Rehabilitation Robot for Stroke Recovery

Overseen By Mansoo Ko, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Diabetes, Neurological diseases, Cardiac failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve walking patterns for people recovering from a stroke using a special rehabilitation robot called Morning Walk®. The robot helps users regain balance and symmetry while walking. Individuals who experienced a single stroke at least a month ago and can walk 10 meters, even with a walking aid, may be suitable for this study.

As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation technology.

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 prior data suggests that the Morning Walk® rehabilitation robot is safe for stroke recovery?

Research has shown that the Morning Walk® rehabilitation robot is safe for stroke recovery. The FDA has approved it, confirming it meets strict safety standards. Studies have found that this robot helps individuals regain balance and improve walking post-stroke. The process is straightforward and can start quickly, often in just three minutes.

Although no specific side effects have been reported, FDA approval and emphasis on safe use suggest it is well-tolerated. This makes it a reliable option for those seeking to enhance their walking after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a rehabilitation robot for stroke recovery because it offers a new way to enhance motor function. Unlike traditional therapies that rely heavily on human therapists, this robotic system can provide consistent, repetitive movement training tailored to the individual's needs. This technology aims to improve the recovery process by offering precise and controlled exercises that can be challenging to achieve manually. By potentially increasing the intensity and duration of rehabilitation sessions, the robot could lead to faster and more effective recovery for stroke patients.

What evidence suggests that the Morning Walk® rehabilitation robot is effective for stroke recovery?

This trial will evaluate the effectiveness of the Morning Walk® for stroke recovery. Studies have shown that robot-assisted gait training (RAGT), such as the Morning Walk®, can help stroke survivors improve their walking. Research indicates that patients using RAGT experience significant improvements in walking ability, speed, and balance. Specifically, one study found that the Morning Walk® led to better movement in the leg affected by the stroke. Patients reported improvements in movement and balance after using this robotic tool. These findings suggest that the Morning Walk® can effectively help stroke survivors regain their walking abilities. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults who have an uneven walking pattern due to a stroke (hemiparesis) and also includes healthy individuals. Participants should be able to follow the study procedures. People with other medical conditions that could interfere with their participation or those who can't use the Morning Walk® robot are excluded.

Inclusion Criteria

Volunteers fulfilling the inclusion criteria from participating physical therapy facilities and the local community

I had my first stroke over a month ago, can walk 10 meters, and live at home without major complications.

Exclusion Criteria

Blindness

I have been diagnosed with heart failure.

My health is currently unstable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Training Assessment

Assessment of functional and balance capacity using walking tests on the Zeno Walkway system and video recording

1 day

1 visit (in-person)

Training

Participants undergo training with the Morning Walk® rehabilitation robot, with adjustments to training parameters based on individual capacity

4 weeks

Multiple sessions (in-person)

Post-Training Assessment

Immediate post-adaptation effect assessment using the Zeno Walkway system to evaluate gait speed and spatiotemporal gait parameters

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Morning Walk

Trial Overview

The study tests how well the Morning Walk® rehabilitation robot helps improve symmetrical walking in people affected by stroke compared to healthy individuals. The device has been cleared by the FDA, ensuring it's safe and potentially effective for this purpose.

How Is the Trial Designed?

Group I: Morning Walk Training for Stroke Experimental Treatment 1 Intervention

Group II: Morning Walk Training for Healthy Active Control 1 Intervention

Morning Walk is already approved in United States for the following indications:

Approved in United States as Morning Walk for:

• Stroke rehabilitation
• Gait training for neurological deficits

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Published Research Related to This Trial

Robot-assisted gait training, when combined with physiotherapy and body-weight support, significantly improves gait speed, balance, and functional ambulation in stroke patients, based on a review of 33 studies with 1466 participants.

The analysis suggests that previous studies may have underestimated the effectiveness of this intervention due to biases related to participant drop-out rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of robotic gait training after stroke: A meta-analysis. Moucheboeuf, G., Griffier, R., Gasq, D., et al.[2021]

Robotic-assisted gait training (RAGT) significantly improved the ability to walk independently in patients after subacute stroke, as indicated by higher functional ambulatory capacity scores compared to regular physiotherapy alone, based on a study of 67 patients over 6 weeks.

Patients receiving RAGT also showed better neurological status improvements, suggesting that this treatment may enhance recovery outcomes in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. Schwartz, I., Sajin, A., Fisher, I., et al.[2022]

A study involving 18 stroke survivors with severe hemiplegia demonstrated that early in-bed rehabilitation using a wearable ankle robot significantly improved motor function, strength, and range of motion compared to a control group receiving standard passive movement.

The robot-guided training, which included real-time feedback and active movement exercises, led to earlier recovery of ankle movements, highlighting its potential as an effective intervention for enhancing rehabilitation outcomes in acute stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. Zhang, C., Huang, MZ., Kehs, GJ., et al.[2023]

Over 2,000 hours of robot-aided therapy with 76 stroke patients demonstrated a positive effect on reducing impairment and promoting brain reorganization, suggesting that this technology can enhance recovery after a stroke.

