Robotic-Assisted Rehabilitation for Stroke

Overseen By Panagiotis Artemiadis, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Neurological conditions, Heart failure, Severe respiratory, others

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

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to improve walking ability in stroke survivors using technology such as belt accelerations, a treadmill, and an exoskeleton (robotic-assisted rehabilitation). The researchers aim to find better methods for enhancing walking speed, which can improve the quality of life for stroke survivors. The trial is open to two groups: healthy individuals and those who had a single stroke over six months ago, provided they can walk for 15 minutes without assistance. Participants should not have serious heart or musculoskeletal issues affecting walking. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative rehabilitation methods.

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 study team to get a clear answer.

What prior data suggests that these rehabilitation methods are safe for stroke patients?

Research shows that using robotic devices like exoskeletons in stroke recovery is generally safe. While some side effects may occur, most people tolerate them well. Studies have found that robotic exoskeletons can improve leg strength, walking speed, and overall quality of life for stroke survivors.

For treadmill-based treatments, research results are mixed. Treadmill training can increase walking distance, but it might not significantly improve walking speed or balance. Treadmills with body weight support, which use a harness, are commonly used in rehabilitation and are considered safe.

Some studies have examined using belt speed changes to aid walking training. This method involves adjusting treadmill speed to assist walking practice. The safety of this approach seems manageable, as the tested speeds are designed to be safe for patients.

In summary, all these treatments have undergone safety testing and are generally well-tolerated, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these robotic-assisted rehabilitation treatments for stroke because they offer innovative ways to enhance recovery. Traditional stroke rehabilitation often involves physical therapy and repetitive exercises, but these new methods use technology to potentially speed up and improve results. Belt accelerations and exoskeletons can provide precise, automated assistance, helping patients regain mobility more effectively. Additionally, the variable stiffness treadmill allows for customizable resistance levels, adapting to each patient's progress and needs. This technology-driven approach could lead to more personalized and efficient rehabilitation, making it a promising development in stroke recovery.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

This trial will explore various robotic-assisted rehabilitation methods for stroke recovery. Studies have shown that belt accelerations can help stroke patients improve balance and walking ability. Approximately 83% of stroke patients experience balance issues, but rehabilitation can address this. Research suggests that combining belt accelerations with an exoskeleton offers additional benefits, as exoskeletons can strengthen muscles, increase walking speed, and enhance quality of life. For the variable stiffness treadmill, past studies have shown mixed results, but intensive treadmill training can increase walking distance. Overall, these methods have the potential to aid recovery and improve walking in stroke survivors. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who are in good health or have had a single stroke over 6 months ago. Healthy participants must pass a fitness questionnaire, while stroke survivors need to walk unassisted for 15 minutes and have their condition confirmed by MRI or CT scan. All must speak English, weigh under 250 lbs, and have stable heart rates and blood pressure.

Inclusion Criteria

I am 18-80, had a stroke over 6 months ago, can walk and follow instructions, and meet the health criteria.

I am 18-80 years old, in good health, speak English, fit based on the PAR-Q, have a resting heart rate of 60-100 bpm, blood pressure of 90/60 to 140/90, and weigh under 250 lbs.

Exclusion Criteria

I have severe breathing issues like COPD.

I was unable to walk on my own before having a stroke.

I do not have recent severe heart issues or uncontrolled heart rhythm problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a series of studies analyzing human gait and adaptations using robotics and neuromuscular modeling

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belt Accelerations
• Belt accelerations combined with an exoskeleton
• Variable Stiffness treadmill

Trial Overview

The study tests different rehabilitation methods using robotics and neuromuscular modeling to improve walking function after stroke. It includes the use of a variable stiffness treadmill, belt accelerations alone, or combined with an exoskeleton to see which method best enhances gait.

How Is the Trial Designed?

Group I: All subjects Experimental Treatment 3 Interventions

All subjects (healthy and stroke survivors) participating in the study

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Published Research Related to This Trial

The study found that the Balance Assessment Robot for Treadmill walking (BART) effectively emulates inclined treadmill walking, showing similar ground reaction forces (GRF) during hill walking, which could be beneficial for stroke rehabilitation.

