Robot-assisted Training with the H2 Exoskeleton for Stroke

(H2-NeuroExo Trial)

Recruiting at 1 trial location

Overseen By Gerard E Francisco, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Disqualifiers: Severe cognitive, visual, sensory deficits, others

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

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

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the H2 Exoskeleton safe for use in humans?

The H2 Exoskeleton has been evaluated for gait rehabilitation in stroke survivors, and while specific safety data for the H2 is not detailed, similar devices like the Hybrid Assistive Limb (HAL) have been found safe with no adverse events reported in studies. However, general risks for exoskeletons include skin and tissue discomfort, musculoskeletal issues, and blood pressure changes, highlighting the need for careful monitoring and risk management. ^{1 2 3 4 5}

How is the H2 Exoskeleton treatment different from other stroke rehabilitation treatments?

The H2 Exoskeleton is a novel robotic device designed to assist with gait rehabilitation in stroke survivors by providing motorized lower limb assistance, which can enhance recovery by enabling intensive, task-specific training that mimics natural movement patterns. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment H2 Lower Limb Exoskeleton for stroke rehabilitation?

Research shows that robotic exoskeletons, like the H2, can help improve walking ability in stroke patients by providing repetitive walking practice, which is important for recovery. Studies suggest that these devices are especially beneficial for patients in the early stages of recovery, helping them walk faster and improve their balance. ^{1 9 10 11 12}

Who Is on the Research Team?

Jose L Pons, PhD

Principal Investigator

Spanish Research Council

Gerard E Francisco, MD

Principal Investigator

TIRR Memorial Hermann Hospital

Jose L Contreras-Vidal, PhD

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who've had a stroke at least 3 months ago, can stand and walk with assistance, have mild to moderate disability, normal cognitive ability (score >24 on Mini Mental State Exam), and controlled muscle stiffness. It's not for those with severe cognitive/visual deficits, other medical issues preventing rehab, severe sensory loss or joint contractures affecting walking.

Inclusion Criteria

You do not have any skin problems or wounds.

You have mild to moderate difficulty with daily activities after a stroke.

Able to understand and sign the consent form

Exclusion Criteria

You have serious problems with memory or thinking, or with your vision.

You have other medical conditions that would make it difficult for you to have regular rehabilitation.

You have a condition where you may ignore one side of your body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either supervised motor practice or robot-assisted training with the H2 lower limb powered exoskeleton for 4 weeks, with 3 sessions per week, each lasting about 1.5 hours

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2 weeks and 2 months post-intervention

2 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• H2 Lower Limb Exoskeleton

Trial Overview The study tests a smart robotic exoskeleton against supervised motor practice in post-stroke rehabilitation. It also examines brain wave patterns via EEG to potentially control orthotic devices by thought for improved human-robot interaction in walking assistance.

How Is the Trial Designed?

Group I: Robot-assisted Rehabilitation Experimental Treatment 1 Intervention

Participants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours.

Group II: Supervised motor practice Active Control 1 Intervention

Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

TIRR Memorial Hermann

Collaborator

Trials

16

Recruited

4,700+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 38 post-stroke patients, those who received robotic-exoskeleton-assisted rehabilitation showed significantly greater improvements in knee flexion torque, walking distance, and quality of life compared to those receiving standard rehabilitation alone.

Robotic training was identified as the strongest predictor of improvement in walking speed and overall health-related quality of life, highlighting its effectiveness in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Robotic-Exoskeleton-Assisted Gait Rehabilitation and Predictive Factors of Significant Improvements in Stroke Patients: A Randomized Controlled Trial. Lee, YH., Ko, LW., Hsu, CY., et al.[2023]

The H2 robotic exoskeleton was evaluated in a small study with 3 hemiparetic stroke patients over 4 weeks, demonstrating safety and ease of use without any adverse events reported.

This novel device allows for intensive overground gait training, showing promise for enhancing rehabilitation efforts and engaging patients actively in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. Bortole, M., Venkatakrishnan, A., Zhu, F., et al.[2022]

Exoskeleton-assisted gait training using the Healbot G significantly increased cortical activity in stroke patients compared to traditional treadmill training, indicating enhanced brain engagement during rehabilitation.

