Adaptive Hip Exoskeleton for Stroke Rehabilitation

Overseen By Aaron Young, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia Institute of Technology

Disqualifiers: Walker use, Shuffling gait, FAC score 2, Significant secondary deficit, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 year

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a robotic hip exoskeleton to help stroke survivors improve their walking ability. Researchers seek to determine if using the exoskeleton with new software offers more benefits than not using it. Individuals who had a stroke over six months ago, live independently, and can walk without assistance may qualify for the trial. Participants will walk on a special treadmill and other surfaces to evaluate the exoskeleton's performance. As an unphased trial, participants can contribute to innovative research that could enhance rehabilitation options for stroke survivors.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this robotic hip exoskeleton is safe for stroke rehabilitation?

Research has shown that the robotic hip exoskeleton used for stroke recovery is generally safe. Studies have found that this device can significantly improve walking speed, endurance, and balance for stroke survivors. The exoskeleton is well-tolerated. In past studies, participants using the exoskeleton experienced improvements similar to those from traditional rehabilitation methods, without major safety concerns. While caution is always important, current evidence supports the safety of this treatment in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The robotic hip exoskeleton is unique because it offers targeted mechanical assistance to improve walking in stroke survivors, a departure from traditional therapies like physical therapy and orthotic devices that focus on strength and balance. Unlike standard treatments, this exoskeleton provides real-time adaptive support, adjusting to the user's needs, which may enhance mobility and independence more effectively. Researchers are excited about this technology because it has the potential to personalize rehabilitation, offering a high-tech solution that could lead to faster and more sustainable recovery outcomes.

What evidence suggests that this robotic hip exoskeleton is effective for stroke rehabilitation?

Research shows that a robotic hip exoskeleton can significantly improve walking in stroke survivors. Studies have found that training with this device increases walking speed and distance, and enhances balance. One study found that the exoskeleton accurately tracks hip movements, providing appropriate support during walking. This trial will evaluate the effectiveness of the powered hip exoskeleton, with some participants also experiencing the unpowered version and baseline conditions. These benefits suggest that the exoskeleton can be a valuable tool in stroke recovery, aiding individuals in regaining mobility. ^{1 3 6 7 8}

Who Is on the Research Team?

Aaron Young, Ph.D.

Principal Investigator

Georgia Institute of Technology

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-85 who've had a stroke at least 6 months ago, can walk a bit without support, and have basic mental and physical capabilities to participate in the study. Those with severe neurological conditions other than stroke, recent concussions, certain heart diseases, or major sensory impairments cannot join.

Inclusion Criteria

Are able to provide informed consent to participate in the study activities

Are community dwelling, which means the participant does not live in an assisted living facility

I can walk by myself without anyone's help.

Exclusion Criteria

I need a walker to move around on my own.

I walk with a shuffling pattern.

I need someone's help to walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants perform movement tasks without the exoskeleton to establish baseline measurements

1-2 weeks

1 visit (in-person)

Treatment

Participants use the hip exoskeleton in both powered and unpowered states during various movement tasks

1 year

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Hip Exoskeleton

Trial Overview

The trial tests an advanced robotic hip exoskeleton designed to enhance walking post-stroke. Participants will use this device on a treadmill while researchers compare their gait performance with and without the exoskeleton's new algorithms.

How Is the Trial Designed?

Group I: Hip Exoskeleton for Stroke Gait Assistance Experimental Treatment 3 Interventions

This study will be conducted on a sample population of stroke subjects (single arm). Subjects will be tested with either the powered hip exoskeleton and baseline or powered hip exoskeleton, unpowered hip exoskeleton, and baseline.

Who Is Running the Clinical Trial?

Georgia Institute of Technology

Lead Sponsor

Trials

53

Recruited

5,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study of 38 post-stroke patients, those who received robotic-exoskeleton-assisted rehabilitation showed significantly greater improvements in knee flexion torque, walking distance, and quality of life compared to those receiving standard rehabilitation alone.

Robotic training was identified as the strongest predictor of improvement in walking speed and overall health-related quality of life, highlighting its effectiveness in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Robotic-Exoskeleton-Assisted Gait Rehabilitation and Predictive Factors of Significant Improvements in Stroke Patients: A Randomized Controlled Trial. Lee, YH., Ko, LW., Hsu, CY., et al.[2023]

Exoskeleton-assisted gait training using the Healbot G significantly increased cortical activity in stroke patients compared to traditional treadmill training, indicating enhanced brain engagement during rehabilitation.

Patients in the Healbot G group showed significant improvements in walking ability, balance, and lower limb strength, demonstrating the efficacy of exoskeleton training in enhancing recovery post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Training with a Powered Exoskeleton on Cortical Activity Modulation in Hemiparetic Chronic Stroke Patients: A Randomized Controlled Pilot Trial. Yoo, M., Chun, MH., Hong, GR., et al.[2023]

A study involving nine ambulatory stroke survivors tested a novel hip exoskeleton, but no significant differences were found in functional outcomes like speed or gait symmetry compared to baseline conditions.

Some participants reported improved perceived walking ability outdoors with the exoskeleton, suggesting potential benefits for certain individuals, but concerns about the device's weight and assistance highlight the need for further development in hip exoskeleton technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards meaningful community ambulation in individuals post stroke through use of a smart hip exoskeleton: a preliminary investigation. Herrin, K., Upton, E., Young, A.[2023]

In a study involving 44 participants with acute stroke, those using robotic exoskeletons (RE) for gait training walked twice the distance compared to those receiving standard care, indicating enhanced rehabilitation potential.

The RE group also showed a greater improvement in functional independence, as measured by the Functional Independence Measure (FIM), suggesting that increased dosing of gait training through RE may lead to better motor function recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. Nolan, KJ., Karunakaran, KK., Chervin, K., et al.[2020]

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 study involving 46 subacute stroke patients demonstrated that overground exoskeleton-assisted gait training (OEAGT) significantly improved clinical and gait outcomes, with many patients regaining the ability to walk after treatment.

Patients reported a positive acceptance of the OEAGT, indicating its potential as an innovative rehabilitation strategy, although further randomized studies with larger samples are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Goffredo, M., Guanziroli, E., Pournajaf, S., et al.[2020]

Citations

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In the study, a robotic hip exoskeleton (RHE) was utilized to implement an enhanced gait phase estimation (GPE) algorithm integrated with a ...

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