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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

A pre-post, randomized control trial comparing cost-effective and functional outcomes of participants with neurological diagnoses using robotic devices and advanced technology during inpatient rehabilitation to the outcomes of control participants without the use of robotic devices and advanced technology during rehabilitation. We aim to show at least similar inpatient rehabilitation outcomes and improved health economics in participants with neurological diagnoses by using robotic devices and advanced technology to increase the intensity and dose of rehabilitation.

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 data supports the idea that Advanced Rehabilitation Technology for Neurological Disorders is an effective treatment?

The available research shows that Advanced Rehabilitation Technology, like the Ekso Bionics exoskeleton, is effective in improving mobility and user satisfaction for people with neurological disorders. Patients reported improved mobility and high satisfaction after using the Ekso device during rehabilitation. In a study with people with multiple sclerosis, both patients and physiotherapists expressed high satisfaction with the treatment, highlighting its effectiveness and safety. Additionally, therapists found the technology useful for saving time and effort, which increased their willingness to use it. While there are some challenges in integrating these technologies into clinical practice, the overall feedback from users and therapists is positive, indicating that these devices can be a valuable part of rehabilitation. ^{1 2 3 4 5}

What safety data is available for advanced rehabilitation technology for neurological disorders?

The safety data for advanced rehabilitation technology, including devices like Ekso Bionics and Fourier Intelligence exoskeletons, indicates that these devices are generally well-tolerated by patients without complications or adverse incidents. Studies have shown that patients using the Ekso exoskeleton reported improved mobility and satisfaction. However, a systematic review of stationary gait robots found reports of adverse events, such as soft tissue and musculoskeletal injuries, and physiological changes like blood pressure fluctuations. These risks are often due to excessive pressure, shear, and misalignments between the robot and human joints. The need for more structured reporting of adverse events is emphasized to improve safety measures in robotic-assisted rehabilitation. ^{1 5 6 7 8}

Is the treatment in the trial 'Advanced Rehabilitation Technology for Neurological Disorders' promising?

Yes, the treatment is promising. Robotic exoskeletons like the Ekso Gait Training device can help people with neurological disorders learn to walk again. Patients reported improved mobility and felt secure using the device. The technology is becoming more accepted in rehabilitation settings, and it shows potential to improve the effectiveness of therapy. ^{1 9 10 11 12}

Research Team

Brett Schoen, MD

Principal Investigator

Rehabilitation Hospital of Overland Park

Eligibility Criteria

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

I am 18 years old or older.

Predicted length of stay to be at least 7 days

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Technology Acceptance Model for Exoskeletons for Rehabilitation of the Upper Limbs from Therapists' Perspectives. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Robotic Gait Training in Persons with Multiple Sclerosis: A Satisfaction Study. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training improves motor performances and modifies Motor Unit firing in poststroke patients. [2016]

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

User satisfaction with lower limb wearable robotic exoskeletons. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems. [2014]

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

Enhanced Rehabilitation Outcomes of Robotic-Assisted Gait Training with EksoNR Lower Extremity Exoskeleton in 19 Stroke Patients. [2023]

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

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

Innovative technologies applied to sensorimotor rehabilitation after stroke. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Spring damping based control for a novel lower limb rehabilitation robot with active flexible training planning. [2023]

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

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

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

Home stroke rehabilitation for the upper limbs. [2020]