Robot-Assisted Therapy for Stroke

Recruiting at 1 trial location

Overseen By Rochelle J Mendonca, PhD, OT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Cerebellum lesions, severe cognitive, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how robot-assisted therapy can aid stroke recovery. It specifically uses the Rehab CARES system, which employs simple robots to assist with therapy. The trial compares standard therapy to this new robot-assisted approach to determine if the robots can improve arm function. Individuals who experienced a stroke more than three months ago and have weakness on one side of their body might be suitable for this study. As an unphased trial, participants can contribute to groundbreaking research that could enhance stroke recovery therapies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Rehab CARES system is safe for stroke patients?

Research has shown that robot-assisted therapy, such as the Rehab CARES system, is generally safe for stroke patients. Studies have found that patients tolerate this type of therapy well. For example, systems like Rehab CARES have been used in various settings and have aided stroke recovery without serious side effects. One study examined a game-based exercise platform for long-term stroke recovery and found no major safety issues.

Although some studies suggest that these robots cannot fully replace traditional therapy, they serve as valuable additional support. Patients can often use these robots safely alongside regular therapy. Overall, research supports the safety of using robot-assisted therapy systems like Rehab CARES for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Rehab CARES system for stroke recovery because it uses robot-assisted therapy, which is a fresh approach compared to the traditional standard of care, like occupational and physical therapy. This system incorporates affordable robots to provide upper limb therapy, potentially making rehabilitation more interactive and engaging through both group and single play sessions. The use of robots may offer more precise, consistent, and repetitive movements than human therapists can provide, which could enhance motor recovery and make therapy sessions more effective.

What evidence suggests that the Rehab CARES system is effective for stroke therapy?

Research has shown that using robots in therapy can aid in recovering movement after a stroke. A review of 13 studies found that this type of therapy improves motor skills. In this trial, participants may receive Robot-Assisted Therapy with the Rehab CARES system, which uses affordable robots to support this promising method. Evidence suggests that robotic therapy, especially when combined with traditional therapy, can also reduce fatigue and improve hand movement. While it may not completely replace regular therapy, it often enhances recovery when used together. Overall, early results are positive about the role of robots in aiding stroke recovery. ^{5 6 7 8 9}

Who Is on the Research Team?

Michelle J Johnson, PhD

Principal Investigator

University of Pennsylvania

Alwyn Johnson, MS

Principal Investigator

Recupero Robotics LLC

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 55 or older, who are more than 3 months post-stroke with hemiplegia. Participants must be able to understand and speak, have mild to moderate arm muscle strength and motor control, and pain levels below severe on the NIH scale. Those with cerebellum lesions from their stroke or severe cognitive issues cannot join.

Inclusion Criteria

I have been diagnosed with a stroke.

It has been over 3 months since my stroke.

I am 55 years old or older.

Exclusion Criteria

I have severe problems with my memory or thinking.

I have no brain damage from a stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care therapy or robot-assisted therapy with Rehab CARES system for upper limb therapy

4 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 follow-up assessments (in-person)

Extension

Potential for further development and testing of the robot gym based on user feedback and outcomes

What Are the Treatments Tested in This Trial?

Interventions

• Rehab CARES system

Trial Overview The study compares standard care against a combination of standard care plus robot-assisted therapy using the Rehab CARES system. This phase 2 trial involves community-based patients performing clinical assessments before and after each treatment approach.

How Is the Trial Designed?

Group I: Robot-Assisted Therapy with Rehab CARES system Experimental Treatment 1 Intervention

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)

Group II: Standard of Care Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

enAble Games LLC

Collaborator

Trials

1

Recruited

40+

Recupero Robotics LLC

Collaborator

Trials

1

Recruited

40+

Mercy Living Independently for Elders (LIFE) - West Philadelphia (Trinity Health Pace)

Collaborator

Trials

1

Recruited

40+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

An extremely low-cost mobile robot was developed to assist in stroke rehabilitation at home, providing cues to improve arm movements and reduce excessive trunk movements, showing stability and accuracy over time.

User feedback indicated that the effectiveness of the robot depends on optimizing the frequency and type of encouragement it provides, which is essential for long-term acceptance and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-cost monitoring of patients during unsupervised robot/computer assisted motivating stroke rehabilitation. Johnson, MJ., Shakya, Y., Strachota, E., et al.[2016]

Robot-aided rehabilitation for stroke patients offers a more intensive and engaging approach to restoring arm function, making repetitive exercises feel like games, which can enhance motivation and adherence to therapy.

