Upper Limb Mirror Therapy With TENS to Improve Upper Limb Functions in Patients With Sub-acute Stroke
Study Details
Study Description
Brief Summary
This study compare the effectiveness of 2 rehabilitation programmes that use (1) MT with TENS, (2) sham-MT with TENS, respectively, in addition to standardized upper limb training (TOT), in improving upper limb motor functions, activities of daily living, community integration and quality of life in patients with sub-acute stroke.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MT+TENS All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program per visit to the Rehabilitation Clinic: 30 minutes of TENS + MT and 1 hour conventional training. |
Device: Transcutaneous electrical nerve stimulation (TENS)
TENS will be delivered to the median and radial nerves at the wrist regions. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.
Behavioral: Mirror Therapy (MT)
A customised angle-adjustable frame with a mirror board will be used. All subjects are instructed to perform
Wrist flexion and extension exercise
Forearm pronation and supination exercise
Gripping exercises
Fingers opposition exercises bilaterally during the 30 minutes period.
Behavioral: Conventional Rehabilitation Program
All subjects attended 1 hour multi-disciplinary conventional rehabilitation program offered by the Rehabilitation Clinic of The Hong Kong Polytechnic University. The conventional rehabilitation program involves the training of upper and lower limbs in order to improve the muscle strength, balance and functional mobility.
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| Placebo Comparator: sham-MT+TENS All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program per visit to the Rehabilitation Clinic: 30 minutes of TENS + sham-MT and 1-hour conventional training. |
Device: Transcutaneous electrical nerve stimulation (TENS)
TENS will be delivered to the median and radial nerves at the wrist regions. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.
Behavioral: 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
Wrist flexion and extension exercise
Forearm pronation and supination exercise
Gripping exercises
Fingers opposition exercises bilaterally during the 30 minutes period.
Behavioral: Conventional Rehabilitation Program
All subjects attended 1 hour multi-disciplinary conventional rehabilitation program offered by the Rehabilitation Clinic of The Hong Kong Polytechnic University. The conventional rehabilitation program involves the training of upper and lower limbs in order to improve the muscle strength, balance and functional mobility.
|
Outcome Measures
Primary Outcome Measures
- Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline [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 [3 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 [6 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 [10 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 [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 [3 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 [6 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 [10 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.
Secondary Outcome Measures
- Stroke Impact Scale (SIS) - baseline [Baseline (0 week)]
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.
- Stroke Impact Scale (SIS) - midterm [3 weeks]
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.
- Stroke Impact Scale (SIS) - post-training [6 weeks]
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.
- Stroke Impact Scale (SIS) - followup [10 weeks]
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.
- Grip Strength - baseline [Baseline (0 week)]
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).
- Grip Strength - midterm [3 weeks]
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).
- Grip Strength - post-training [6 weeks]
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).
- Grip Strength - followup [10 weeks]
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).
- Motor Activity Log (MAL) - baseline [Baseline (0 week)]
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.
- Motor Activity Log (MAL) - midterm [3 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. 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.
- Motor Activity Log (MAL) - post-training [6 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. 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.
- Motor Activity Log (MAL) - followup [10 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. 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.
- Community Integration Questionnaire (CIM) - baseline [Baseline (0 week)]
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.
- Community Integration Questionnaire (CIM) - midterm [3 weeks]
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.
- Community Integration Questionnaire (CIM) - post-training [6 weeks]
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.
- Community Integration Questionnaire (CIM) - followup [10 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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have been diagnosed with ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography within 3 to 11 weeks after the onset of current stroke;
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have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
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have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
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are able to score > 6 of 10 of abbreviated Mental Test;
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are able to follow instruction and give informed consent of the study.
Exclusion Criteria:
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Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
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Use cardiac pacemakers;
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Have receptive dysphasia;
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Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
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Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
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Have skin allergy that would prevent electrical stimulation;
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Are involved in drug studies or other clinical trials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Hong Kong Polytechnic University | Hong Kong | Hong Kong | Hong Kong |
Sponsors and Collaborators
- The Hong Kong Polytechnic University
Investigators
- Principal Investigator: Shamay Ng, PhD, The Hong Kong Polytechnic University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019_MT_TENS_UL