An interventional study of Robot-Assisted Therapy with Rehab CARES system and Standard of Care in Stroke and Hemiplegia, sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
In Phase 2, Patients in a community-based setting who have had a stroke will be evaluated by rehabilitation professionals and asked to perform a battery of clinical assessments before and after standard of care and robot assisted therapy with Rehab CARES system of simple force-feedback robots that are adapted to deliver single and group therapy.
In Phase 2, we will develop the hardware to allow three haptic robots to dock (a gym) and be configured to allow patients to play therapy games alone or collaboratively. We will test the safety and feasibility of the gym in a community-based rehabilitation setting. We will treat 36 patients randomized to either a control group getting standard of care therapy and a robot group receiving standard of care with upper limb therapy being given using the robot gym instead of an occupational therapist. Therapy will occur over 4 weeks with two follow-up assessments. Key milestones will be to show that the robot group has the same or better functional outcomes, motivation, and adverse events as the control group. Also to show that the robot gym is a cost-effective solution to increasing access to quality rehabilitation care in low-resource, community-based settings. Success here will validate this potential solution, justify design changes revealed via user-feedback and a larger clinical trial.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 27 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
60 min OT sessions; 3 sessions per week; for 4 weeks;-- augmented Standard therapy - consisting of PT, OT and SLP. Clinical Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2).
Other: Standard of Care
60 min sessions; 3 sessions per week; for 4 weeks;----of Upper Limb therapy using 1 or more affordable robots. Robot sessions can be group play and/or single play. Robot Assessment (B1-pre, B2-post, B3-follow-up#1, B4-follow-up#2)
Device: Robot-Assisted Therapy with Rehab CARES system
60 min sessions; 3 sessions per week; for 4 weeks; Patients uses 1 or more affordable robots to exercise the UL with adaptive games assessments as OT; standard of care PT and SLP; Subjects' motor and cognitive impairment will be used to set the game and modes. The game parameters will be adjusted according to motor and cognitive impairment of that station's user while the controller will automatically adjust assisting or resisting torques experienced. The 60 minutes will be broken up into 15-minute training intervals.
60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP
Motor Control
Measured by Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired.
Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Gross Hand Function
Measured by Box and Block (BnB) Test; metric # of blocks transferred. A higher score means less impaired.
Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Hand Dexterity
Measured by NIH Toolbox 9-Hole Pegboard Dexterity Test; metric time and # of peg transferred over time. A higher number of pegs means less impaired.
Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Upper Extremity Function
Measured by Neuro-QoL: Upper Extremity Function - Fine Motor, ADL Short Form. Short form is a self-report on 8 items to assesses fine motor function and activity of daily living in upper arm.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Quality of life (Participation)
Measured by Neuro-QoL: Ability to Participate in Social Role and Activities Short Form.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Quality of life (Satisfaction)
Measured by Neuro-QoL Satisfaction with Social Roles and Activities Short Form.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Motivation
Measured by the Self-Assessment Manikin (SAM) scale which consist of 3 subscales: enjoyment, engagement, and control. Each subscale is from 0 to 9. For enjoyment and engagement the higher score is the better and for control the lower score is better.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Cognition
Measured by Montreal Cognitive Assessment (MocA)
Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Visual Spatial Attention
Measured by changes in Color Trails 1.A timed trail making assessment. A faster time result is better. Timed results are normalized by age and education and reported as a normalized z-score.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Executive Function
Measured by performance on Color Trails 2. A timed trail making assessment. A lower time is better. Timed results are normalized by age and education and reported as a normalized z-score.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Active Joint Range of Motion (ROM)
Range of Motion joint testing of the upper limb. Subjects shoulder, elbow, and wrist joint active joint movements are evaluated in the impaired arm. Reported in degrees.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Passive Joint Range of Motion (ROM)
Range of Motion joint testing of the upper limb. Subjects shoulder, elbow, and wrist joint passive joint movements are evaluated in the impaired arm. Reported in degrees.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Grip Strength
Measured by NIH toolbox Grip Strength Test. The amount of pound-force is measured. The higher pound-force is better.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Exertion Level
Measured by score on Borg Exertion Scale. Score is from 0 to 10. 0 is low and 10 is max. Subjects are asked to report pain experienced during a 60 minute session. Exertion between 0 and 6 is expected.
Time frame: at each of 12 therapy sessions
Pain Level
Measured by score on Visual Analog Pain Scale. Patients indicate a pain score is from 0 to 10. 0 is low and 10 is max. Subjects are asked to report pain experienced during a 60 minute session. Pain \< 4 is expected.
Time frame: at each of 12 therapy sessions
Usability
Measured by score on System Usability Scale. Score is from 0 to 100. 0 is low and 100 is max. A score greater than or equal to 68 is ideal.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Work Load
Measured by NASA TLX Task Demand Scale. The scale consist of 6 questions scored on a likert scale of 0 to 21. The responses are processed to define a workload score. A workload score at or above 37 which is MOD-HIGH is expected.
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — It is a priority of the research team to share primary data collected as a result of this project with other researchers and the National Institute of Health and associated funding agents. Findings will be disseminated within a reasonable time via newsletters sponsored by the institutions involved, peer-reviewed conference papers and journals. All journal papers will be placed on PubMed and made publically accessible. All acknowledgements will clearly define the funding agency and follow guidelines stipulated by the NIH. Copies of all publications will provided promptly. All copyright procedures will comply with the standard of NIH copyright clause. After study completion, de-identified data sets will be available to NIH and to other investigators contingent on the execution of relevant institutional data use agreements.
Supporting information: Study protocol, Icf
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