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

Trial Summary

What is the purpose of this trial?

This work will focus on new algorithms for robotic exoskeletons and testing these in human subject tests. Individuals who have previously had a stroke will walk while wearing a robotic exoskeleton on a specialized treadmill as well as during other movement tasks (e.g. over ground, stairs, ramps). The study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

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 data supports the effectiveness of the treatment Robotic Hip Exoskeleton for stroke rehabilitation?

Research shows that powered robotic exoskeletons can be safely used for gait training in stroke patients, with sub-acute stroke patients potentially experiencing more benefits compared to traditional therapy. Although some studies did not find significant differences in outcomes, individual responses varied, suggesting potential benefits for some patients. ^{1 2 3 4 5}

Is the adaptive hip exoskeleton safe for stroke rehabilitation?

Clinical trials show that powered robotic exoskeletons, including hip exoskeletons, can be used safely for gait training in stroke rehabilitation. Participants in studies did not report significant safety issues, although some noted the weight and assistance of the exoskeleton as areas needing improvement. ^{1 2 5 6 7}

How does the Robotic Hip Exoskeleton treatment differ from other treatments for stroke rehabilitation?

The Robotic Hip Exoskeleton is unique because it provides targeted assistance at the hip during walking, which may help improve mobility for stroke survivors. Unlike traditional therapies, this wearable device allows for active participation and repetitive walking practice, potentially enhancing motor relearning and gait recovery. ^{1 3 5 7 8}

Research Team

Aaron Young, Ph.D.

Principal Investigator

Georgia Institute of Technology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

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

Towards meaningful community ambulation in individuals post stroke through use of a smart hip exoskeleton: a preliminary investigation. [2023]

2. Switzerland 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. [2023]

3. United States 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. [2023]

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

Stride management assist exoskeleton vs functional gait training in stroke: A randomized trial. [2019]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Robotic Exoskeleton Gait Training During Acute Stroke Inpatient Rehabilitation. [2020]

7. Italy pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. [2020]

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

Immediate Effect of Ankle Exoskeleton on Spatiotemporal Parameters and Center of Pressure Trajectory After Stroke. [2023]