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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

Must not have

Contraindications to G-EO gait training (e.g., bone instability)

Severe dyskinesia or severe on-off phenomenon

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions like bone instability that prevent G-EO gait training.

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I experience severe involuntary movements or sudden changes in my mobility.

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I have a health condition that affects my ability to walk.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comfortable Walking Speed (CWS)

Fast Walking Speed (FWS)

Six Minute Walk Test (6MWT)

Secondary study objectives

Activities-Specific Balance Confidence Scale (ABC)

Mini BESTest

Parkinson Disease

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met