Rehab CARES In USA: Clinical Trial

NCT05542121 | Completed FDA Device

• 2 other identifiers: 853607R42HD104325
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Hemiplegia

Outcome Measures

Primary Outcomes (7)

• Change in Motor Control

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

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

• Change in Gross Hand Function

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

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

• Change in Hand Dexterity

  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.

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

• Upper Extremity Function

  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.

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

• Quality of life (Participation)

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

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

• Quality of life (Satisfaction)

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

  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.

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

Secondary Outcomes (12)

• Change in Cognition

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

• Visual Spatial Attention

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

• Executive Function

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

• Active Joint Range of Motion (ROM)

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

• Passive Joint Range of Motion (ROM)

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

Study Arms (2)

Standard of Care

PLACEBO COMPARATOR

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

Robot-Assisted Therapy with Rehab CARES system

EXPERIMENTAL

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

Interventions

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.

Robot-Assisted Therapy with Rehab CARES system

Standard of Care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no cerebellum lesions due to stroke
• severe cognitive function

Sponsors & Collaborators

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

Study Sites (2)

Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia

Philadelphia, Pennsylvania, 19145, United States

Location

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michelle J Johnson, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Alwyn Johnson, MS

  Recupero Robotics LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 15, 2022
• Study Start: June 1, 2022
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 2 years of project end
• Access Criteria: Those wishing to see protocol and ICF will need to contact study PI

Locations

US (2)