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Hip Exoskeleton Assistance for Stroke Recovery

N/A

Recruiting

Research Sponsored by North Carolina State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have weakness on one side of their body due to a stroke within the past 6 months

Can walk without any assistance for at least 6 minutes and 1000 feet (a little less than a quarter-mile)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 55 months.

Awards & highlights

Study Summary

This trial is investigating a new way to automatically adjust robotic assistance for people using lower limb exoskeletons, in order to improve outcomes and safety. The new method uses reinforcement learning to optimize assistance based on measures other than just metabolic cost.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects aren't specified, but participants may experience discomfort or skin irritation from wearing the exoskeleton, as well as muscle fatigue or strain from adjusting to its use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I can walk at least 1 mile per hour.

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I am between 18 and 64 years old.

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I can move my hip joint in all directions without limitation.

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I can walk on my own without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 55 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 55 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 55 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Human lower limb joints angular position

Human lower limb joints angular velocity

Secondary outcome measures

Human lower limb joints power

Human lower limb joints torque

Human lower limb muscles activity

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B - Participants with paretic strokeExperimental Treatment3 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 disordersExperimental Treatment3 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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

North Carolina State UniversityLead Sponsor

33 Previous Clinical Trials

15,460 Total Patients Enrolled

5 Trials studying Stroke

204 Patients Enrolled for Stroke

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,190,516 Total Patients Enrolled

17 Trials studying Stroke

12,449 Patients Enrolled for Stroke

Media Library

Group A - Participants without neurological disorders Clinical Trial Eligibility Overview. Trial Name: NCT05447884 — N/A

Stroke Research Study Groups: Group A - Participants without neurological disorders, Group B - Participants with paretic stroke

Stroke Clinical Trial 2023: Group A - Participants without neurological disorders Highlights & Side Effects. Trial Name: NCT05447884 — N/A

Group A - Participants without neurological disorders 2023 Treatment Timeline for Medical Study. Trial Name: NCT05447884 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main aims of this investigation?

"The primary aim of this clinical trial, assessed over a 55-month period, is to determine the angular position of human lower limb joints. Secondary objectives include measuring torque and power generated by both biological processes as well as hip exoskeletons, in addition to recording muscle activity using seven-channel surface electromyography sensors on each leg."

Answered by AI

Are there any vacancies for trial participants at this moment?

"As suggested by clinicaltrials.gov, this research project is actively seeking participants. The trial was first published on June 1st 2022 and has since been updated once, most recently on July 1st 2022."

Answered by AI

Does this research seek out seniors to join the experiment?

"To be eligible for this medical experiment, one must reside between the ages of 18 and 64. For those who are younger or older than these parameters, 38 studies exist for under-18s while 1005 trials accommodate those over 65."

Answered by AI

Could you provide an estimate of the number of people partaking in this medical experiment?

"Affirmative, records on clinicaltrials.gov show that this study is actively seeking participants. It was initially announced on June 1st 2022 and last revised on July 1st 2022. A total of 100 people have to be enrolled from one site for the trial to proceed."

Answered by AI

Am I an eligible participant for this trial?

"Patients that wish to take part in this clinical trial must have been affected by stroke and be within the age range of 18-64. There are a total of 100 spots available for participants."

Answered by AI

Recent research and studies

IEEE Transactions on CyberneticsJournal

Online Reinforcement Learning Control for the Personalization of a Robotic Knee Prosthesis

Wen, Yue, Jennie Si, Andrea Brandt, Xiang Gao, and He Helen Huang. 2020. “Online Reinforcement Learning Control for the Personalization of a Robotic Knee Prosthesis”. IEEE Transactions on Cybernetics. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tcyb.2019.2890974.

clinicaltrials.govStudy

Improving Balance and Energetics of Walking Using a Hip Exoskeleton

He Huang 2022. "Improving Balance and Energetics of Walking Using a Hip Exoskeleton". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05447884.