Advanced Rehabilitation Technology for Neurological Disorders

Overseen By Leslie R VanHiel, DScPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rehabilitation Hospital of Overland Park

Disqualifiers: Other studies, Contraindications, Conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Average of 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether advanced robotic devices and technology in inpatient rehab for people with neurological conditions can improve recovery outcomes and be cost-effective. Participants will receive either traditional rehab or rehab with new tech tools, such as EKSO Bionics (a robotic exoskeleton) and Thera-Trainer, to determine if the technology enhances recovery speed or quality. The trial seeks participants currently in rehab with a neurological diagnosis who can sit or stand upright for rehab activities. The goal is to assess whether the technology can deliver similar or better results at a lower cost. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform future rehabilitation practices.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that these robotic devices and advanced technologies are safe for neurological rehabilitation?

Research shows that EKSO Bionics exoskeletons, such as the EKSO-GT, are generally safe for people with spinal cord injuries. These devices help patients walk safely in everyday settings. Studies have found that patients tolerate them well during rehab sessions, with regular safety checks conducted.

For Fourier Intelligence's devices, detailed safety information is not readily available. However, their robotic rehab systems have aided recovery from mobility issues and brain conditions.

Thera-Trainer's technology, particularly in robot-assisted walking rehab, has shown promising results in improving walking abilities. Although specific safety data is not highlighted, the technology benefits outcomes in neurological conditions.

Tyromotion's devices, like the Amadeo, have been used in studies that show improvements in limb function after a stroke. Evaluations of their safety and acceptance in high-intensity training have been positive, indicating they are well-received by patients.

In summary, while detailed safety data is limited for some technologies, research suggests these advanced rehab devices are generally safe and effective for aiding recovery in neurological patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the advanced rehabilitation technology being explored for neurological disorders because it integrates cutting-edge robotics and AI to enhance recovery. Unlike traditional physical therapy, which relies heavily on manual techniques by therapists, these technologies—like EKSO Bionics and Fourier Intelligence—offer precise, customizable support and feedback to patients. This can lead to more efficient and targeted rehabilitation, potentially speeding up recovery times and improving outcomes for patients with conditions like stroke or spinal cord injuries. Additionally, these technologies can provide consistent and repeatable therapy sessions, which are crucial for neurological rehabilitation.

What evidence suggests that this trial's treatments could be effective for neurological disorders?

This trial will compare inpatient rehabilitation with advanced rehabilitation technology (ART) to rehabilitation without ART. Research has shown that using EKSO Bionics exoskeletons, one of the technologies in this trial, can help stroke patients walk better and improve their overall physical abilities. In a study of 310 stroke patients, participants demonstrated clear improvements in these areas. Fourier Intelligence's robotic solutions, also part of this trial, are designed to aid recovery from movement problems and brain-related conditions. Thera-Trainer’s therapy devices, another technology being tested, have significantly improved walking in patients with serious neurological issues. Tyromotion's robotic devices, included in this trial, have enhanced arm function and reduced overall disability. These technologies hold promise for improving rehabilitation outcomes for people with neurological disorders. ^{1 2 4 6 7}

Who Is on the Research Team?

Brett Schoen, MD

Principal Investigator

Rehabilitation Hospital of Overland Park

Are You a Good Fit for This Trial?

This trial is for adults over 18 with neurological disorders who are in inpatient rehab and can stay at least 7 days. They must be able to communicate, follow commands, fit into a device, and tolerate certain positions. Excluded are those with conditions limiting study benefits or involved in another study.

Inclusion Criteria

Predicted length of stay to be at least 7 days

I can communicate pain, stop a session if needed, and follow simple instructions.

I am currently in inpatient rehab at Overland Park for a neurological condition.

Exclusion Criteria

Currently involved in another intervention study

Any absolute contraindication listed for each device used

Any pre-existing physical or medical condition that the Physiatrist determines would significantly limit a patient's ability to benefit from or continue in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inpatient rehabilitation with or without advanced rehabilitation technology

Average of 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EKSO Bionics
• Fourier Intelligence
• Thera-Trainer
• Tyromotion

Trial Overview The study tests if using robotic devices like Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics during rehab gives similar or better results than standard therapy alone. It's randomized: some get technology-assisted therapy; others don't.

How Is the Trial Designed?

Group I: Inpatient Rehabilitation with ART Experimental Treatment 1 Intervention

Inpatient rehabilitation with advanced rehabilitation technology

Group II: Inpatient Rehabilitation without ART Active Control 1 Intervention

Inpatient rehabilitation without advanced rehabilitation technology

Who Is Running the Clinical Trial?

Rehabilitation Hospital of Overland Park

Lead Sponsor

Trials

1

Recruited

200+

Discovery Statistics

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

Integrating the Ekso Gait Training device into inpatient rehabilitation for patients with stroke or spinal cord injury is feasible, although it faced initial challenges that required administrative support and clinician persistence over several months.

Patients using the Ekso reported improved mobility and tolerated the sessions well, with no complications or adverse incidents, indicating a positive experience with the robotic exoskeleton.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Swank, C., Sikka, S., Driver, S., et al.[2021]

Robotic-assisted gait training (RAGT) using the EksoNR exoskeleton significantly improved gait and functional status in 19 stroke patients over a 4-week rehabilitation program, with notable enhancements in walking ability and mobility.

The study showed statistically significant improvements in various functional categories, including a substantial increase in the number of steps taken and walking time, indicating that RAGT is both effective and well-tolerated for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. Wiśniowska-Szurlej, A., Wołoszyn, N., Brożonowicz, J., et al.[2023]

The Ekso GTTM exoskeleton was successfully implemented in a rehabilitation setting for 26 patients with subacute stroke, showing significant improvements in gait-related measures and overall functional independence after 3 weeks of training.

