StrokeNCT06215625
A Feasible Smart Upper Limb Rehabilitation Model for Patients With Stroke and Spinal Cord Injuries
A study testing Robot-assisted therapy and Task-oriented training in people with Stroke and Spinal Cord Injuries, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries
- What is being tested?
- Robot-assisted therapy and Task-oriented training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2024to 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-79 years old.
- The score of Montreal Cognitive Assessment is more than or equal to 26.
- The unilateral hemorrhagic or ischemic participants.
- The performance of upper limb movement is affected by damage to brain cells.
- 20-65 years old.
- The score of Mini-Mental Status Examination is more than or equal to 25.
- Diagnosed as incomplete spinal cord injury at the C5 or C6 level.
Who cannot join
- Underwent sugery on the shoulder, elbow or wrist.
- Severe pain in upper limb.
- Another muscular or neurological diseases that effects motor performance.
- Underwent sugery on the shoulder, elbow or wrist.
- Severe pain in upper limb.
- Another muscular or neurological diseases that effects motor performance.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Li-Chieh Kuo, 886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw
- Recruiting
Chi Mei Medical Center
Tainan, 710
Lin-Yen Chang, B.S., 886-2812811 ext. 55010, lyenchin67@gmail.com
About this study
Official title: Establishment of a Feasible Smart Upper Limb Rehabilitation Model in Post-pandemic Era: Examples for Patients With Stroke and Spinal Cord Injuries
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.
- Conditions
- Stroke, Spinal Cord Injuries
- Being tested
- Robot-assisted therapy, Task-oriented training
- Keywords
- stroke, spinal cord injury, robot-assisted therapy, tele-rehabilitation
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted therapyOther
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.
Task-oriented trainingOther
The TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Robot-assisted therapy |
| 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. Receives: Other: Task-oriented training |
| 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. Receives: Other: Robot-assisted therapy |
| 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. Receives: Other: Task-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJun 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.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Chieh Kuo, Ph.D, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215625
- Sponsor's protocol ID
- A-ER-110-563
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Feasible Smart Upper Limb Rehabilitation Model in Post-pandemic Era: Examples for Patients With Stroke and Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT06215625
- Acronym / sponsor ID
- A-ER-110-563
- Conditions
- Stroke, Spinal Cord Injuries
- Keywords
- stroke, spinal cord injury, robot-assisted therapy, tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stroke: TIGER group | Experimental | Other: Robot-assisted therapyParticipants 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. |
| Stroke: TOT group | Active comparator | Other: Task-oriented trainingParticipants 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. |
| Spinal cord injury: TIGER group | Experimental | Other: Robot-assisted therapyParticipants 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. |
| Spinal cord injury: TOT group | Active comparator | Other: Task-oriented trainingParticipants 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 20-79 years old.
- The score of Montreal Cognitive Assessment is more than or equal to 26.
- The unilateral hemorrhagic or ischemic participants.
- The performance of upper limb movement is affected by damage to brain cells.
- 20-65 years old.
Key exclusion criteria (6 listed)
- Underwent sugery on the shoulder, elbow or wrist.
- Severe pain in upper limb.
- Another muscular or neurological diseases that effects motor performance.
- Underwent sugery on the shoulder, elbow or wrist.
- Severe pain in upper limb.
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 |
|---|---|---|
| Robot-assisted therapyThe 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. | Other | Spinal cord injury: TIGER group, Stroke: TIGER group |
| Task-oriented trainingThe TOT group will practice sensorimotor techniques for warming up, and then they will practice various functional tasks based on task-oriented approach. | Other | Spinal cord injury: TOT group, Stroke: TOT group |
Primary outcome
Fugl-Meyer Assessment - Upper Extremity -Stroke Group - Baseline
Time frame: Baseline, 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.
Fugl-Meyer Assessment - Upper Extremity -Stroke Group - 4 weeks after baseline
Time frame: Baseline, 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.
Motor Activity Log -Stroke Group - Baseline
Time frame: Baseline, 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.
Motor Activity Log -Stroke Group - 4 weeks after baseline
Time frame: Baseline, 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.
Range of Motion -Stroke Group - Baseline
Time frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Range of Motion -Stroke Group - 4 weeks after baseline
Time frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Box and Block Test -Stroke Group - Baseline
Time frame: Baseline, 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.
Box and Block Test -Stroke Group - 4 weeks after baseline
Time frame: Baseline, 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.
Modified Tardieu Scale -Stroke Group - Baseline
Time frame: Baseline, 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.
Modified Tardieu Scale -Stroke Group - 4 weeks after baseline
Time frame: Baseline, 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.
Semmes-Weinstein monofilament test -Stroke Group - Baseline
Time frame: Baseline, 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.
Semmes-Weinstein monofilament test -Stroke Group - 4 weeks after baseline
Time frame: Baseline, 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.
System Usability Scale -Stroke Group - 4 weeks after baseline
Time frame: 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%.
Manual Muscle Testing -Spinal Cord Injury Group - Baseline
Time frame: Baseline, 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.
Manual Muscle Testing -Spinal Cord Injury Group - 4 weeks after baseline
Time frame: Baseline, 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.
Range of Motion -Spinal Cord Injury Group - Baseline
Time frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Range of Motion -Spinal Cord Injury Group - 4 weeks after baseline
Time frame: Baseline, 4 weeks after baseline
Range of Motion is an assessment to evaluate the movements in forearm and wrist joints with a goniometer.
Functional Independence Measure -Spinal Cord Injury Group - Baseline
Time frame: Baseline, 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.
Functional Independence Measure -Spinal Cord Injury Group - 4 weeks after baseline
Time frame: Baseline, 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.
Box and Block Test -Spinal Cord Injury Group - Baseline
Time frame: Baseline, 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.
Box and Block Test -Spinal Cord Injury Group - 4 weeks after baseline
Time frame: Baseline, 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.
WHO Quality of Life-BREF -Spinal Cord Injury Group - Baseline
Time frame: Baseline, 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.
WHO Quality of Life-BREF -Spinal Cord Injury Group - 4 weeks after baseline
Time frame: Baseline, 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.
Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology -Spinal Cord Injury Group - 4 weeks after baseline
Time frame: 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.
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 22 Jan 2024.
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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.
Li-Chieh Kuo, Ph.D principal investigator
National Cheng Kung 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 Robot-assisted therapy and Task-oriented training in people with Stroke and Spinal Cord Injuries, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
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 7 inclusion and 6 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 22 Jan 2024. 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 Taiwan. 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. 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 Li-Chieh Kuo, Ph.D (886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment - Upper Extremity -Stroke Group - Baseline (time frame: Baseline, 4 weeks after baseline). The study lists 24 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 22 Jan 2024.