The review highlights the effectiveness of various rehabilitation robots, showing positive clinical outcomes and usability in real-life applications, indicating their potential to significantly improve recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of technological and clinical aspects of robot-aided rehabilitation of upper-extremity after stroke. Babaiasl, M., Mahdioun, SH., Jaryani, P., et al.[2017]

Robot-assisted therapy (RAT) significantly improves upper limb motor control and activity function in post-stroke patients compared to non-robotic therapy, with notable effects observed in the Fugl-Meyer Upper Extremity assessment and activity function after more than 15 hours of training.

However, the benefits of RAT are not sustained long-term, and its effectiveness is reduced in patients with severe impairments or those receiving passive training, indicating that active participation is crucial for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short and long-term effects of robot-assisted therapy on upper limb motor function and activity of daily living in patients post-stroke: a meta-analysis of randomized controlled trials. Zhang, L., Jia, G., Ma, J., et al.[2022]

Robotic assistance systems in early neurological rehabilitation are viewed positively by professionals, with the potential to relieve the workload of healthcare employees, enhancing their ability to provide care.

The study, which involved interviews with nine experts from three clinics, supports the idea that robotic systems can significantly benefit patient mobilization and rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chances and Risks of Using Robotic Assistance Systems in Early Neurological Rehabilitation: A Qualitative Analysis. Waibel, AK., Holl, F., Swoboda, W., et al.[2022]

A robotic rehabilitation intervention using fully assisted reaching and hand-to-mouth movements showed significant functional improvements in 9 out of 10 chronic stroke patients after just 12 sessions over one month, as measured by the Fugl-Meyer Assessment.

The study suggests that this approach can effectively promote upper-limb function even in patients who are significantly impaired, indicating potential for broader application in subacute stroke and other neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using robot fully assisted functional movements in upper-limb rehabilitation of chronic stroke patients: preliminary results. Caimmi, M., Chiavenna, A., Scano, A., et al.[2018]

A new robot-assisted therapy platform for hand rehabilitation after stroke allows patients to train with minimal therapist supervision, enabling more therapy sessions and potentially improving hand function.

In a preliminary usability study with 10 chronic stroke participants, the platform was found to be user-friendly, with participants able to perform therapy independently 86.54% of the time after a brief familiarization, indicating its potential for real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards a Platform for Robot-Assisted Minimally-Supervised Therapy of Hand Function: Design and Pilot Usability Evaluation. Ranzani, R., Eicher, L., Viggiano, F., et al.[2022]

Robot-assisted therapy (RT) significantly improved upper limb motor function and daily living activities in sub-acute stroke patients compared to conventional rehabilitation (CR), as shown by various assessments over a 2-week period.

Both RT and CR groups showed improvements, but the RT group had notably better outcomes in motor function and daily activities at both the 2-week and 1-month follow-ups, indicating that RT can be an effective rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of short-term upper limb robot-assisted therapy on the rehabilitation of sub-acute stroke patients. Jiang, S., You, H., Zhao, W., et al.[2021]

Upper limb robot-assisted rehabilitation has been shown to be well-tolerated and effective in reducing motor impairments in hemiparetic patients, particularly after stroke, with significant improvements noted in both acute and chronic stages.

The potential for increased access to rehabilitation robots could enhance the effectiveness of treatment for patients with upper limb disabilities, suggesting a promising future for this technology in rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does upper limb robot-assisted rehabilitation contribute to improve the prognosis of post-stroke hemiparesis?]. Duret, C., Gracies, JM.[2016]

This systematic review and meta-analysis included eight randomized clinical trials and found no significant improvement in upper-limb motor function or activity when noninvasive brain stimulation (NIBS) was added to robot-assisted therapy for stroke rehabilitation.

The results indicated that there is currently insufficient evidence to support the effectiveness of NIBS as an adjunct to robotic therapy in enhancing recovery outcomes for individuals with stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Robotic Therapy Associated With Noninvasive Brain Stimulation on Upper-Limb Rehabilitation After Stroke: Systematic Review and Meta-analysis of Randomized Clinical Trials. Reis, SB., Bernardo, WM., Oshiro, CA., et al.[2021]

Robot-assisted therapy for the paretic upper limb (RT-UL) after a stroke shows small but significant improvements in motor control and muscle strength, based on a systematic review of 44 randomized controlled trials involving 1362 participants, with no serious adverse events reported.

