Hip Exoskeleton Assistance for Stroke Recovery

Overseen By Abbas Alili

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: North Carolina State University

Disqualifiers: Stroke, Pacemaker, Pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a hip exoskeleton designed to improve walking, including for those recovering from a stroke. Researchers aim to determine if new smart technology can offer personalized support, making walking easier and safer. The trial includes two groups: one with individuals who have had a stroke and struggle with hip movement, and another with individuals who have normal hip movement. Candidates should have experienced a stroke within the last six months, be able to walk at least six minutes without help, or have a full range of hip motion and walk without assistance. As an unphased trial, participants contribute to innovative research that may enhance mobility solutions for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use an electronically controlled medical device or have uncontrolled diabetes, you may not be eligible to participate.

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

Research shows that hip exoskeletons can safely assist people, including stroke survivors, in improving their walking. Studies have found that these robotic devices enhance walking speed, endurance, and balance for individuals with long-term stroke effects. Most users find the exoskeleton comfortable.

In earlier studies, patients using the exoskeleton did not report major safety issues. The device supports the hips, making movement smoother and more efficient. This proves particularly beneficial for stroke recovery, aiding in walking and balance.

Since this trial does not involve a drug or new chemical treatment, it focuses on the mechanical assistance provided by the exoskeleton. Research so far suggests that the exoskeleton is a promising tool for safe and effective rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the hip exoskeleton for stroke recovery because it offers a fresh approach to improving mobility. Unlike traditional rehabilitation methods that rely on physical therapy and assistive devices, this exoskeleton provides direct mechanical assistance to the hip joint, enhancing movement and strength. By targeting the specific muscles involved in hip motion, it may help stroke survivors walk more effectively and regain independence faster. Plus, its ability to adjust to different terrains and speeds could make it a versatile tool for real-world use.

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

This trial will evaluate the use of a robotic hip exoskeleton for stroke recovery. Studies have shown that a robotic hip exoskeleton can help stroke survivors walk better. These devices significantly increase walking speed, endurance, and balance in those with long-term stroke effects. The exoskeletons provide powered assistance to the hips, making movement easier. Initial findings suggest that this assistance allows for quicker and more stable walking. The technology aims to offer personalized support, adjusting to each person's needs to improve walking ability. Participants in this trial will be divided into two groups: Group A, consisting of individuals without neurological disorders, and Group B, consisting of individuals with paretic stroke. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 living in the US who can walk unassisted and have full hip movement. They must understand the study and agree to participate. It's not clear who can't join because exclusion criteria are missing.

Inclusion Criteria

I have had a stroke in the last 6 months causing weakness on one side.

I can walk unaided for 6 minutes or more, covering at least 1000 feet.

My vision and hearing are normal or corrected to be normal.

Exclusion Criteria

I have difficulty understanding or following instructions due to cognitive or language issues.

I do not have unmanaged heart, blood, metabolic, or cognitive conditions.

You have any skin-related allergies or irritation to adhesives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sessions with the hip exoskeleton to optimize assistance and improve walking functions

8 weeks

Up to 5 sessions, each lasting no longer than 4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hip Exoskeleton

Trial Overview

The study tests a wearable bilateral hip exoskeleton with three modes: zero impedance, personalized optimal assistance, and free walking without the device. The goal is to improve balance and reduce effort during walking by using new control methods.

How Is the Trial Designed?

Group I: Group B - Participants with paretic stroke Experimental Treatment 3 Interventions

Individuals with paretic stroke will be recruited (Group S). Usually, participants from this group have limited hip joint motion of range, weakened hip joint flexion or extension, or both flexion and extension functionalities, but they can also walk independently.

Group II: Group A - Participants without neurological disorders Experimental Treatment 3 Interventions

Individuals without any neurological disorders will be recruited (Group A). Usually, participants from this group are able to walk normally on different terrains and at multiple typical walking speeds.

