Determinants of the Effectiveness of Robot-assisted Hand Movement Training
- Conditions
- Cerebrovascular Accident (CVA)Stroke, Ischemic
- Interventions
- Device: New FINGER
- Registration Number
- NCT04818073
- Lead Sponsor
- University of California, Irvine
- Brief Summary
The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.
- Detailed Description
From previous studies, the investigators learned that stroke survivors with impaired finger proprioception did not achieve as large a functional benefit from robotic finger training. For this study, the investigators would like to determine if and the extent of finger proprioception can be improved through targeted robotic proprioceptive training combined with robotic finger movement training. The investigators would also include imagining studies via Electroencephalogram (EEG) and other baseline predictors to provide insight to determine who responds best to proprioceptive training.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age 18 to 85 years
- Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment
- An ability to score at least 3 blocks on the Box and Block Test
- A substantial decrease in alertness, language reception or attention
- Pregnant or lactating
- Advanced liver, kidney, cardiac or pulmonary disease
- Plan to alter any current participation in other rehabilitation therapy in the time period of the study
- A terminal medical diagnosis consistent with survival < 1 year
- Coexistent major neurological disease
- Coexistent major psychiatric disease
- A history of significant alcohol or drug abuse in the prior 3 years
- Current enrollment in another study related to stroke or stroke recovery
- Any other medical contraindication to participation in this study evaluated by our team physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B New FINGER Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks. Group A New FINGER Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks. Group C New FINGER Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.
- Primary Outcome Measures
Name Time Method Box and Blocks Test From baseline to 1-month post intervention We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
- Secondary Outcome Measures
Name Time Method Motor Activity Log From baseline to 1-month post intervention We will measure the change of the Motor Activity Log (MAL) mean scores from the baseline evaluation to 1-month post intervention. The Motor Activity Log is a 30 questionnaire that collect subjective measure of an individual's real life functional upper limb performance. The higher scores indicate a better outcome.
Changes in finger proprioception measured using the Crisscross Assessment. From baseline to 1-month post intervention We will measure the change in finger proprioception scores from the baseline evaluation to 1-month post intervention. Finger proprioception is measured by using the FINGER Crisscross Assessment which we slowly move the index and middle fingers with the FINGER robot past each other without any visual input. We then ask study participants to press a key when they feel the fingers are overlapped. Finger proprioception is measured by the error which will be quantified as the mean magnitude of finger separation error at the metacarpal joint when the key is pressed. The lower scores indicate a better outcome.
Fugl-Meyer Motor Assessment of the Upper Extremity From baseline to 1-month post intervention We will measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 1-month post intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. The higher scores indicate a better outcome.
Trial Locations
- Locations (1)
University of California Irvine
🇺🇸Irvine, California, United States