While RT-UL is safe and allows for increased practice intensity, the overall effects on upper limb capacity and daily activities are limited, suggesting that the therapy's benefits may be specific to the joints targeted and that further research is needed to optimize treatment design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Robot-Assisted Therapy for the Upper Limb After Stroke. Veerbeek, JM., Langbroek-Amersfoort, AC., van Wegen, EE., et al.[2022]

The study investigates the feasibility of using an active rehabilitation robot for unsupervised therapy in stroke patients, with 13 participants completing a 4-week intervention without any reported adverse events, indicating a safe approach to increasing therapy dose.

The research aims to establish a systematic method for transitioning from supervised to unsupervised rehabilitation, which could enhance therapy delivery in clinical settings and potentially allow for home-based rehabilitation after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study. Devittori, G., Ranzani, R., Dinacci, D., et al.[2023]

A clinical trial with 20 stroke patients demonstrated that robot-aided rehabilitation therapy is safe and well-tolerated, showing no adverse effects during the procedure.

The study suggests that manipulating the impaired limb with robotic assistance may positively influence brain recovery, highlighting the potential benefits of integrating robotics into neurorehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-aided neurorehabilitation. Krebs, HI., Hogan, N., Aisen, ML., et al.[2022]

A novel post-stroke therapy using haptics and graphics in a large VR system aims to enhance recovery by creating an environment that encourages learning through error, rather than minimizing it.

The therapy involves collaboration between the patient, therapist, and technology, suggesting a comprehensive approach to rehabilitation that could lead to accelerated recovery for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist-mediated post-stroke rehabilitation using haptic/graphic error augmentation. Rozario, SV., Housman, S., Kovic, M., et al.[2021]

Robotic devices for movement therapy are advancing towards commercial availability, promising to enhance stroke rehabilitation by extending therapy programs and providing new measures of patient impairment.

Research supports the clinical value of these robotic systems, although challenges remain in achieving acceptance and practical implementation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic devices for movement therapy after stroke: current status and challenges to clinical acceptance. Lum, P., Reinkensmeyer, D., Mahoney, R., et al.[2003]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3859002/

Robot-assisted Therapy in Stroke Rehabilitation - PMC These results indicate that the robot-assisted therapy with end-effector-type devices cannot replace conventional therapy in patients with chronic stroke.

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/2055668317708732

From Theradrive to Rehab CARES, a compact robot gym This paper describes the evolution of an approach to the implementation of affordable, technology-assisted stroke rehabilitation which relies on ...

3. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1622661/full

Systematic review and meta-analysis of effectiveness ... This meta-analysis of 13 randomized controlled trials provides consistent evidence that robotic-assisted therapy improves motor recovery in post-stroke patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0967586825004187

The impact of robotic hand rehabilitation on hand function ... This study suggests that robotic hand treatment with Amadeo®, combined with traditional methods, reduces fatigue in stroke patients with hand impairments.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10624545/

Effectiveness of Robotics in Stroke Rehabilitation to ... Current evidence suggests that the use of RAT along with CT may accelerate upper extremity recovery, measured by FMA, in the beginning of rehabilitation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6453086/

Affordable stroke therapy in high-, low- and middle-income ... This paper describes the evolution of an approach to the implementation of affordable, technology-assisted stroke rehabilitation which relies on low-cost ...

7. researchgate.net researchgate.net/publication/317294389_Affordable_stroke_therapy_in_high-_low-_and_middle-income_countries_From_Theradrive_to_Rehab_CARES_a_compact_robot_gym

From Theradrive to Rehab CARES, a compact robot gym This paper describes the evolution of an approach to the implementation of affordable, technology-assisted stroke rehabilitation which relies on low-cost ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00915-2

A robot goes to rehab: a novel gamified system for long-term ... We describe a robot-based gamified exercise platform, which we developed for long-term post-stroke rehabilitation.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2667241325000047

Rehab-Bot: A home-based lower-extremity rehabilitation ... This paper presents a proof-of-concept for a lower-extremity rehabilitation device, called Rehab-bot, that would aid patients with lower-limb impairments.