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The goal of this clinical trial is to investigate the effectiveness of the developed application and exoskeleton robot devices for home-based training in stroke patients and patients with spinal cord injuries. The application that uses an Internet of Things (IoT) platform to enable remote monitoring of rehabilitation progress by clinical practitioners. Simultaneously, it seeks to assist the execution of patient movements through devices.
In patients with stroke, half of the participants will be assigned to experimental group, receiving a smart upper limb motor rehabilitation system for home program. The other half will be assigned to control group, receiving a traditional home program. In patients with spinal cord injuries. Participants will follow the same allocation method for home-based intervention.
Researchers will conduct an analysis before and after intervention, examining progress in motor function, activities of daily living, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke: TIGER group | Experimental | Participants in the TIGER (tenodesis-induced-grip exoskeleton robot) group will operate the TIGER system. They will undergo a 30-minute home-based training program twice a day, 5 days a week for 4 weeks. |
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| Stroke: TOT group | Active Comparator | Participants in the TOT (task-oriented training) group will receive task-oriented training as home program. They will undergo a 30-minute home-based training program twice a day, 5 days a week for 4 weeks. |
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| Spinal cord injury: TIGER group | Experimental | Participants in the TIGER (tenodesis-induced-grip exoskeleton robot) group will operate the TIGER system. They will undergo a 40-minute home-based training program once a day, 5 days a week for 4 weeks. |
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| Spinal cord injury: TOT group | Active Comparator | Participants in the TOT (task-oriented training) group will receive task-oriented training as home program. They will undergo a 40-minute home-based training program once a day, 5 days a week for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted therapy | Other | The TIGER system provides assistance for activities of daily living. Continuous passive mode of TIGER system provides passive range of motion as warm-up. Functional mode TIGER system provides functional training. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity -Stroke Group - Baseline | Fugl-Meyer Assessment - Upper Extremity is an assessment for the progress in the impairment of upper limb. 33 items in the FMA-UE include reflex activity, voluntary movement, and coordination of upper limb. 0 means movement cannot be performed, 1 means movement is partially performed and 2 means entirely performed. The minimal score is 0. The maximal score is 66. The minimal detectable change is considered 5.2. | Baseline, 4 weeks after baseline |
| Fugl-Meyer Assessment - Upper Extremity -Stroke Group - 4 weeks after baseline | Fugl-Meyer Assessment - Upper Extremity is an assessment for the progress in the impairment of upper limb. 33 items in the FMA-UE include reflex activity, voluntary movement, and coordination of upper limb. 0 means movement cannot be performed, 1 means movement is partially performed and 2 means entirely performed. The minimal score is 0. The maximal score is 66. The minimal detectable change is considered 5.2. | Baseline, 4 weeks after baseline |
| Motor Activity Log -Stroke Group - Baseline | Motor Activity Log is a semi-structured interview to understand functional performance in individual's home. The 30 questions ask patients about perceived difficulty in daily activities, including the amount of use of their affected arm and the quality of movement. The higher scores in the former mean the higher amount of patient using his weaker arm compared to before the stroke onset. The higher scores in the latter mean the higher movement quality during daily activities. The assessment is with a range of 0 to 5. Patients can give half scores if it is more reflective for their ratings. Adding all ratings, scores will take the average. The minimal score is 0. The maximal score is 5. The minimal detectable change value is considered 1.0-1.1. | Baseline, 4 weeks after baseline |
| Motor Activity Log -Stroke Group - 4 weeks after baseline | Motor Activity Log is a semi-structured interview to understand functional performance in individual's home. The 30 questions ask patients about perceived difficulty in daily activities, including the amount of use of their affected arm and the quality of movement. The higher scores in the former mean the higher amount of patient using his weaker arm compared to before the stroke onset. The higher scores in the latter mean the higher movement quality during daily activities. The assessment is with a range of 0 to 5. Patients can give half scores if it is more reflective for their ratings. Adding all ratings, scores will take the average. The minimal score is 0. The maximal score is 5. The minimal detectable change value is considered 1.0-1.1. |
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Inclusion Criteria: For patients with stroke
Inclusion Criteria: For patients with spinal cord injury
Exclusion Criteria: For patients with stroke
Exclusion Criteria: For patients with spinal cord injury
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li-Chieh Kuo, Ph.D | Contact | 886-62353535 | 5908 | jkkuo@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Li-Chieh Kuo, Ph.D | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng-Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Task-oriented training | Other | The TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach. |
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| Baseline, 4 weeks after baseline |
| Range of Motion -Stroke Group - Baseline | Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer. | Baseline, 4 weeks after baseline |
| Range of Motion -Stroke Group - 4 weeks after baseline | Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer. | Baseline, 4 weeks after baseline |