Turning emulation on BART also demonstrated similarities in GRF data to actual overground turning, suggesting that this robotic approach may help in practicing important gait skills for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emulation of hill walking and turning on Balance Assessment Robot: A preliminary study. Zadravec, M., Olensek, A., Matjacic, Z.[2020]

Robot-assisted treadmill training leads to a more symmetrical pattern of muscle activity in stroke patients compared to overground walking, suggesting it may help in gait rehabilitation.

While muscle activity is lower during robotic walking than overground walking, the activity patterns in stroke patients during robotic walking are similar to those of able-bodied individuals, indicating potential benefits in restoring gait function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted walking vs overground walking in stroke patients: an evaluation of muscle activity. Coenen, P., van Werven, G., van Nunen, MP., et al.[2016]

A new robot-aided treadmill training method allows patients to intuitively control their walking speed by measuring their trunk position and interaction forces, making rehabilitation more interactive and user-friendly.

This approach was tested on ten healthy subjects and successfully mimicked normal walking speed profiles, suggesting it could enhance rehabilitation for patients with locomotor dysfunctions and be adapted for various walking conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel method for automatic treadmill speed adaptation. von Zitzewitz, J., Bernhardt, M., Riener, R.[2019]

In a study involving 11 patients with incomplete spinal cord injury, patient-cooperative robot-aided gait training led to greater kinematic variability and increased muscle activity compared to non-cooperative training, suggesting enhanced engagement during rehabilitation.

The patient-cooperative approach, which allowed for free timing of movements and individually adjusted support, resulted in a more active participation from patients, indicating it may be a more effective method for gait rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-cooperative control increases active participation of individuals with SCI during robot-aided gait training. Duschau-Wicke, A., Caprez, A., Riener, R.[2021]

The Variable Stiffness Treadmill (VST) demonstrated the ability to significantly increase step length in healthy subjects for over 575 gait cycles after just a single 10-minute session, indicating its potential effectiveness in gait rehabilitation.

This robotic treadmill's unique mechanism of creating unilateral stiffness perturbations may offer a novel approach to post-stroke rehabilitation, potentially leading to lasting improvements in gait compared to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using robot-assisted stiffness perturbations to evoke aftereffects useful to post-stroke gait rehabilitation. Chambers, V., Artemiadis, P.[2023]

A new robotic orthosis powered by pneumatic muscle actuators was developed for treadmill training, specifically designed for individuals with neurological impairments, allowing for natural hip and knee movements.

Testing on a healthy subject demonstrated that the orthosis effectively supports physiological gait patterns and provides a realistic stepping experience, indicating its potential for rehabilitation use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intrinsically compliant robotic orthosis for treadmill training. Hussain, S., Xie, SQ., Jamwal, PK., et al.[2016]

A pilot study involving six stroke survivors with severe chronic hemiparesis demonstrated that an electromyography (EMG)-controlled exoskeletal robotic brace significantly improved upper-extremity function, as measured by the Fugl-Meyer scale, with a notable increase from 15.5 to 19 (P = 0.04).

The study also showed a significant reduction in muscle hypertonicity, with the modified Ashworth scale scores improving from 4.67 to 2.33 (P = 0.009), indicating that the device not only helped with movement but also reduced stiffness in the muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromyography-controlled exoskeletal upper-limb-powered orthosis for exercise training after stroke. Stein, J., Narendran, K., McBean, J., et al.[2016]

In a study involving 18 subjects with chronic gait deficits after stroke, slow robot-assisted locomotor training on a bodyweight-supported treadmill led to significant improvements in multiple measures of mobility and balance, including the functional ambulation category and the Berg Balance Scale.

Fast robot-assisted training also showed benefits, but the slow training was more effective in enhancing discrete movements, suggesting that targeting slower speeds may be more beneficial in the early stages of rehabilitation after a severe stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow Versus Fast Robot-Assisted Locomotor Training After Severe Stroke: A Randomized Controlled Trial. Rodrigues, TA., Goroso, DG., Westgate, PM., et al.[2017]

The individualized treadmill controller for user-driven walking (UDW) allows for gait biomechanics similar to traditional treadmill-driven walking (TDW), making it a safe and effective option for gait training in controlled environments.

UDW enhances cognitive engagement during virtual reality applications, potentially improving motor learning outcomes compared to standard treadmill training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel walking speed estimation scheme and its application to treadmill control for gait rehabilitation. Yoon, J., Park, HS., Damiano, DL.[2021]

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]

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