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

37 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Morning Walk, Morning Walk S200, Morning Walk for stroke recovery?

Research shows that robot-aided therapy, including robot-assisted gait training and sensorimotor rehabilitation, can help improve walking ability and brain reorganization after a stroke. These therapies have been shown to reduce impairment and promote motor recovery, suggesting that similar robot-assisted treatments like Morning Walk could be effective for stroke recovery. ^{1 2 3 4 5}

Is the Rehabilitation Robot for Stroke Recovery safe for humans?

Clinical trials show that powered robotic exoskeletons, similar to the Rehabilitation Robot, can be used safely for gait training in stroke patients. These devices have been tested in various studies and are considered safe for human use in rehabilitation. ^{2 3 6 7 8}

How is the Morning Walk treatment different from other stroke recovery treatments?

The Morning Walk treatment is unique because it involves a rehabilitation robot specifically designed for stroke recovery, focusing on early and intensive gait training. Unlike traditional therapies, it uses robotic assistance to help patients relearn walking patterns, potentially improving mobility more effectively than standard physical therapy. ^{2 9 10 11 12}

What is the purpose of this trial?

In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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 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]

References

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

Increasing productivity and quality of care: robot-aided neuro-rehabilitation. [2016]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Robot-assisted gait training promotes brain reorganization after stroke: A randomized controlled pilot study. [2020]

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

Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. [2023]

5. England 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. [2022]

6. United States 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

8. Switzerland 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. [2020]

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

Effects of robotic gait training after stroke: A meta-analysis. [2021]

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

Upper and lower extremity robotic devices to promote motor recovery after stroke -recent developments. [2020]

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

The effectiveness of locomotor therapy using robotic-assisted gait training in subacute stroke patients: a randomized controlled trial. [2022]

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

Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. [2019]