← Back to Search

Exoskeleton

Powered Exoskeleton for Knee Osteoarthritis

Q: What is the overall size of the sample group participating in this research project?

<p>Absolutely. According to the data hosted by clinicaltrials.gov, this medical experiment is actively searching for patient participants and was first published on June 1st 2021 before being updated April 21th 2022. A total of 26 people are needed at one site for the trial's completion.</p>

Q: Are there any enrolling opportunities for individuals to participate in this trial?

<p>Yes, evidence on clinicaltrials.gov supports the assertion that this medical trial is looking for new enrollees. It was initiated on June 1st 2021 and last edited April 21st 2022; 26 individuals are needed to complete enrollment at a single site.</p>

N/A

Recruiting

Led By Ann M Spungen, EdD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

self-reported limitations to mobility and walking activities due to knee pain, stiffness, loss of range of motion

medical diagnosis of Grade 3 or 4 knee OA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)

Awards & highlights

Study Summary

This trial is testing whether a robotic exoskeleton can help people with impaired mobility walk better than with standard knee braces.

Who is the study for?

This trial is for veterans with severe knee osteoarthritis (Grade 3 or 4) who experience pain and mobility limitations, have used a knee brace for at least three months, and struggle with activities like standing, walking, or climbing stairs. It's not suitable for those with neurological paralysis, normal walking speed, incompatible body measurements for the device, certain medical conditions (like cardiovascular issues), cognitive impairment as per MacCAT-T score <8/10, pregnancy/planning to become pregnant or joint contractures.Check my eligibility

What is being tested?

The study tests the Keeogo robotic exoskeleton designed to assist knees during movement against standard knee braces. The goal is to see if it improves mobility outcomes in lab tests such as walk test and stair test; reduces pain; and increases user satisfaction among people with impaired mobility due to knee osteoarthritis.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include discomfort from wearing the device, skin irritation where it contacts the body, muscle fatigue from new movement patterns or possible falls due to unfamiliarity with using an exoskeleton.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have difficulty moving or walking because of knee pain and stiffness.

Select...

I have severe knee arthritis.

Select...

I have been using a prescribed knee brace for over three months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 minutes for each condition: 1) using the keeogo, 2) using the prescribed knee brace, and 3) using nothing on the knee (optional) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Changes of 13-Step Stair Test results among different conditions

Changes of 6-Minute Walk Test results among different conditions

Changes of Pick Up Penny from Floor Test results among different conditions

+2 more

Secondary outcome measures

Changes of Numeric Pain Rating Scale results among different conditions

System Usability Scale

Usefulness Satisfaction and Ease of Use Questionnaire

Trial Design

1Treatment groups

Experimental Treatment

Group I: Knee OA groupExperimental Treatment1 Intervention

Individuals who are over 18 years and have medical diagnosis of Grade 3 or 4 knee OA

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Keeogo

2017

N/A

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,258 Total Patients Enrolled

21 Trials studying Osteoarthritis

3,515 Patients Enrolled for Osteoarthritis

VA Pittsburgh Healthcare SystemFED

32 Previous Clinical Trials

11,383 Total Patients Enrolled

Ann M Spungen, EdDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

6 Previous Clinical Trials

851 Total Patients Enrolled

Media Library

Keeogo (Exoskeleton) Clinical Trial Eligibility Overview. Trial Name: NCT04653896 — N/A

Osteoarthritis Research Study Groups: Knee OA group

Osteoarthritis Clinical Trial 2023: Keeogo Highlights & Side Effects. Trial Name: NCT04653896 — N/A

Keeogo (Exoskeleton) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04653896 — N/A

Osteoarthritis Patient Testimony for trial: Trial Name: NCT04653896 — N/A

Frequently Asked Questions

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

What is the overall size of the sample group participating in this research project?

"Absolutely. According to the data hosted by clinicaltrials.gov, this medical experiment is actively searching for patient participants and was first published on June 1st 2021 before being updated April 21th 2022. A total of 26 people are needed at one site for the trial's completion."

Answered by AI

Are there any enrolling opportunities for individuals to participate in this trial?

"Yes, evidence on clinicaltrials.gov supports the assertion that this medical trial is looking for new enrollees. It was initiated on June 1st 2021 and last edited April 21st 2022; 26 individuals are needed to complete enrollment at a single site."

Answered by AI