Clinical trial NCT05542121: Rehab CARES In USA: Clinical Trial
Official title: Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Recupero Robotics LLC
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Mercy Living Independently for Elders (LIFE) - West Philadelphia (Trinity Health Pace)
name: enAble Games LLC
First posted: 2022-09-15
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Motor Control
timeFrame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
measure: Change in Gross Hand Function
timeFrame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
measure: Change in Hand Dexterity
timeFrame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
measure: Upper Extremity Function
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Quality of life (Participation)
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Quality of life (Satisfaction)
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Motivation
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
Secondary outcomes:
measure: Change in Cognition
timeFrame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
measure: Visual Spatial Attention
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Executive Function
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Active Joint Range of Motion (ROM)
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Passive Joint Range of Motion (ROM)
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Grip Strength
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Exertion Level
timeFrame: at each of 12 therapy sessions
measure: Pain Level
timeFrame: at each of 12 therapy sessions
measure: Usability
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Work Load
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Prediction of Motor Function
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
measure: Prediction of Cognitive Function
timeFrame: at pre, at post-intervention (after 12 sessions), at follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Recupero Robotics LLC
name: Alwyn Johnson, MS
role: PRINCIPAL_INVESTIGATOR
References: