Effect on Upper Limb Training Using Rehabilitation Robot With Human-Computer Interaction Game Interface for Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment
Study Overview
Brief Summary
A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists.
Detailed Description
NTUH-ii is an upper limb rehabilitation robot. The aim of this robot is to reduce the workload of rehabilitation therapists and make the rehabilitation process more effective.
The robot can complete rehabilitation tasks, such as elbow flexion/extension, shoulder flexion/extension, and shoulder horizontal abduction/adduction, etc. By giving the desired trajectory, the robot can lead patients to do the tasks in passive mode or active mode.
However, curative rehabilitation should include the motion intention of patients. This study aimed to investigate the efficacy of rehabilitation effect by combining the sensors (such as sEMG, IMU) to obtain the motion intention of patients and give the assistive movement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia.
- •Able to understand and follow simple instructions.
- •Able to maintain a sitting posture balance.
- •Rank on the Brunnstrom Scale is between two and five.
- •Both ischemic and hemorrhagic strokes are included.
Exclusion Criteria
- •Not yet fully conscious.
- •Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities.
- •Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks.
- •Severe aphasia preventing compliance with researchers' instructions for this study.
- •Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest.
- •Patients with a severe systemic illness requiring bed rest.
- •Patients with shoulder joint pathology unable to undergo exercise therapy.
- •Patients with severe osteoporosis who have concerns about fractures during physical activity.
- •Patients with arrhythmia and implanted cardiac pacemakers.
- •Severe uncontrolled seizures that cannot be improved with medication, physical therapy, botulinum toxin injections, or phenol block procedures.
Outcomes
Primary Outcomes
Fugl-Meyer Assessment
Time Frame: 1 month
Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.
Secondary Outcomes
- sEMG analyzation(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Wolf Motor Function Test(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Motor evoked potential(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Fugl-Meyer Assessment(Before the task and right away the experiment, 3 months, 6 months post intervention.)
- Modified Ashworth Scale(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)
- Stroke Impact Scale(Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.)