The use of back-driveable robots allows for precise control of therapy and objective measurement of patient performance, which could lead to more effective and tailored rehabilitation strategies compared to traditional clinical scales.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing productivity and quality of care: robot-aided neuro-rehabilitation. Krebs, HI., Volpe, BT., Aisen, ML., et al.[2016]

A wearable ankle robotic device was tested on 10 acute stroke survivors over 12 sessions, showing that early in-bed rehabilitation can enhance motor control and promote neuroplasticity.

The device offers both passive stretching and active movement training, using real-time feedback to guide patients, which is crucial for effective motor recovery shortly after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. Ren, Y., Wu, YN., Yang, CY., et al.[2019]

In a study of 24 stroke survivors, those who underwent 6 weeks of training with a portable rehabilitation robot showed significantly greater improvements in spasticity, mobility, balance, and strength compared to those who followed a home exercise program.

Both groups experienced some improvements in mobility and strength, but the robot-assisted training was more effective in enhancing overall motor function and mobility after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. Waldman, G., Yang, CY., Ren, Y., et al.[2016]

The Variable Automated Speed and Sensing Treadmill (VASST) showed promising results in improving walking speed and distance in 10 chronic hemiplegic patients after 4 weeks of training, with 70% of participants experiencing significant gains in gait speed.

No adverse events were reported during the study, indicating that VASST training is safe for stroke survivors, making it a feasible option for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot clinical trial on a Variable Automated Speed and Sensing Treadmill (VASST) for hemiparetic gait rehabilitation in stroke patients. Chua, KS., Chee, J., Wong, CJ., et al.[2020]

Robot-assisted rehabilitation devices, like the Bi-Manu-Track and the electromechanical gait trainer GT I, have shown effectiveness in improving motor recovery for stroke and spinal cord injury patients compared to traditional methods.

The HapticWalker, a new robotic walking simulator, allows for personalized gait training by adjusting foot trajectories for individual patients, enhancing patient-machine interaction and potentially improving rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper and lower extremity robotic devices to promote motor recovery after stroke -recent developments. Schmidt, H., Hesse, S., Werner, C., et al.[2020]

Robot-assisted therapy significantly improved motor function and arm activity in chronic stroke patients compared to a dose-matched active control therapy, as shown by various assessments including the Fugl-Meyer Assessment Scale and ABILHAND questionnaire.

The study involved 20 patients who received either therapy for 90-105 minutes daily over four weeks, demonstrating that robotic therapy can enhance both objective motor skills and patients' self-perception of their arm abilities long after their stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of robot-assisted upper limb rehabilitation on daily function and real-world arm activity in patients with chronic stroke: a randomized controlled trial. Liao, WW., Wu, CY., Hsieh, YW., et al.[2022]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

Assistive walking devices significantly improved functional mobility in 20 nonambulant stroke patients during rehabilitation, with a strong effect size indicating that 2 to 5 patients need to use these devices for one to see a noticeable improvement.

Despite the positive impact on mobility, the devices did not change walking impairments such as speed or step length, but patients reported increased confidence and safety while using them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistive walking devices in nonambulant patients undergoing rehabilitation after stroke: the effects on functional mobility, walking impairments, and patients' opinion. Tyson, SF., Rogerson, L.[2018]

Robot-assisted gait training (RAGT) significantly promotes brain reorganization in the non-injured hemisphere of stroke patients, enhancing recovery compared to conventional physiotherapy.

Starting RAGT early after stroke leads to faster reorganization in both hemispheres of the brain, particularly in motor-related areas, suggesting that timing of intervention is crucial for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training promotes brain reorganization after stroke: A randomized controlled pilot study. Kim, DH., Kang, CS., Kyeong, S.[2020]

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The pooled results demonstrated significant improvements in gait function (SMD = 0.51), gait speed (SMD = 0.47), balance (MD = 4.58), and ...

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After training, all outcome measures significantly improved in both groups. In Motricity Index-Lower of the affected limb, the Morning Walk® group (∆mean ± SD; ...

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sciencedirect.com/science/article/pii/S2666459325000447

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AI-assisted stroke rehabilitation shows promising outcomes in terms of functional and motoric outcomes. Barthel and Motricity Index are used in this study.

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This study provides evidence that RAGT can enhance lower extremity function, balance function, walking ability, and endurance levels compared to CGT.

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The Morning Walk S200 is a robotic automated system designed for muscle rebuilding and joint mobility recovery to aid in the restoration of ...

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Morning Walk | Rehabilitation robot

Morning Walk S200 is an end-effector type gait rehabilitation robot system ... Through a safe and simple process, training can be started within 3 minutes.

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The Morning Walk® is a stationary end-effector type model with a seating-based body weight support system, which uses a footplate to guide the ...

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Rehabilitation Robot for Stroke Recovery

The Morning Walk treatment is unique because it involves a rehabilitation robot specifically designed for stroke recovery, focusing on early and intensive gait ...