Robotic Gait Rehabilitation in Parkinson's Disease

NCT05218187 | Terminated FDA Device

• 1 other identifier: 11829
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the implementation of a novel gait rehabilitation stimulus (G-EO System) that could advance current clinical practices. The goal is to establish the safety and feasibility of gait training using the G-EO System as well as investigating the impact on mobility, function, quality of life, and participatory outcomes. Research Design: We propose a single-blinded, randomized trial of electromechanically-assisted gait training using the G-EO System in patients with Parkinson's disease with gait disability. Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System. Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, function, and quality of life

Conditions

Parkinson Disease; Gait Disorder, Sensorimotor

Keywords

End-Effector Gait Training; Robot-Assisted Gait Training; Mobility; Function; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Comfortable Walking Speed (CWS)

  Participants will be asked to walk over a 14-foot pressure mat that will capture their comfortable walking speed. Patients will be instructed to walk at their normal comfortable speed. Walking will begin 5 feet prior to the mat so that each individual walks across the mat at a consistent speed. Participants will pass over the mat 2 times and an average speed will be calculated. It will take 5 minutes to complete this test and will be performed first.

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

• Fast Walking Speed (FWS)

  Participants will be asked to walk over a 14-foot pressure mat that will capture their fast walking speed. Patients will be instructed to walk at their fastest speed while maintaining safe, accurate gait. Walking will begin 5 feet prior to the mat so that each individual walks across the mat at a consistent speed. Participants will pass over the mat 2 times and an average speed will be calculated. It will take 5 minutes to complete this test and will be performed second.

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

• Six Minute Walk Test (6MWT)

  Participants will be asked to walk for 6 minutes along a 30m track that is a flat surface and obstacle free. Subjects may stop and rest as often as needed. Researchers will record the distance traveled during the six minute time period.

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

Secondary Outcomes (5)

• Six Minute Walk Test Walking Speed (6MWT)

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

• Mini BESTest

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

• The Five Times Sit to Stand Test

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

• Activities-Specific Balance Confidence Scale (ABC)

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

• Parkinson's disease Questionnaire-39 (PDQ39)

  Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit

Study Arms (2)

Conventional Physical Therapy (CPT) Group

ACTIVE COMPARATOR

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.

Other: Conventional Physical Therapy Treatment

Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO)

EXPERIMENTAL

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.

Device: G-EO End-Effector Gait Trainer; Other: Conventional Physical Therapy Treatment

Interventions

G-EO End-Effector Gait Trainer DEVICE

The G-EO Gait Trainer uses distal fixation to promote a gait recovery by facilitating a controlled walking environment that includes an over-ground pattern and stair climbing. In addition, the device provides body position control to enable the patient to concentrate on the cyclical motion of walking without the fear of falling. Physical therapists can control different parameters of the gait cycle through computerized adjustments and the training setting can be manipulated to engage patients in active participation.

Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO)

Conventional Physical Therapy Treatment OTHER

Therapists will use traditional methods of neurological rehabilitation for improved gait and balance. These approaches will include stretching, strengthening, therapeutic exercises, balance training, and over-ground walking

Conventional Physical Therapy (CPT) Group; Conventional Physical Therapy (CPT) Group with G-EO Training (CPT-GEO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18years
• Confirmed diagnosis of Parkinson's Disease
• Hoehn and Yahr stage 1 to 3
• Stable course of disease-modifying therapy over the past 3 months
• Mini Mental State Examination \> 24
• Physician approval for exercise
• Stable deep brain stimulation setting for the past year
• Demonstrate a need for functional rehabilitation

You may not qualify if:

• Severe dyskinesia or severe on-off phenomenon
• Unstable medication regiment
• Any co-morbidity that will interfere with walking
• Conventional physical therapy or G-EO training within the past 6 months
• Height \<1m or \>2m
• Body weight \>150 kg
• Contraindications to G-EO gait training (e.g., bone instability)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health Neurorehabilitation and Robotics

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A research coordinator, not involved in subject testing, will be responsible for identification and management of subject group allocation. The research investigation team will conduct all testing and will remain mask to group allocation throughout the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A convenience sample of 30 persons with Parkinson's Disease will be enrolled for this clinical trial. If found eligible for the study and agree to consent to participate, subjects will be randomized to either conventional physical therapy (CPT) group or CPT with G-EO training using a random numbers generator and concealed allocation.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: January 10, 2022
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)