| Box and Block Test -Stroke Group - Baseline | Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent. | Baseline, 4 weeks after baseline |
| Box and Block Test -Stroke Group - 4 weeks after baseline | Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent. | Baseline, 4 weeks after baseline |
| Modified Tardieu Scale -Stroke Group - Baseline | Modifed Tardieu Scale is an assessment for the level of spasticity at wrist joint. According to the difficulty during passive joint stretching, the score ranges from 0 to 4 in an ordinal scale. 0 means no increase in muscle tone and 4 represents unfatigable clonus occurring at a precise angle. The angle of muscle reaction is measured with a goniometer to determine where spasticity occurs during passive stretching. | Baseline, 4 weeks after baseline |
| Modified Tardieu Scale -Stroke Group - 4 weeks after baseline | Modifed Tardieu Scale is an assessment for the level of spasticity at wrist joint. According to the difficulty during passive joint stretching, the score ranges from 0 to 4 in an ordinal scale. 0 means no increase in muscle tone and 4 represents unfatigable clonus occurring at a precise angle. The angle of muscle reaction is measured with a goniometer to determine where spasticity occurs during passive stretching. | Baseline, 4 weeks after baseline |
| Semmes-Weinstein monofilament test -Stroke Group - Baseline | Semmes-Weinstein monofilament test is an assessment for touch pressure threshold of hand. The evaluator uses nylon monofilaments of different diameters, exerting a constant force on skin for 1-1.5 seconds. The score is recorded as the finest filament that the participant could detect in at least 1 of the 3 trials. The thicker filament represents the higher score, indicating worse sensibility of hand. | Baseline, 4 weeks after baseline |
| Semmes-Weinstein monofilament test -Stroke Group - 4 weeks after baseline | Semmes-Weinstein monofilament test is an assessment for touch pressure threshold of hand. The evaluator uses nylon monofilaments of different diameters, exerting a constant force on skin for 1-1.5 seconds. The score is recorded as the finest filament that the participant could detect in at least 1 of the 3 trials. The thicker filament represents the higher score, indicating worse sensibility of hand. | Baseline, 4 weeks after baseline |
| System Usability Scale -Stroke Group - 4 weeks after baseline | System Usability Scale is a questionnaire for assessing effectiveness and satisfaction from user's subjective perspective. It consists of 10 items with a 5-point ordinal scale. 1 means strongly disagree and 5 means strongly agree. Score ranges from 0 to 100%. The threshold of good usability is 68%. | 4 weeks after baseline |
| Manual Muscle Testing -Spinal Cord Injury Group - Baseline | Manual Muscle Testing is an assessment for muscle strength in forearm and wrist muscles. It ranges from 0 to 5 in an ordinal scale. 0 means no contraction palpable and 5 means normal muscle strength. | Baseline, 4 weeks after baseline |
| Manual Muscle Testing -Spinal Cord Injury Group - 4 weeks after baseline | Manual Muscle Testing is an assessment for muscle strength in forearm and wrist muscles. It ranges from 0 to 5 in an ordinal scale. 0 means no contraction palpable and 5 means normal muscle strength. | Baseline, 4 weeks after baseline |
| Range of Motion -Spinal Cord Injury Group - Baseline | Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer. | Baseline, 4 weeks after baseline |
| Range of Motion -Spinal Cord Injury Group - 4 weeks after baseline | Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer. | Baseline, 4 weeks after baseline |
| Functional Independence Measure -Spinal Cord Injury Group - Baseline | Functional Independence Measure is an assessment for the functional independence status of an individual. It consists of 18 items with a 7-point ordinal scale. 1 means requiring total assistance and 7 means completely independent. | Baseline, 4 weeks after baseline |
| Functional Independence Measure -Spinal Cord Injury Group - 4 weeks after baseline | Functional Independence Measure is an assessment for the functional independence status of an individual. It consists of 18 items with a 7-point ordinal scale. 1 means requiring total assistance and 7 means completely independent. | Baseline, 4 weeks after baseline |
| Box and Block Test -Spinal Cord Injury Group - Baseline | Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent. | Baseline, 4 weeks after baseline |
| Box and Block Test -Spinal Cord Injury Group - 4 weeks after baseline | Box and Block Test is an assessment for hand dexterity. It starts with unaffected hand and involves moving blocks one by one from a box to another one within 60 seconds. The score for each hand is calculated separately. The more blocks the patient moves in 1 minute, the better hand dexterity. The minimal detectable change value is determined for improvement in performance with 5.5 blocks or increase in 18 percent. | Baseline, 4 weeks after baseline |
| WHO Quality of Life-BREF -Spinal Cord Injury Group - Baseline | WHO Quality of Life-BREF is a questionnaire for assessing subjective outcome of quality of life. It consists of 26 items with a 5-point ordinal scale. 1 means very dissatisfied and 5 means very satisfied. The scores are transformed linearly to a 0-100. | Baseline, 4 weeks after baseline |
| WHO Quality of Life-BREF -Spinal Cord Injury Group - 4 weeks after baseline | WHO Quality of Life-BREF is a questionnaire for assessing subjective outcome of quality of life. It consists of 26 items with a 5-point ordinal scale. 1 means very dissatisfied and 5 means very satisfied. The scores are transformed linearly to a 0-100. | Baseline, 4 weeks after baseline |
| Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology -Spinal Cord Injury Group - 4 weeks after baseline | Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology (T-QUEST) is a questionnaire for assessing user satisfaction with the use of assistive device. It consists of 12 items with a 5-point ordinal scale. 1 means not satisfied at all and 5 means very satisfied. The assessment has a range of 0 to 5. | 4 weeks after baseline |
| Chi Mei Medical Center | Recruiting | Tainan | 710 | Taiwan |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |