Robotic Rehabilitation for Stroke

(Aim2&3 Trial)

Overseen By Soh-Hyun Hur

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Apraxia, Severe pain, Severe contracture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests robotic rehabilitation tools to help people regain arm and hand movement after a stroke. It examines whether training specific parts of the arm or hand, combined with passive stretching, improves recovery. Participants will use either a hand robot (robot-assisted therapy) or IntelliArm (robot-aided rehabilitation) for exercises. The trial is ideal for those who experienced a single stroke within the last year and have noticeable arm or hand movement issues. As an unphased trial, it offers a unique opportunity to contribute to innovative rehabilitation research that could enhance recovery options for future stroke patients.

Do I need to stop my current medications for the trial?

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

What prior data suggests that these robotic rehabilitation methods are safe for stroke patients?

Research has shown that using robots for hand weakness after a stroke is safe. In studies, patients handled the hand robot well, and no problems were reported, indicating its safety for therapy.

Similarly, research on the IntelliArm indicates that robot-assisted therapy for arm movements after a stroke is well-received. Studies have not found any major side effects, suggesting this treatment is generally safe for patients.

Both the hand robot and IntelliArm are designed to aid recovery after a stroke. The evidence so far shows they are safe options to consider for those thinking about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these robotic rehabilitation treatments for stroke recovery because they offer a personalized approach to physical therapy. Unlike traditional methods, which often rely on manual exercises and therapist guidance, these robotic systems—like the hand robot and IntelliArm—provide consistent, controlled passive and active movements. This technology allows for more precise targeting of either the arm or hand, adapting to the patient's needs. Additionally, the integration of both passive stretching and active movement training within a single session enhances the potential for improved motor recovery, potentially speeding up the rehabilitation process.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

Research has shown that robotic rehabilitation can improve movement and muscle strength after a stroke. In this trial, participants will join different treatment arms involving either the hand robot or the IntelliArm. Studies indicate that using the hand robot alongside regular therapy significantly aids hand recovery and reduces tiredness. The IntelliArm enhances movement and muscle strength through robotic therapy. Both devices facilitate neuroplasticity, helping the brain rewire itself to improve movement. Although not all studies agree on the extent of improvement, many suggest that these robotic treatments could help stroke survivors regain movement in their arms and hands. ^{2 3 6 7 8}

Who Is on the Research Team?

Li-Qun Zhang, Ph.D.

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for individuals who had their first stroke 1-12 months ago, can sit for 3 hours, and have an arm and hand recovery stage rated between 2-4. It's not suitable for those with severe pain or contracture in the upper extremity, apraxia, low mental status scores, recent Botox in the arm, or involvement in other gait/limb studies.

Inclusion Criteria

I have had one stroke, either from a clot or bleed.

My arm and hand recovery after stroke is rated between stages 2 to 4.

I had a stroke between 1 and 12 months ago.

Exclusion Criteria

I rate my shoulder pain as 7 or more out of 10.

I have severe stiffness in my arm that limits movement.

I have not had a Botox injection in my arm in the last 4 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robot-aided rehabilitation with either the IntelliArm or hand robot, involving passive stretching or movement followed by active therapy

8 weeks

Multiple sessions per week

Follow-up

Participants are monitored for changes in motor function and other outcomes post-treatment

2 months

Assessments at 2 weeks and 2 months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Hand robot
• IntelliArm
• Passive movement
• Passive stretching

Trial Overview

The study aims to assess and treat complex motor impairments of the arm and hand post-stroke. It will compare effects of different treatments: passive movement using a Hand robot or IntelliArm device versus passive stretching exercises on limb function recovery.

How Is the Trial Designed?

Group I: The hand robot with passive stretching Experimental Treatment 2 Interventions

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.

Group II: The hand robot with passive movement Experimental Treatment 2 Interventions

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.

Group III: IntelliArm with passive stretching Experimental Treatment 2 Interventions

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.

Group IV: IntelliArm with passive movement Experimental Treatment 2 Interventions

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

North Carolina State University

Collaborator

Trials

38

Recruited

50,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

New electronic hand rehabilitation devices can be locally assembled at low cost and provide effective feedback for patients during their recovery process.

Devices like electrogoniometers and pressure-sensitive tools can be utilized to monitor hand and wrist movement, enhancing the rehabilitation experience and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic training devices for hand rehabilitation. Morris, AF., Brown, M.[2012]

The RobHand robotic exoskeleton is a safe rehabilitation tool for stroke patients, with no significant adverse events reported during the training sessions, and users expressed high satisfaction with its comfort and professional support.

