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Robotic Gait Training for Parkinson's Disease

Phase 1 & 2

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Hoehn and Yahr stage 1 to 3

Confirmed diagnosis of Parkinson's Disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up it will take 10 minutes to complete this test. the speed metrics will be recorded while the primary 6mwt data is being captured.

Awards & highlights

Study Summary

This trial will investigate the safety and feasibility of using a new gait rehabilitation stimulus to help patients with Parkinson's disease. The goal is to see if it can improve mobility, function, and quality of life.

Who is the study for?

This trial is for adults over 18 with Parkinson's Disease at stages 1-3, who've been stable on their current medication for the last three months. They must have a Mini Mental State Exam score above 24 and physician approval to exercise. Those with severe movement issues or recent physical therapy are excluded.Check my eligibility

What is being tested?

The study tests a new robotic gait training system (G-EO System) against conventional physical therapy to see if it improves walking, function, and quality of life in Parkinson's patients. Participants will be randomly assigned to one of the treatments without knowing which one they're getting.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort or fatigue from using the G-EO System due to its novel approach to gait rehabilitation.

Eligibility Criteria

Inclusion Criteria

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

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My Parkinson's disease is in the early to mid-stage.

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I have been diagnosed with Parkinson's Disease.

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I am older than 18 years.

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My treatment for my condition has not changed in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ it will take 10 minutes to complete this test. the speed metrics will be recorded while the primary 6mwt data is being captured.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~it will take 10 minutes to complete this test. the speed metrics will be recorded while the primary 6mwt data is being captured.

This trial's timeline: 3 weeks for screening, Varies for treatment, and it will take 10 minutes to complete this test. the speed metrics will be recorded while the primary 6mwt data is being captured. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Comfortable Walking Speed (CWS)

Fast Walking Speed (FWS)

Six Minute Walk Test (6MWT)

Secondary outcome measures

Activities-Specific Balance Confidence Scale (ABC)

Mini BESTest

Parkinson Disease

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO)Experimental Treatment2 Interventions

CPT-GEO sessions will involve a warm-up using a cycle ergometer or treadmill walking, stretching, progressive strength training exercises, and balance training. Gait training will be administered using end-effector gait training protocols (G-EO trainer). Training will be administered 2 times per week for 40-60 minutes for six weeks.

Group II: Conventional Physical Therapy (CPT) GroupActive Control1 Intervention

CPT sessions will involve a warm-up using a cycle ergometer or treadmill walking, stretching, progressive strength training exercises, and balance training. Gait training will be provided using traditional over-ground walking. Additional strategies for home exercises, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. Training will be administered 2 times per week for 40-60 minutes for six weeks.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,246 Total Patients Enrolled

Media Library

G-EO End-Effector Gait Trainer Clinical Trial Eligibility Overview. Trial Name: NCT05218187 — Phase 1 & 2

Parkinson's Disease Research Study Groups: Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO), Conventional Physical Therapy (CPT) Group

Parkinson's Disease Clinical Trial 2023: G-EO End-Effector Gait Trainer Highlights & Side Effects. Trial Name: NCT05218187 — Phase 1 & 2

G-EO End-Effector Gait Trainer 2023 Treatment Timeline for Medical Study. Trial Name: NCT05218187 — Phase 1 & 2

Frequently Asked Questions

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

What is the scope of enrollment for this research trial?

"Affirmative. The clinicaltrials.gov webpage indicates that recruitment for this trial remains ongoing since it was initially posted on 10th January 2022 and the latest update being 1st February 2022. They are hoping to recruit 30 volunteers from a single site."

Answered by AI

What ultimate aim does this research endeavor seek to accomplish?

"This clinical trial will assess the Fast Walking Speed (FWS) of participants over a predetermined time frame. Secondary outcomes to be evaluated include [Parkinson's disease](https://www.withpower.com/clinical-trials/parkinson's-disease) Questionnaire-39 (PDQ39), Mini BESTest, and Activities-Specific Balance Confidence Scale (ABC). PDQ39 is a self-report questionnaire that evaluates quality of life related to Parkinson's disease across eight different dimensions. The mini version of the Balance Evaluation Systems Test(BESTest) consists of fourteen balance tasks while ABC involves scoring sixteen items on a zero to one hundred percent scale regarding confidence in performing activities without losing balance. All tests are estimated to take five minutes"

Answered by AI

Is this clinical trial currently open to new participants?

"Per the information on clinicaltrials.gov, this research trial is currently accepting participants. This experiment was originally announced on October 10th 2022 and has since been modified as recently as February 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Robotic Gait Rehabilitation in Parkinson's Disease

Peter Altenburger 2022. "Robotic Gait Rehabilitation in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05218187.

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