StrokeNCT05542121

Rehab CARES In USA: Clinical Trial

A study testing Robot-Assisted Therapy with Rehab CARES system in people with Stroke and Hemiplegia, run by University of Pennsylvania at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Stroke, Hemiplegia
What is being tested?: Robot-Assisted Therapy with Rehab CARES system
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 2 sitesUnited States
Study dates: 1 Jun 2022to 30 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

no cerebellum lesions due to stroke
severe cognitive function

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Mercy Living Independently for Elders (L.I.F.E) - West Philadelphia
Philadelphia, Pennsylvania, 19145
Penn Medicine Rittenhouse
Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

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

Read the 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.

Conditions: Stroke, Hemiplegia
Being tested: Robot-Assisted Therapy with Rehab CARES system, Standard of Care
Medical subject headings: Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Robot-Assisted Therapy with Rehab CARES systemDevice
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 CareOther
60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP

Study groups in NCT05542121
Study group	Role	What they receive
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). Receives: 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) Receives: Device: Robot-Assisted Therapy with Rehab CARES system

What is being measured

The primary outcome is the main question the study is designed to answer.

Motor Control
Measured by Upper Extremity Fugl-Meyer Assessment (UE-FM); scale is out of 66. A lower score means more impaired.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at pre, at post-intervention (after 12 sessions), at follow-up

Secondary outcomes (10)

Cognition
Measured by Montreal Cognitive Assessment (MocA)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at pre, at post-intervention (after 12 sessions), at follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202230 Aug 2025

First posted15 Sep 2022
Study start1 Jun 2022
Primary completion30 Aug 2025
Study completion30 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05542121
Sponsor's protocol ID: 853607
Other IDs: R42HD104325
Status last verified: Aug 2026
First submitted: 6 Sep 2022
Last updated: 3 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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.

Publications

Azar RM, Sobotka NS, Cacchione P, Mendonca RJ, Johnson MJ. Evaluating the Relationship Between Motor and Cognitive Impairment and Lesion Size and Location Post-Stroke Using CT Scans. IEEE Int Conf Rehabil Robot. 2025 May;2025:1467-1472. doi: 10.1109/ICORR66766.2025.11063052.
PubMed 40644125
Shang Y, Bahrami S, Gaardsmoe S, Johnson A, Johnson MJ, Diefenbach P. General Purpose Haptic/Biometric-Based Dynamic Difficulty Adjustment for Post-Stroke Upper-Limb Rehabilitation Games. IEEE Int Conf Rehabil Robot. 2025 May;2025:248-253. doi: 10.1109/ICORR66766.2025.11062998.
PubMed 40644162
Waters EL, Johnson MJ. Motor Learning in Robot-Based Haptic Dyads: A Review. IEEE Trans Haptics. 2024 Oct-Dec;17(4):510-527. doi: 10.1109/TOH.2024.3379035. Epub 2024 Dec 19.
PubMed 38502611
Waters EL, Mendonca RJ, Cacchione PZ, Johnson MJ. TheraDyad: Feasibility of an Affordable Robot for Multi-User Stroke Rehabilitation. Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron. 2024 Sep;2024:1498-1503. doi: 10.1109/biorob60516.2024.10719912. Epub 2024 Oct 23.
PubMed 40503389
Waters EL, Azar R, Opong-Duah J, Gaardsmoe S, Johnson A, Mendonca RJ, Cacchione PZ, Johnson MJ. Towards an Optimal Model of Post-Stroke Sensorimotor Control. IEEE Int Conf Rehabil Robot. 2025 May;2025:1313-1319. doi: 10.1109/ICORR66766.2025.11063066.
PubMed 40644119
Meng NY, Waters EL, Lin G, Gaardsmoe S, Johnson A, Hallock LA, Mendonca RJ, Cacchione PZ, Johnson MJ. Analysis of Induced Muscle Activations by an Affordable, Reconfigurable Robot for Comprehensive Post-Stroke Rehabilitation. IEEE Int Conf Rehabil Robot. 2025 May;2025:1361-1367. doi: 10.1109/ICORR66766.2025.11063060.
PubMed 40644148