Patients reported high satisfaction and low perceived exertion during training sessions, indicating that exoskeleton-assisted gait training is a feasible and well-received option for enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the exoskeleton Ekso GTTM for gait rehabilitation in a stroke unit - feasibility, functional benefits and patient experiences. Høyer, E., Opheim, A., Jørgensen, V.[2022]

A study involving 55 physiotherapists and physiatrists revealed that the perceived usefulness of exoskeletons, particularly in saving time and effort, is the primary factor influencing therapists' willingness to adopt this technology for upper limb rehabilitation.

Therapists' acceptance of exoskeletons improves with their prior experience using such technology, highlighting the need for better education and training to increase familiarity and reduce skepticism about robotic rehabilitation tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology Acceptance Model for Exoskeletons for Rehabilitation of the Upper Limbs from Therapists' Perspectives. Luciani, B., Braghin, F., Pedrocchi, ALG., et al.[2023]

Neuromuscular and functional electric stimulation are widely recognized as effective tools for stroke rehabilitation, particularly for improving upper and lower limb function.

While robotic rehabilitation shows some promise for upper limb recovery, its effectiveness for gait training remains uncertain, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative technologies applied to sensorimotor rehabilitation after stroke. Laffont, I., Bakhti, K., Coroian, F., et al.[2018]

The study introduces an active training strategy for lower-limb rehabilitation robots using a spring damping model, which effectively assists patients by following their active interaction forces during rehabilitation, thereby improving joint mobility.

The proposed method has been shown to be stable and feasible for patients with lower limb dysfunction after a stroke, suggesting potential for integration with virtual reality technology to enhance rehabilitation experiences and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spring damping based control for a novel lower limb rehabilitation robot with active flexible training planning. Hu, J., Meng, Q., Zhu, Y., et al.[2023]

The Stroke Rehabilitation Exerciser is designed to enhance rehabilitation for stroke patients by providing personalized motor exercise plans that can be executed at home, improving both efficiency and effectiveness of therapy.

It utilizes a wireless inertial sensor system to track patient movements and offers real-time feedback to both patients and therapists, helping to ensure exercises are performed correctly and intensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home stroke rehabilitation for the upper limbs. Willmann, RD., Lanfermann, G., Saini, P., et al.[2020]

In a study involving 15 post-stroke patients undergoing six weeks of rehabilitation with the Lokomat gait orthosis, significant improvements were observed in various measures of walking ability, including the Fugl-Meyer Motor Scale and the Timed Up and Go test.

The training led to an increase in the firing rate of the vastus medialis muscle without a corresponding increase in muscle strength, suggesting that the Lokomat may enhance motor control through changes in motorneuronal firing rather than just muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training improves motor performances and modifies Motor Unit firing in poststroke patients. Chisari, C., Bertolucci, F., Monaco, V., et al.[2016]

Participants with physical disabilities expressed higher satisfaction with the REX exoskeleton for transferring in and out and its overall appearance, while they preferred the transportability of the Ekso exoskeleton.

Both exoskeletons showed potential for home and community use, but participants suggested that improvements were needed for both devices, with specific changes identified for each.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User satisfaction with lower limb wearable robotic exoskeletons. Poritz, JMP., Taylor, HB., Francisco, G., et al.[2020]

A study involving 54 participants with multiple sclerosis showed high satisfaction levels for both patients and physiotherapists using the EKSO GT® exoskeleton for gait training, indicating its positive impact on rehabilitation.

Patients reported that the effectiveness, safety, and impact on gait were the most valued features of the EKSO GT®, although improvements in comfort and weight of the device were suggested for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Robotic Gait Training in Persons with Multiple Sclerosis: A Satisfaction Study. Fernández-Vázquez, D., Cano-de-la-Cuerda, R., Gor-García-Fogeda, MD., et al.[2021]

The SafeNet methodology enhances the safety of robot-assisted neurorehabilitation systems by allowing the integration of potentially unsafe components, such as sensors and controllers, while maintaining overall system safety through functional safety principles.

A case study demonstrated the application of SafeNet in a robot-assisted upper-limb rehabilitation system, showcasing its ability to monitor and manage safety in real-time, which could improve the clinical application of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems. Vicentini, F., Pedrocchi, N., Malosio, M., et al.[2014]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7199547/

Physiotherapists' Experiences Using the Ekso Bionic ... An exploratory qualitative study of three physiotherapists working at a neurological rehabilitation centre in Eastern Canada was conducted using ...

2. eksobionics.com eksobionics.com/outcomes-of-using-eksonr-in-inpatient-rehab/

Outcomes of Using EksoNR in Inpatient Rehab Average Stroke Patient Statistics. The following data represents the “average” scoring of all of their 310 stroke patients. It is provided so that anyone may ...

3. eksobionics.com eksobionics.com/how-effective-is-exoskeleton-rehabilitation/

How Effective Is Exoskeleton Rehabilitation? In this article, we will explore the current state of research on exoskeleton rehabilitation in physical therapy and consider the potential benefits.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875024001906

Exoskeleton-Assisted Rehabilitation and Neuroplasticity in ... Exoskeleton serves as an emerging and promising tool for rehabilitation, especially in promoting neuroplasticity and alleviating SCI-related complications.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10355131/

Enhanced Rehabilitation Outcomes of Robotic-Assisted ... This study supports previous findings, demonstrating that RAGT using the EksoNR lower extremity exoskeleton improves gait and functional status in stroke ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02600013

Locomotor Training With Exoskeleton EKSO-GT in Patients ... Data on the safety and tolerability of the EKSO-GT training are recorded at the beginning and at the end of each session, however a synthesis of safety ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4809334/

Clinical effectiveness and safety of powered exoskeleton ... Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to ...