Robot-Assisted Therapy for Stroke

Recruiting at1 trial location

Overseen by Alwyn Johnson, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Cerebellum lesions, severe cognitive, others

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new rehabilitation method for stroke patients using simple robots that help with exercises. The robots provide feedback and can be used alone or in groups to play therapy games. The goal is to see if this method is as effective as traditional therapy and if it can make quality care more accessible in community settings. Robots were introduced in rehabilitation in the 90s to reduce the physical effort of therapists.

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 data supports the effectiveness of the treatment Rehab CARES system, Robot-assisted therapy with simple force-feedback robots for stroke?

Research shows that robot-assisted therapy can help stroke patients by improving movement in the affected limb and supporting brain recovery. Studies indicate that this type of therapy is well-tolerated by patients and does not have negative side effects. ^{1 2 3 4 5}

Is robot-assisted therapy generally safe for humans?

The research suggests that robot-assisted therapy is generally well-received and stable, with no significant safety concerns reported. It is seen as a promising tool for rehabilitation, especially in stroke patients, and is considered safe for use in both supervised and unsupervised settings. ^{4 6 7 8 9}

How is robot-assisted therapy different from other treatments for stroke?

Robot-assisted therapy for stroke is unique because it uses robots to provide intensive, repetitive, and engaging exercises that can be more motivating than traditional methods. This therapy can also offer precise measurements of progress, helping to tailor the rehabilitation process to each patient's needs. ^{10 11 12 13 14}

Research Team

Michelle J Johnson, PhD

Principal Investigator

University of Pennsylvania

Alwyn Johnson, MS

Principal Investigator

Recupero Robotics LLC

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Rehab CARES system (Robotic Exercise 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.

Participant Groups

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+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

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+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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-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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Robot-aided neurorehabilitation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Therapist-mediated post-stroke rehabilitation using haptic/graphic error augmentation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Robot-Assisted Therapy for the Upper Limb After Stroke. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Chances and Risks of Using Robotic Assistance Systems in Early Neurological Rehabilitation: A Qualitative Analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Robotic devices for movement therapy after stroke: current status and challenges to clinical acceptance. [2003]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of short-term upper limb robot-assisted therapy on the rehabilitation of sub-acute stroke patients. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Low-cost monitoring of patients during unsupervised robot/computer assisted motivating stroke rehabilitation. [2016]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Towards a Platform for Robot-Assisted Minimally-Supervised Therapy of Hand Function: Design and Pilot Usability Evaluation. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Using robot fully assisted functional movements in upper-limb rehabilitation of chronic stroke patients: preliminary results. [2018]

11. France pubmed.ncbi.nlm.nih.gov

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

12. United States 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. [2021]

13. England pubmed.ncbi.nlm.nih.gov

A review of technological and clinical aspects of robot-aided rehabilitation of upper-extremity after stroke. [2017]

14. England 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. [2022]