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rehabilitation Using Community-Based Affordable Robotic Exercise Systems (Rehab CARES)
ClinicalTrials.gov ID: NCT05542121
Acronym / sponsor ID: 853607
Conditions: Stroke, Hemiplegia
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: 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 start: 1 Jun 2022 (actual)
Primary completion: 30 Aug 2025 (actual)
Study completion: 30 Aug 2025 (actual)
First posted: 15 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard of Care	Placebo comparator	Other: Standard of Care60 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).
Robot-Assisted Therapy with Rehab CARES system	Experimental	Device: Robot-Assisted Therapy with Rehab CARES system60 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)

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (2 listed)

no cerebellum lesions due to stroke
severe cognitive function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Robot-Assisted Therapy with Rehab CARES system60 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.	Device	Robot-Assisted Therapy with Rehab CARES system
Standard of Care60 min sessions; 3 sessions per week; for 4 weeks of OT, PT, and SLP	Other	Standard of Care

Primary outcome

Motor Control
Time frame: 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
Time frame: 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.
Hand Dexterity
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Measured by Neuro-QoL Satisfaction with Social Roles and Activities Short Form.
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.

10 secondary outcomes

Cognition
Time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)
Visual Spatial Attention
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Executive Function
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Active Joint Range of Motion (ROM)
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Passive Joint Range of Motion (ROM)
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Grip Strength
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Exertion Level
Time frame: at each of 12 therapy sessions
Pain Level
Time frame: at each of 12 therapy sessions
Usability
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up
Work Load
Time frame: at pre, at post-intervention (after 12 sessions), at follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Background: PubMed 40644125Azar RM, Sobotka NS, Cacchione P, Mendonca RJ, Johnson MJ. Evaluating the Relationship Between Motor and Cognitive Impairment and Lesion Size and Location Post-Stroke Using CT Scans. IEEE Int Conf Rehabil Robot. 2025 May;2025:1467-1472. doi: 10.1109/ICORR66766.2025.11063052.
Background: PubMed 40644162Shang Y, Bahrami S, Gaardsmoe S, Johnson A, Johnson MJ, Diefenbach P. General Purpose Haptic/Biometric-Based Dynamic Difficulty Adjustment for Post-Stroke Upper-Limb Rehabilitation Games. IEEE Int Conf Rehabil Robot. 2025 May;2025:248-253. doi: 10.1109/ICORR66766.2025.11062998.
Background: PubMed 38502611Waters EL, Johnson MJ. Motor Learning in Robot-Based Haptic Dyads: A Review. IEEE Trans Haptics. 2024 Oct-Dec;17(4):510-527. doi: 10.1109/TOH.2024.3379035. Epub 2024 Dec 19.
Background: PubMed 40503389Waters EL, Mendonca RJ, Cacchione PZ, Johnson MJ. TheraDyad: Feasibility of an Affordable Robot for Multi-User Stroke Rehabilitation. Proc IEEE RAS EMBS Int Conf Biomed Robot Biomechatron. 2024 Sep;2024:1498-1503. doi: 10.1109/biorob60516.2024.10719912. Epub 2024 Oct 23.
Background: PubMed 40644119Waters EL, Azar R, Opong-Duah J, Gaardsmoe S, Johnson A, Mendonca RJ, Cacchione PZ, Johnson MJ. Towards an Optimal Model of Post-Stroke Sensorimotor Control. IEEE Int Conf Rehabil Robot. 2025 May;2025:1313-1319. doi: 10.1109/ICORR66766.2025.11063066.
Background: PubMed 40644148Meng NY, Waters EL, Lin G, Gaardsmoe S, Johnson A, Hallock LA, Mendonca RJ, Cacchione PZ, Johnson MJ. Analysis of Induced Muscle Activations by an Affordable, Reconfigurable Robot for Comprehensive Post-Stroke Rehabilitation. IEEE Int Conf Rehabil Robot. 2025 May;2025:1361-1367. doi: 10.1109/ICORR66766.2025.11063060.
Individual participant dataSharing planned: 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.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michelle J Johnson, PhD principal investigator

University of Pennsylvania

Alwyn Johnson, MS principal investigator

Recupero Robotics LLC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Robot-Assisted Therapy with Rehab CARES system in people with Stroke and Hemiplegia, run by University of Pennsylvania at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor Control (time frame: After 12 sessions (post-pre), after follow-up at 4 weeks (post-follow-up)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05542121, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.