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials

38

Recruited

50,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

Individuals with moderate mobility impairments (Berg Balance Scale scores of 46-51 and Timed Up and Go times of 8-12 seconds) are most likely to benefit from using the Keeogo™ dermoskeleton, as identified in a study of 13 participants with neurological impairments.

Wearing the Keeogo™ dermoskeleton significantly improved performance in various mobility tests, including the 30-second chair stand and stair climb tests, enhancing motor control, postural stability, and overall movement kinetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Keeogo™ Dermoskeleton. Mcleod, JC., Ward, SJ., Hicks, AL.[2020]

A survey conducted among exoskeleton users highlighted the need for a rigorous risk assessment process to ensure the safety and effectiveness of exoskeleton technology, which is rapidly growing in various applications.

Key safety concerns identified include misalignments and unintended device motion, which could significantly impact user safety and should be addressed in future risk assessments and mitigation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relevance of hazards in exoskeleton applications: a survey-based enquiry. Massardi, S., Pinto-Fernandez, D., Babič, J., et al.[2023]

The Hybrid Assistive Limb (HAL) robot suit significantly improved the forward-tilt angle during the sit-to-stand (STS) movement in stroke patients, increasing from an average of 35° without HAL to 43° with HAL assistance.

While the time taken to perform the STS movement increased with HAL use (from 3.42 seconds to 5.11 seconds), the integrated EMG readings indicated that HAL effectively engaged the vastus medialis muscle, suggesting it may enhance muscle activity during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a hybrid assistive limb(®) on sit-to-stand and standing patterns of stroke patients. Kasai, R., Takeda, S.[2020]

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

The Keeogo™ exoskeleton did not show immediate improvements in physical performance or activity levels in the short term for individuals with knee osteoarthritis, based on a study with 24 participants.

However, over time, users experienced significant cumulative benefits, including improved stair climbing times and reduced pain and stiffness, indicating that the device may enhance long-term mobility and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a lower-extremity robotic exoskeleton for people with knee osteoarthritis. McGibbon, C., Sexton, A., Jayaraman, A., 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]

Lower limb exoskeletons like ReWalk™, Mina, and Indego® have shown effectiveness for walking in controlled laboratory settings for individuals with paraplegia, but their long-term applicability and effectiveness in real-world community settings remain unproven.

The ReWalk™ exoskeleton demonstrated the best walking performance, achieving a maximum speed of 0.51 m/s after 45 sessions, but overall evidence supporting the use of these devices is low, indicating a need for further research on their long-term benefits compared to traditional mobility aids like wheelchairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeletons' design and usefulness evidence according to a systematic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Lajeunesse, V., Vincent, C., Routhier, F., et al.[2018]

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]

Powered hip exoskeletons significantly improved walking speed in stroke patients, with a 17.6% increase using bilateral assistance and an 11.1% increase with unilateral assistance, compared to walking without a device.

Both assistance strategies also enhanced step length for both the affected and unaffected legs, indicating that exoskeletons can effectively improve gait biomechanics and overall mobility post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bilateral Assistance for Hemiparetic Gait Post-Stroke Using a Powered Hip Exoskeleton. Pan, YT., Kang, I., Joh, J., et al.[2023]

In a study involving 14 patients recovering from hip fracture surgery, the HAL lumbar type exoskeleton significantly improved mobility, as shown by a large effect size in the five-times-sit-to-stand test after rehabilitation sessions.

The rehabilitation program using the HAL device was safe, with no adverse events reported, indicating its potential for early postoperative use in enhancing recovery for hip fracture patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Postoperative Rehabilitation Using the Hybrid Assistive Limb (HAL) Lumbar Type in Patients With Hip Fracture: A Pilot Study. Fujikawa, T., Takahashi, S., Shinohara, N., et al.[2022]

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The investigators expect improved outcomes in the powered hip exoskeleton compared to the unpowered hip exoskeleton and baseline conditions. Official Title.