Despite the positive safety and satisfaction outcomes, the study found no statistically significant improvements in manual function after 16 training sessions, likely due to the chronic stage of the stroke in the participants, suggesting that future research should focus on earlier intervention in subacute patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. Barria, P., Riquelme, M., Reppich, H., et al.[2023]

The article proposes a uniform approach for assessing the safety of rehabilitation robots early in their development, focusing on safety skills that help mitigate specific risks during human-robot interactions.

Identifying excessive forces on soft tissue and musculoskeletal levels as key hazards, the authors suggest safety validation protocols that can be adapted across various applications, highlighting the need for reliable measurement methods and limit values for safe human-robot interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Assessment of Rehabilitation Robots: A Review Identifying Safety Skills and Current Knowledge Gaps. Bessler, J., Prange-Lasonder, GB., Schaake, L., et al.[2021]

A four-week robot-assisted rehabilitation program significantly improved hand function in stroke patients, with greater benefits observed in those receiving continuous active therapy compared to those who had a mix of passive and active therapy.

Both treatment groups showed improvements in various hand function assessments, but the full-term intervention group demonstrated superior results, indicating that longer active therapy leads to better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy. Hwang, CH., Seong, JW., Son, DS.[2016]

A new validation toolkit was created to ensure the safety of rehabilitation robots by assessing risks related to moving a patient's upper limb beyond safe anatomical limits.

The toolkit includes a sensorized dummy limb and software for risk assessment, allowing for better monitoring of rehabilitation robots during operation to prevent injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Limit Range of Motion Safety Function of Upper Limb Rehabilitation Robots with an Anthropometrically Adjustable and Sensorized Dummy Limb. Toth, A., Pilissy, T., Bauer, MO., et al.[2022]

In a study of 32 stroke patients with hand paralysis, robot-assisted mobilization combined with traditional physiotherapy and occupational therapy significantly improved outcomes such as the National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) after 3 weeks of treatment.

The experimental group using the robotic device Gloreha experienced a greater reduction in pain (11.3 mm) compared to the control group (3.7 mm) on a visual analog scale, indicating that robot-assisted therapy can enhance pain management in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial. Villafañe, JH., Taveggia, G., Galeri, S., et al.[2019]

A new robotic hand rehabilitation device was developed that allows for full finger motion and easy setup, making it user-friendly for stroke patients needing sensorimotor rehabilitation.

In tests with healthy participants, the device demonstrated low interaction forces (1.37 N), indicating a smooth and effective user experience, which could enhance clinical acceptance and effectiveness in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Clinical-Driven Design for Robotic Hand Rehabilitation: Combining Sensory Training, Effortless Setup, and Large Range of Motion in a Palmar Device. Rätz, R., Conti, F., Müri, RM., et al.[2023]

Robot-assisted therapy for stroke rehabilitation has been shown to improve motor and functional abilities of the upper limb, as well as reduce hemispatial neglect, based on a review of six randomized controlled trials.

This therapy allows for increased repetitions of specific movements, which is beneficial across all phases of stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hand robotic devices in neurorehabilitation: A systematic review on the feasibility and effectiveness of stroke rehabilitation]. Hernández Echarren, A., Sánchez Cabeza, Á.[2023]

Robot-assisted rehabilitation devices, such as the MIT-Manus and Mirror-Image Motion Enabler, have shown superior effectiveness in improving motor function for stroke and brain-injured patients compared to traditional therapy methods.

The electromechanical gait trainer GT I has been proven effective for gait rehabilitation after stroke, outperforming conventional treadmill training, while the Lokomat reduces the effort required for therapy in spinal cord-injured patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper and lower extremity robotic devices for rehabilitation and for studying motor control. Hesse, S., Schmidt, H., Werner, C., et al.[2022]

Robotic-aided hand physiotherapy, including brain-machine interfaces, shows promise in improving recovery outcomes for stroke patients, with a review of 110 devices highlighting advancements in personalized and at-home treatment options.

The integration of these robotic rehabilitation systems into healthcare presents challenges, but the evidence supporting their efficacy suggests they could significantly enhance physiotherapy practices for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic devices and brain-machine interfaces for hand rehabilitation post-stroke. McConnell, AC., Moioli, RC., Brasil, FL., et al.[2018]

In a study involving 45 patients with acute stroke, upper-limb robotic-assisted therapy (RAT) combined with conventional therapy showed greater improvements in gross manual dexterity, upper-limb functional ability, and social participation compared to conventional therapy alone after 6 months.

RAT was implemented as a partial substitution for conventional therapy, with both groups receiving treatment for 9 weeks, demonstrating that integrating robotic assistance can enhance rehabilitation outcomes in the early phase of stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of upper-limb robotic-assisted therapy in the early rehabilitation phase after stroke: A single-blind, randomised, controlled trial. Dehem, S., Gilliaux, M., Stoquart, G., et al.[2020]

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