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

Trial Summary

What is the purpose of this trial?

Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.

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 data supports the effectiveness of the treatment Hand robot therapy for stroke rehabilitation?

Research shows that robot-assisted hand therapy can help improve movement and function in the arms and hands of stroke patients. It is often as effective, or even more effective, than traditional therapy, especially when used early in the rehabilitation process. ^{1 2 3 4 5}

Is robotic rehabilitation for stroke generally safe for humans?

Research on robotic rehabilitation devices, like the RobHand exoskeleton, shows they are generally safe for humans, with no significant adverse events reported, such as skin lesions or fatigue. Safety assessments of rehabilitation robots focus on preventing excessive forces on the body, and current studies suggest these devices are safe when used correctly. ^{6 7 8 9 10}

How is the IntelliArm treatment different from other stroke rehabilitation treatments?

The IntelliArm treatment is unique because it uses a robotic device to assist with hand movements, allowing for more repetitions of specific tasks, which can lead to better motor and functional improvements in the upper limb compared to traditional therapies. This robot-assisted therapy can be personalized and used at home, making it a flexible option for stroke rehabilitation. ^{1 2 3 4 11}

Research Team

Li-Qun Zhang, Ph.D.

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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 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 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]

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 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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Hand robotic devices in neurorehabilitation: A systematic review on the feasibility and effectiveness of stroke rehabilitation]. [2023]

2. Netherlands 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. [2020]

3. Sweden pubmed.ncbi.nlm.nih.gov

Robotic devices and brain-machine interfaces for hand rehabilitation post-stroke. [2018]

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

Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial. [2019]

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

Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. [2023]

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

Electronic training devices for hand rehabilitation. [2012]

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

Safety Assessment of Rehabilitation Robots: A Review Identifying Safety Skills and Current Knowledge Gaps. [2021]

9. United States 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. [2022]

10. Switzerland 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Upper and lower extremity robotic devices for rehabilitation and for studying motor control. [2022]