R3THA Rehabilitation Feasibility and Usability Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Box and Blocks Test
Study Overview
Brief Summary
The purpose of this study is to assess how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •must be between the ages of 20 and 80
- •must have enough movement in my arms and hands to actively interact with the video games as determined by study staff
- •must have internet access at home.
- •must be comfortable performing basic functions on a computer, such as browsing the internet.
- •must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff.
Exclusion Criteria
- •Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff.
- •Thinking problems or have difficulty following instructions 3) Unable to interact with an entire computer screen due to spatial neglect 4) Difficulty understanding words spoken to me (Receptive aphasia) 5) Any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) Severe arthritis that limits hand and arm movements 7) Not independent in functional activities/mobility prior to stroke
Arms & Interventions
Stroke
The study will enroll up to 10 participants with stroke who will be paired with trained therapists to receive R3THA telerehabilitation. The participants with stroke will participate in 7 training sessions. The training includes hand and arm exercises.
Intervention: RETHA (Other)
Outcomes
Primary Outcomes
Box and Blocks Test
Time Frame: 5 weeks
box and blocks test is standard measure for hand dexterity and hand-eye coordination
Action Research Arm Test
Time Frame: 5 weeks
The standard assessment for functional performance in individuals with stroke
Kinematic Assessment
Time Frame: 5 weeks
Kinematic assesment to measure range of motion of the hand and arm
System Usability Survey
Time Frame: 5 weeks
System Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.
Exergame Questionnaire
Time Frame: 5 weeks
It is a questionnaire developed to assess qualitative performance of the device
Performance Survey
Time Frame: 5 weeks
It is a qualitative questionnaire with interview aimed at gauging the feasibility of integrating R3THA into the daily routines of individual with stroke/end users.
Fugl-Meyer Assessment for Upper Extremity
Time Frame: 5 weeks
A standard clinical measure to assess the level of motor impairment in individuals with stroke.
Secondary Outcomes
- Montreal Cognitive Assessment Test (MOCA)(1 week)
Investigators
Kiran Karunakaran
Research Scientist
Kessler Foundation