Robot-assisted Training with the H2 Exoskeleton for Stroke
(H2-NeuroExo Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byJose L Pons, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Houston
Disqualifiers: Severe cognitive, visual, sensory deficits, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
26789How 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.
12101112Eligibility Criteria
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 are between 18 and 75 years old.
You have mild to moderate difficulty with daily activities after a stroke.
+7 more
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.
+6 more
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Robot-assisted RehabilitationExperimental Treatment1 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 practiceActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of HoustonHouston, TX
TIRR Memorial Hermann HospitalHouston, TX
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Who Is Running the Clinical Trial?
University of HoustonLead Sponsor
TIRR Memorial HermannCollaborator
The University of Texas Health Science Center, HoustonCollaborator
References
Therapeutic Effects of Robotic-Exoskeleton-Assisted Gait Rehabilitation and Predictive Factors of Significant Improvements in Stroke Patients: A Randomized Controlled Trial. [2023]Robotic-exoskeleton-assisted gait rehabilitation improves lower limb strength and functions in post-stroke patients. However, the predicting factors of significant improvement are unclear. We recruited 38 post-stroke hemiparetic patients whose stroke onsets were
The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. [2022]Stroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors.
Effects of Training with a Powered Exoskeleton on Cortical Activity Modulation in Hemiparetic Chronic Stroke Patients: A Randomized Controlled Pilot Trial. [2023]To investigate the effects of exoskeleton-assisted gait training in stroke patients.
Intensity Modulated Exoskeleton Gait Training Post Stroke. [2023]Stroke is a leading cause of long-term disability. While major advances have been made in early intervention for the treatment of patients post stroke, the majority of survivors have residual mobility challenges. Recovery of motor function is dependent on the interrelationship between dosing, intensity, and task specific practice applied during rehabilitation. Robotic exoskeleton (RE) based gait training utilizes progressive repetitive task-oriented movements to promote functional recovery. The purpose of this investigation was to demonstrate the utilization of intensity modulated exoskeleton gait training on functional outcomes and walking speed post stoke. Preliminary data is presented for individuals diagnosed with stroke who received RE gait training. The intensity modulated RE gait training was delivered by a physical therapist and participants trained at 75-85% of calculated max heart rates at each session, over 10 weeks (30 sessions). After 10 weeks of training participants increased walking speed (10 meter walk test) and functional measures (timed up and go, berg balance assessment, dynamic gait index and functional ambulation category). These preliminary results demonstrate the utilization of intensity modulated gait training for improved functional ambulation and motor recovery using a robotic exoskeleton overground gait training post stroke.Clinical Relevance- Preliminary data provides initial evidence for intensity modulated exoskeleton gait training as a therapeutic intervention post stroke. More research is needed to demonstrate the potential relationships between intensity based gait training, exoskeletons and improved functional ambulation in post stroke rehabilitation.
Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]Powered robotic exoskeletons are a potential intervention for gait rehabilitation in stroke to enable repetitive walking practice to maximize neural recovery. As this is a relatively new technology for stroke, a scoping review can help guide current research and propose recommendations for advancing the research development. The aim of this scoping review was to map the current literature surrounding the use of robotic exoskeletons for gait rehabilitation in adults post-stroke. Five databases (Pubmed, OVID MEDLINE, CINAHL, Embase, Cochrane Central Register of Clinical Trials) were searched for articles from inception to October 2015. Reference lists of included articles were reviewed to identify additional studies. Articles were included if they utilized a robotic exoskeleton as a gait training intervention for adult stroke survivors and reported walking outcome measures. Of 441 records identified, 11 studies, all published within the last five years, involving 216 participants met the inclusion criteria. The study designs ranged from pre-post clinical studies (n = 7) to controlled trials (n = 4); five of the studies utilized a robotic exoskeleton device unilaterally, while six used a bilateral design. Participants ranged from sub-acute (6 months) stroke. Training periods ranged from single-session to 8-week interventions. Main walking outcome measures were gait speed, Timed Up and Go, 6-min Walk Test, and the Functional Ambulation Category. Meaningful improvement with exoskeleton-based gait training was more apparent in sub-acute stroke compared to chronic stroke. Two of the four controlled trials showed no greater improvement in any walking outcomes compared to a control group in chronic stroke. In conclusion, clinical trials demonstrate that powered robotic exoskeletons can be used safely as a gait training intervention for stroke. Preliminary findings suggest that exoskeletal gait training is equivalent to traditional therapy for chronic stroke patients, while sub-acute patients may experience added benefit from exoskeletal gait training. Efforts should be invested in designing rigorous, appropriately powered controlled trials before powered exoskeletons can be translated into a clinical tool for gait rehabilitation post-stroke.
Risk management and regulations for lower limb medical exoskeletons: a review. [2020]Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human-machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals with gait disabilities to safely and independently ambulate.
