Hemiplegia, Stroke
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERobot-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.
OTHERStandard of Care
60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP
Sponsors
University of Pennsylvania
Recupero Robotics LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Mercy Living Independently for Elders (LIFE) - West Philadelphia (Trinity Health Pace)
enAble Games LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 55 and older (based on who is admitted to the CBR site) * \>3 months post-stroke * Stroke diagnosis * Diagnosis of hemiparesis as a result of stroke (verified by radiology data) * Motor control score on Upper Extremity Fugl-Meyer scale \> 15 and \< 60; * Able to understand and speak * Upper arm manual muscle strength scores \>1 * Pain Scores \< 8 based on NIH Pain Intensity Scale
Exclusion criteria
* no cerebellum lesions due to stroke * severe cognitive function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Dexterity | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | 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. |
| Upper Extremity Function | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Quality of life (Participation) | at pre, at post-intervention (after 12 sessions), at follow-up | Measured by Neuro-QoL: Ability to Participate in Social Role and Activities Short Form. |
| Quality of life (Satisfaction) | at pre, at post-intervention (after 12 sessions), at follow-up | Measured by Neuro-QoL Satisfaction with Social Roles and Activities Short Form. |
| Motivation | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Motor Control | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | Measured by Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired. |
| Gross Hand Function | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | Measured by Box and Block (BnB) Test; metric # of blocks transferred. A higher score means less impaired. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exertion Level | at each of 12 therapy sessions | 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. |
| Pain Level | at each of 12 therapy sessions | 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. |
| Work Load | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Usability | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Cognition | After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up) | Measured by Montreal Cognitive Assessment (MocA) |
| Visual Spatial Attention | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Executive Function | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Active Joint Range of Motion (ROM) | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Passive Joint Range of Motion (ROM) | at pre, at post-intervention (after 12 sessions), at follow-up | 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. |
| Grip Strength | at pre, at post-intervention (after 12 sessions), at follow-up | Measured by NIH toolbox Grip Strength Test. The amount of pound-force is measured. The higher pound-force is better. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichelle J Johnson, PhD
University of Pennsylvania
PRINCIPAL_INVESTIGATORAlwyn Johnson, MS
Recupero Robotics LLC
Outcome results
None listed