100 Participants Needed

Hip Exoskeleton Assistance for Stroke Recovery

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Overseen ByAbbas Alili
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: North Carolina State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12356

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.
See 9 more

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
See 14 more

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?
2Treatment groups
Experimental Treatment
Group I: Group B - Participants with paretic strokeExperimental Treatment3 Interventions
Group II: Group A - Participants without neurological disordersExperimental Treatment3 Interventions

Find a Clinic Near You

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

Citations

Safety & efficacy of a robotic hip exoskeleton on outpatient ...Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke.
Safety & efficacy of a robotic hip exoskeleton on outpatient ...Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke.
Bilateral hip exoskeleton assistance enables faster ...This study demonstrates that powered and bilateral hip exoskeletons may have a positive impact on the mobility of individuals in the chronic ...
A novel real-time assistive hip-wearable exoskeleton robot ...This study aimed to explore the effect of this robot on lower extremity rehabilitation in subacute stroke patients, focusing on gait function, ...
Exoskeleton Assistance for Post-Stroke Gait ImprovementThe Ankle and Hip Exoskeleton treatment is unique because it uses wearable technology to provide powered assistance to the hip and ankle, improving walking ...
NCT05536739 | Adaptive Hip Exoskeleton for Stroke Gait ...The investigators expect improved outcomes in the powered hip exoskeleton compared to the unpowered hip exoskeleton and baseline conditions. Official Title.
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