Gait training of subacute stroke patients using a hybrid assistive limb: a pilot study. [2017]Purpose To determine whether gait training with a hybrid assistive limb (HAL) as an exoskeleton robotic device was safe and could increase functional mobility and gait ability in subacute stroke patients. Methods The participants were eight patients with post-stroke hemiparesis whose walking impairment and gait recovery curves had plateaued. The intervention program was gait training using HAL and a walker for 20 min daily 5 days a week for 5 weeks. The 10-m maximum walking speed (MWS), self-selected walking speed (SWS) and 2-min-walk test (2MT) without HAL were used as primary outcome measures to determine the effects of training. The Berg Balance Scale (BBS), Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) and functional ambulation category (FAC) were assessed as secondary outcomes. These measures were assessed before and after the 5-week intervention program and were analyzed statistically using a paired t-test. Results All eight participants completed the intervention program with no adverse events. There were significant increases in MWS, SWS and 2MT. BBS, FMA and FAC also increased, but not significantly. Conclusion The new HAL exoskeleton robotic device was efficient and safe for improving motor function and gait in patients in the subacute stage after stroke. Implications for Rehabilitation Gait training using HAL will improve gait ability of individuals with post stroke. The HAL achieve intensive gait training without increase spasticity and abnormal gait pattern.
Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. [2022]Intensive task specific training early after stroke may enhance beneficial neuroplasticity and functional recovery. Impaired gait after hemiparetic stroke remains a challenge that may be approached early after stroke by use of novel technology. The aim of the study was to investigate the safety and feasibility of the exoskeleton Hybrid Assistive Limb (HAL) for intensive gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely impaired gait early after stroke.
Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]Robot-assisted gait training (RAGT) devices are used in rehabilitation to improve patients' walking function. While there are some reports on the adverse events (AEs) and associated risks in overground exoskeletons, the risks of stationary gait trainers cannot be accurately assessed. We therefore aimed to collect information on AEs occurring during the use of stationary gait robots and identify associated risks, as well as gaps and needs, for safe use of these devices. We searched both bibliographic and full-text literature databases for peer-reviewed articles describing the outcomes of stationary RAGT and specifically mentioning AEs. We then compiled information on the occurrence and types of AEs and on the quality of AE reporting. Based on this, we analyzed the risks of RAGT in stationary gait robots. We included 50 studies involving 985 subjects and found reports of AEs in 18 of those studies. Many of the AE reports were incomplete or did not include sufficient detail on different aspects, such as severity or patient characteristics, which hinders the precise counts of AE-related information. Over 169 device-related AEs experienced by between 79 and 124 patients were reported. Soft tissue-related AEs occurred most frequently and were mostly reported in end-effector-type devices. Musculoskeletal AEs had the second highest prevalence and occurred mainly in exoskeleton-type devices. We further identified physiological AEs including blood pressure changes that occurred in both exoskeleton-type and end-effector-type devices. Training in stationary gait robots can cause injuries or discomfort to the skin, underlying tissue, and musculoskeletal system, as well as unwanted blood pressure changes. The underlying risks for the most prevalent injury types include excessive pressure and shear at the interface between robot and human (cuffs/harness), as well as increased moments and forces applied to the musculoskeletal system likely caused by misalignments (between joint axes of robot and human). There is a need for more structured and complete recording and dissemination of AEs related to robotic gait training to increase knowledge on risks. With this information, appropriate mitigation strategies can and should be developed and implemented in RAGT devices to increase their safety.
Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. [2021]Wearable ankle robotics could potentially facilitate intensive repetitive task-specific gait training on stair environment for stroke rehabilitation. A lightweight (0.5 kg) and portable exoskeleton ankle robot was designed to facilitate over-ground and stair training either providing active assistance to move paretic ankle augmenting residual motor function (power-assisted ankle robot, PAAR), or passively support dropped foot by lock/release ankle joint for foot clearance in swing phase (swing-controlled ankle robot, SCAR). In this two-center randomized controlled trial, we hypothesized that conventional training integrated with robot-assisted gait training using either PAAR or SCAR in stair environment are more effective to enhance gait recovery and promote independency in early stroke, than conventional training alone.
Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists. [2020]Wearable powered exoskeletons are a new and emerging technology developed to provide sensory-guided motorized lower limb assistance enabling intensive task specific locomotor training utilizing typical lower limb movement patterns for persons with gait impairments. To ensure that devices meet end-user needs it is important to understand and incorporate end-users perspectives, however research in this area is extremely limited in the post-stroke population. The purpose of this study was to explore in-depth, end-users perspectives, persons with stroke and physiotherapists, following a single-use session with a H2 exoskeleton.
Brief exosuit use improves post-stroke gait. [2023]After only 2 weeks of training with an exoskeleton suit, post-stroke individuals improved their knee flexion and gait.