Patients in the Healbot G group showed significant improvements in walking ability, balance, and lower limb strength, demonstrating the efficacy of exoskeleton training in enhancing recovery post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Training with a Powered Exoskeleton on Cortical Activity Modulation in Hemiparetic Chronic Stroke Patients: A Randomized Controlled Pilot Trial. Yoo, M., Chun, MH., Hong, GR., et al.[2023]

Intensity modulated robotic exoskeleton gait training significantly improved walking speed and functional mobility in stroke survivors over a 10-week period, with participants training at 75-85% of their maximum heart rates during 30 sessions.

These preliminary results suggest that using robotic exoskeletons for gait training can enhance motor recovery and functional ambulation in post-stroke rehabilitation, although further research is needed to fully understand the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity Modulated Exoskeleton Gait Training Post Stroke. Nolan, KJ., Ames, GR., Dandola, CM., et al.[2023]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Gait training with the hybrid assistive limb (HAL) exoskeleton was safe and effective for improving walking speed and distance in eight subacute stroke patients over a 5-week program, with no adverse events reported.

Participants showed significant improvements in maximum walking speed, self-selected walking speed, and 2-minute walk test results, indicating enhanced functional mobility without increasing spasticity or abnormal gait patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training of subacute stroke patients using a hybrid assistive limb: a pilot study. Mizukami, M., Yoshikawa, K., Kawamoto, H., et al.[2017]

The Hybrid Assistive Limb (HAL) exoskeleton is safe and feasible for intensive gait training in hemiparetic stroke patients, with no serious adverse events reported during the study involving 8 patients within 7 weeks post-stroke.

All participants showed significant improvements in walking ability, as evidenced by a reduction in the 10 Meter Walking Test time from a median of 111.5 seconds to 40 seconds, and an increase in the Functional Ambulation Categories score from 0 to 1.5.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. Nilsson, A., Vreede, KS., Häglund, V., et al.[2022]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

In a study involving sub-acute stroke survivors, integrating robot-assisted gait training with conventional training significantly improved gait recovery, with the swing-controlled ankle robot (SCAR) leading to a higher percentage of independent walkers (56%) compared to conventional training alone (29%).

The power-assisted ankle robot (PAAR) was found to enhance walking speed more effectively than SCAR, indicating that active powered assistance can help users walk faster and more efficiently with their affected leg during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. Yeung, LF., Lau, CCY., Lai, CWK., et al.[2021]

The study involved five post-stroke individuals and six physiotherapists who provided valuable insights after a 1.5-hour session with the H2 exoskeleton, highlighting the importance of user perspectives in the design and functionality of rehabilitation technologies.

Key themes identified included the need for collaboration between developers and users, concerns about device usability, and the potential for exoskeletons to enhance walking ability, indicating a strong interest in this technology for improving post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists. Vaughan-Graham, J., Brooks, D., Rose, L., et al.[2020]

Post-stroke individuals showed significant improvements in knee flexion and walking ability after just 2 weeks of training with an exoskeleton suit.

The use of the exoskeleton suit demonstrates potential as an effective rehabilitation tool for enhancing mobility in individuals recovering from a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief exosuit use improves post-stroke gait. Yashinski, M.[2023]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Robotic-Exoskeleton-Assisted Gait Rehabilitation and Predictive Factors of Significant Improvements in Stroke Patients: A Randomized Controlled Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. [2022]

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

Effects of Training with a Powered Exoskeleton on Cortical Activity Modulation in Hemiparetic Chronic Stroke Patients: A Randomized Controlled Pilot Trial. [2023]

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

Intensity Modulated Exoskeleton Gait Training Post Stroke. [2023]

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

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Gait training of subacute stroke patients using a hybrid assistive limb: a pilot study. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. [2021]

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

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists. [2020]

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

Brief exosuit use improves post-stroke gait. [2023]