper limb training | Behavioural | MT+ Bilateral TENS, sham-MT+ Bilateral TENS |
Primary outcome
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline
Time frame: Baseline (0 week)
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - midterm
Time frame: 4 weeks
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - post-training
Time frame: 8 weeks
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - followup
Time frame: 12 weeks
The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.
Wolf Motor Function Test (WMFT) - baseline
Time frame: Baseline (0 week)
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Wolf Motor Function Test (WMFT) - midterm
Time frame: 4 weeks
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Wolf Motor Function Test (WMFT) - post-training
Time frame: 8 weeks
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
Wolf Motor Function Test (WMFT) - followup
Time frame: 12 weeks
Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.
28 secondary outcomes
Grip Strength - baseline
Time frame: Baseline (0 week)
Grip Strength - midterm
Time frame: 4 weeks
Grip Strength - post-training
Time frame: 8 weeks
Grip Strength - followup
Time frame: 12 weeks
Jacket Test - baseline
Time frame: Baseline (0 week)
Jacket Test - midterm
Time frame: 4 weeks
Jacket Test - post-training
Time frame: 8 weeks
Jacket Test - followup
Time frame: 12 weeks
Upper Extremity Functional Index (UEFI) - baseline
Time frame: Baseline (0 week)
Upper Extremity Functional Index (UEFI) - midterm
Time frame: 4 weeks
Upper Extremity Functional Index (UEFI) - post-training
Time frame: 8 weeks
Upper Extremity Functional Index (UEFI) - followup
Time frame: 12 weeks
Motor Activity Log (MAL) - baseline
Time frame: Baseline (0 week)
Motor Activity Log (MAL) - midterm
Time frame: 4 weeks
Motor Activity Log (MAL) - post-training
Time frame: 8 weeks
- Motor Activity Log (MAL) - followup
Time frame: 12 weeks
Stroke Impact Scale (SIS) - baseline
Time frame: Baseline (0 week)
Stroke Impact Scale (SIS) - midterm
Time frame: 4 weeks
Stroke Impact Scale (SIS) - post-training
Time frame: 8 weeks
Stroke Impact Scale (SIS) - followup
Time frame: 12 weeks
Community Integration Questionnaire (CIM) - baseline
Time frame: Baseline (0 week)
Community Integration Questionnaire (CIM) - midterm
Time frame: 4 weeks
Community Integration Questionnaire (CIM) - post-training
Time frame: 8 weeks
Community Integration Questionnaire (CIM) - followup
Time frame: 12 weeks
SATIS-Stroke - baseline
Time frame: Baseline (0 week)
SATIS-Stroke - midterm
Time frame: 4 weeks
SATIS-Stroke- post-training
Time frame: 8 weeks
SATIS-Stroke - followup
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shamay Ng, PhD principal investigator
The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS), Mirror Therapy (MT) and Conventional Rehabilitation Program in people with Stroke, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shamay NG, PhD (+852 2766-4889, shamay.ng@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline (time frame: Baseline (0 week)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.