Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES): Usability Study
Brief description of study
Stroke is the leading cause of serious long-term disability. It is estimated that 5.86.5 million people currently live with stroke related disability in the US and that this number will increase by 20.5% by 2030. The current US health infrastructure is not prepared for these increasing numbers. Limitations in health insurance coverage and the shortage of rehabilitation practitioners decrease access to rehabilitation. Community-based settings are becoming viable venues for delivering long-term post-stroke care, however, they are plagued by staff with limited expertise, low number of therapists and lack of financial resources for rehabilitation. Because of this, the quality of care is compromised, and functional outcomes of patients are not equal to hospital-based rehabilitation settings. We seek to develop a novel solution to this problem. Implementing affordable design is a fundamental strategy for increasing access to rehabilitation technology for patients regardless of socio-economic status. Doing so, decreases healthcare disparities and reduces long-term healthcare costs. We propose to use affordable robots to improve access to quality rehabilitation care in low-resource, community-based settings.
Detailed description of study
The study activities will take place at Rehabilitation Robotics Lab located at Penn Medicine Rittenhouse at 1800 Lombard Street, Philadelphia, PA 19146.
We are looking for participants for our Test group: People with Stroke who are above the age of 18 and older.
ASSESSMENT PORTION:
The assessment portion of the study should take one session of approximately four hours with rest times built in and involves you completing cognitive and motor clinical assessment scales and then using a robot to complete several assessment and gaming tasks.
If all assessment tasks can't be completed in 1 session you will be asked to come back for a second session.
Subjects will be screened for eligibility and then upon arrival at the School of Medicine, will be screened using the university's Covid-19 procedures, including use of personal protective equipment and sanitization procedures.
This part of the study pays $50.00 compensation at the end.
FOCUS GROUP PORTION:
After using the robot, you will be asked to give your feedback on the experience. If you agree you will be invited back for a third session.
The Focus group will be conducted by an experienced interviewer.
You will be asked about your experience with the robot and the tasks you did with it.
The focus group will also probe usability issues including font size, sound levels, speed of game, button size, etc.
Each focus group will be limited to 120 minutes in length and will be audio recorded and transcribed by a HIPAA compliant transcriptionist.
Participation in the focus group pays an additional $50.00.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
stroke,hemiplegia
-
Age: Between 18 Years - 75 Years
-
Gender: All
Key inclusion criteria Phase 1Patients with Stroke Age 18 and older 3 months post-stroke Stroke diagnosis excluding cerebellum lesions Diagnosis of hemiparesis as a result of stroke (verified by radiology data) Motor control score on UE Fugl-Meyer scale between 15 and 66; Cognitive score not more than moderate on MoCA (Montreal Cognitive Assessment) score greater than 17 Able to understand and speak MoCA sub-domain score in language greater than 4 Upper arm manual muscle strength scores greater than 1 Pain Scores less than 8 based on NIH Pain Intensity Scale Upper arm spasticity less than 4 based on Ashworth scale |
Key exclusion criteria Participants will be excluded if they present with 1) moderate or severe language deficits (MoCA language subdomain less than 4), 2) greater than mild depression indicated by a Neuro-QoL Depression Measure Short Form; 3) NIH Pain Intensity Measure; 4) Ashworth spasticity scores greater than 4 which makes passive movement difficult and voluntary movement nearly impossible, or 5) if they have lesions in the cerebellum. |
Updated on
05 Jul 2023.
Study ID: 849090
