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

Trial Summary

What is the purpose of this trial?

Stroke is the third leading cause of death and the primary cause of long-term disability in the United States, affecting approximately 795,000 people each year. Hemiparesis, or unilateral weakness, is common after stroke and responsible for changes in muscle activation and movement patterns as well as declines in walking speed. It has been shown that increased walking speed directly corresponds to a higher quality of life in older adults and therefore, is often the goal of motor rehabilitation after stroke. However, there is no consensus on the best method for improving walking function after stroke and the results of post-stroke gait studies vary widely across sites and studies. Walking is one of the human's most important functions that serve survival, progress, and interaction. The force between the foot and the walking surface is very important. Although there have been many studies trying to understand this, there is a need for the development of a system that can advance research and provide new functionality. In this work, we will conduct a series of studies that attempt to analyze human gait and adaptations from different perspectives.

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 data supports the effectiveness of the treatment Robotic-Assisted Rehabilitation for Stroke?

Research suggests that robot-assisted treadmill training can be beneficial for stroke rehabilitation by improving muscle activity and gait patterns. The Variable Stiffness Treadmill, a type of robotic treadmill, has shown promising results in increasing step length and improving gait in healthy subjects, which may be useful for post-stroke rehabilitation. ^{1 2 3 4 5}

Is robotic-assisted rehabilitation for stroke generally safe for humans?

Robotic-assisted rehabilitation, including devices like stationary gait robots, is generally safe but can cause some adverse events (unwanted effects). These include skin and tissue injuries, musculoskeletal issues, and changes in blood pressure, often due to pressure and misalignment between the robot and the human body. More detailed reporting and safety measures are needed to further improve safety. ^{1 3 6 7 8}

How does robotic-assisted rehabilitation for stroke differ from other treatments?

Robotic-assisted rehabilitation for stroke is unique because it uses advanced robotic systems to help patients practice walking with intuitive speed adjustments and patient-cooperative control, allowing for more natural and interactive gait training compared to traditional methods. ^{1 4 6 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

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

Patient-cooperative control increases active participation of individuals with SCI during robot-aided gait training. [2021]

2. Sweden pubmed.ncbi.nlm.nih.gov

Robot-assisted walking vs overground walking in stroke patients: an evaluation of muscle activity. [2016]

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

Using robot-assisted stiffness perturbations to evoke aftereffects useful to post-stroke gait rehabilitation. [2023]

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

Slow Versus Fast Robot-Assisted Locomotor Training After Severe Stroke: A Randomized Controlled Trial. [2017]

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

A novel walking speed estimation scheme and its application to treadmill control for gait rehabilitation. [2021]

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

A novel method for automatic treadmill speed adaptation. [2019]

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

Emulation of hill walking and turning on Balance Assessment Robot: A preliminary study. [2020]

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. England pubmed.ncbi.nlm.nih.gov

An intrinsically compliant robotic orthosis for treadmill training. [2016]

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

Electromyography-controlled exoskeletal upper-limb-powered orthosis for exercise training after stroke. [2016]