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Upper Limb Mirror Therapy With TENS to Improve Upper Limb Functions in Patients With Sub-acute Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation (TENS)
Mirror Therapy (MT)
sham-Mirror Therapy (sham-MT)
Conventional Rehabilitation Program
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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;
  2. have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
  3. have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
  4. are able to score > 6 of 10 of abbreviated Mental Test;
  5. are able to follow instruction and give informed consent of the study.

Exclusion Criteria:

  1. Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
  2. Use cardiac pacemakers;
  3. Have receptive dysphasia;
  4. Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
  5. Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
  6. Have skin allergy that would prevent electrical stimulation;
  7. Are involved in drug studies or other clinical trials.

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT+TENS

sham-MT+TENS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 13, 2018
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03631628
Brief Title
Upper Limb Mirror Therapy With TENS to Improve Upper Limb Functions in Patients With Sub-acute Stroke
Official Title
A Randomized Controlled Clinical Trial of Upper Limb Training With Mirror Therapy (MT) and Transcutaneous Electrical Nerve Stimulation (TENS) to Improve Upper Limb Motor Functions in Patients With Sub-acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT+TENS
Arm Type
Experimental
Arm Description
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.
Arm Title
sham-MT+TENS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mirror Therapy (MT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sham-Mirror Therapy (sham-MT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Rehabilitation Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline
Description
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.
Time Frame
Baseline (0 week)
Title
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - midterm
Description
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.
Time Frame
3 weeks
Title
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - post-training
Description
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.
Time Frame
6 weeks
Title
Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - followup
Description
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.
Time Frame
10 weeks
Title
Wolf Motor Function Test (WMFT) - baseline
Description
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.
Time Frame
Baseline (0 week)
Title
Wolf Motor Function Test (WMFT) - midterm
Description
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.
Time Frame
3 weeks
Title
Wolf Motor Function Test (WMFT) - post-training
Description
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.
Time Frame
6 weeks
Title
Wolf Motor Function Test (WMFT) - followup
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (SIS) - baseline
Description
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.
Time Frame
Baseline (0 week)
Title
Stroke Impact Scale (SIS) - midterm
Description
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.
Time Frame
3 weeks
Title
Stroke Impact Scale (SIS) - post-training
Description
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.
Time Frame
6 weeks
Title
Stroke Impact Scale (SIS) - followup
Description
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.
Time Frame
10 weeks
Title
Grip Strength - baseline
Description
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).
Time Frame
Baseline (0 week)
Title
Grip Strength - midterm
Description
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).
Time Frame
3 weeks
Title
Grip Strength - post-training
Description
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).
Time Frame
6 weeks
Title
Grip Strength - followup
Description
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).
Time Frame
10 weeks
Title
Motor Activity Log (MAL) - baseline
Description
The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview. Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations. 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.
Time Frame
Baseline (0 week)
Title
Motor Activity Log (MAL) - midterm
Description
The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview. Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations. 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.
Time Frame
3 weeks
Title
Motor Activity Log (MAL) - post-training
Description
The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview. Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations. 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.
Time Frame
6 weeks
Title
Motor Activity Log (MAL) - followup
Description
The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview. Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations. 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.
Time Frame
10 weeks
Title
Community Integration Questionnaire (CIM) - baseline
Description
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.
Time Frame
Baseline (0 week)
Title
Community Integration Questionnaire (CIM) - midterm
Description
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.
Time Frame
3 weeks
Title
Community Integration Questionnaire (CIM) - post-training
Description
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.
Time Frame
6 weeks
Title
Community Integration Questionnaire (CIM) - followup
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shamay NG, PhD
Phone
+852 2766-4889
Email
shamay.ng@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamay Ng, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamay SM Ng, PhD
Phone
27664889
Email
Shamay.Ng@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Shamay SM Ng, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Upper Limb Mirror Therapy With TENS to Improve Upper Limb Functions in Patients With Sub-acute Stroke

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