Acute Stroke Clinical Trial
Official title:
The Effect of EMG-Driven Exoskeleton Robotic Rehabilitation on Improving Hand Functions in Acute Stroke Patients
Verified date | September 2021 |
Source | Bahçesehir University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The advantage of the EMG-driven exoskeletons is that patient's own muscle power known as Residual Muscle Power is used to move the extremity while many other robotic devices work and drive impaired limb based on machine directed force. However, it is not clear which group of patients are suitable for EMG driven exoskeletons use and there has not been any established treatment protocol. The aims of the study are 1- to investigate the effectiveness of the EMG-driven exoskeleton for hand rehabilitation in patients with acute stroke. 2- to understand which group of the patients may give the best response to the EMG-driven technology and how should be the treatment protocol designed.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 31, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Having ischemic stroke history within last 4 weeks - Being at the age 18 and older than 18 - Providing a sitting balance during the robot training (maximum 1 hour with preparation time) - Understanding and performing simple commands - Full range of motion in MCP, PIP and DIP - MAS < 3 for finger flexors and extensors - Participants who agree to participate in the study Exclusion Criteria: - Recurrent stroke - Other neurologic or orthopedic problems that may affect to upper extremity functions - Hemispatial neglect (will be diagnosed by Line bisection test and The star cancellation test) - Refused treatment, non-cooperation - MAS = 3 (MAS will be measured every week during the treatment period) |
Country | Name | City | State |
---|---|---|---|
Turkey | Dilber Karagozoglu Coskunsu | Istanbul | Europe |
Lead Sponsor | Collaborator |
---|---|
Bahçesehir University | Medical Park Hospital Istanbul, Medipol University, Rehab-Robotics Company Limited |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Upper Extremity Assessment: | Fugl-Meyer assessment was first used in 1975 to assess post-stroke physical performance. 33-item upper extremity subscale of the Fugl-Meyer scale evaluates movements, coordination/speed and pain in the shoulder, elbow, forearm. The highest score for the upper extremity is 66. | Change from pre-interventional Fugl-Meyer Upper Extremity score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks. | |
Secondary | Action Research Arm Test (ARAT) | ARAT is a performance test, first described by Lyle in 1982. This test is produced by the upper extremity function test and shows upper extremity function and skill. ARAT consists of four subdivisions and 19 functional items that evaluate grasp, grip, pinch and gross motor movement on the both side. The highest score is 57. | Change from pre-interventional ARAT score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks. | |
Secondary | Motor Activity Log | Motor Activity Log is a measure used to assess the amount of use and quality of movement of paretic arms and hands in daily living activities for hemiparetic stroke patients. It consists of 30 items. | Change from pre-interventional Motor Activity Log score at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks. | |
Secondary | Manuel muscle testing | manuel muscle testing of the flexor and extensor muscles of the wrist and finger | Change from pre-interventional Manuel muscle testing scores at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks. | |
Secondary | Range of motion measurement (ROM) | Active range of motion of the wrist, MCP, PIP and DIP joints | Change from pre-interventional ROMs at the end of the 15 sessions intervention that will be performed 5 days in a week at a total of 3 weeks. | |
Secondary | Force and EMG measurement with the testing device | Additional force and EMG measurement with the specially designed testing device | Change from pre-interventional force and EMG measurement with the testing device at the end of the 5th session, 10th session and 15 session intervention that will be performed at the last session of each week at a total of 3 weeks. | |
Secondary | hand dynamometer | to measure grip strength | Change from pre-interventional grip strentgh at the end of the 15 session interventions that will be performed 5 days in a week at a total of 3 weeks. |
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