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Completed

NCT Number: NCT05542121

Rehab CARES In USA: Clinical Trial

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-Assisted Therapy with Rehab CARES system

Device

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.

Standard of care

Other

60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP

Primary outcomes

  1. Change in Motor Control

    Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

    Measured by Change in Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired.

  2. Change in Gross Hand Function

    Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

    Measured by Changes in Box and Block (BnB) Test; metric # of blocks transferred. A higher score means less impaired.

  3. Change in Hand Dexterity

    Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

    Measured by changes in NIH Toolbox 9-Hole Pegboard Dexterity Test; metric time and # of peg transferred over time. A higher number of pegs means less impaired.

  4. Upper Extremity Function

    Time frame: at pre, at post-intervention (after 12 sessions), at follow-up

    Measured by changes in the 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.

  5. Quality of life (Participation)

    Time frame: at pre, at post-intervention (after 12 sessions), at follow-up

    Measured by changes in the Neuro-QoL: Ability to Participate in Social Role and Activities Short Form.

  6. Quality of life (Satisfaction)

    Time frame: at pre, at post-intervention (after 12 sessions), at follow-up

    Measured by changes in Neuro-QoL Satisfaction with Social Roles and Activities Short Form.

  7. Motivation

    Time frame: 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.

Secondary outcomes

  1. Change in Cognition

    Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)

    Measured by changes in Montreal Cognitive Assessment (MocA)

  2. Visual Spatial Attention

    Time frame: 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.

  3. Executive Function

    Time frame: 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.

  4. Active Joint Range of Motion (ROM)

    Time frame: 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.

  5. Passive Joint Range of Motion (ROM)

    Time frame: 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.

  6. Grip Strength

    Time frame: 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.

  7. Exertion Level

    Time frame: 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.

  8. Pain Level

    Time frame: 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.

  9. Usability

    Time frame: 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.

  10. Work Load

    Time frame: 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.

  11. Prediction of Motor Function

    Time frame: at pre, at post-intervention (after 12 sessions), at follow-up

    Measured by R-squared value from regression models of robot metrics from custom assessment tasks with respect to motor measurements of grip strength, gross hand function and fine motor function

  12. Prediction of Cognitive Function

    Time frame: at pre, at post-intervention (after 12 sessions), at follow-up

    Measured by R-squared value from regression models of robot metrics from custom assessment tasks with respect to cognitive measurements of overall cognition, attention and executive function.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Mercy Living Independently for Elders (LIFE) - West Philadelphia (Trinity Health Pace)
  • Recupero Robotics LLC
  • enAble Games LLC

Registry information

Official study title

Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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