Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training

NCT ID: NCT06478680

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-05-30

Brief Summary

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The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

Detailed Description

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Conditions

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Stroke Gait, Hemiplegic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High intensity gait training

One session of conventional neurorehabilitation intervention per week One session of Forward Walking with EksoGT per week

Group Type ACTIVE_COMPARATOR

High intensity gait training

Intervention Type BEHAVIORAL

2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18

* Forward stepping practice
* Backwards stepping practices
* Sidestepping
* Stairs
* Balance and compliant surface training while walking
* Propulsion
* Lateral balance training
* Stability training
* Stance control training
* Limb advancement

Exoskeleton mediated gait training

Two sessions of High-Intensity Gait Training

Group Type EXPERIMENTAL

Exoskeleton mediated gait training

Intervention Type BEHAVIORAL

1 session of Forward Walking with EksoGT per week

1 session of conventional neurorehabilitation intervention per week

* Transfer training
* Gait training
* Balance (sitting/standing; static/dynamic)
* Strength
* Neuromuscular re-education
* Orthotics
* Positioning
* Caregiver education
* Assistive device
* Wheelchair assessment and mobility
* Endurance training

Interventions

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Exoskeleton mediated gait training

1 session of Forward Walking with EksoGT per week

1 session of conventional neurorehabilitation intervention per week

* Transfer training
* Gait training
* Balance (sitting/standing; static/dynamic)
* Strength
* Neuromuscular re-education
* Orthotics
* Positioning
* Caregiver education
* Assistive device
* Wheelchair assessment and mobility
* Endurance training

Intervention Type BEHAVIORAL

High intensity gait training

2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18

* Forward stepping practice
* Backwards stepping practices
* Sidestepping
* Stairs
* Balance and compliant surface training while walking
* Propulsion
* Lateral balance training
* Stability training
* Stance control training
* Limb advancement

Intervention Type BEHAVIORAL

Other Intervention Names

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EksoGT-mediated gait training

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* English or Spanish-speaking
* A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
* Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic

Exclusion Criteria

* Unable to follow 1-step commands
* \> 220 pounds (100 kg)
* Height \< 5'0" or \> 6'4"
* Unable to take a few steps with assistance
* A score of ≥ 50/56 on Berg Balance Scale (BBS)
* A score of ≥ 26/30 on Functional Gait Assessment (FGA)
* Resting blood pressure \>180/110 mmHg
* Resting heart rate \> 120 bpm
* Severe cardiac disease (New York Heart Association Classification IV)
* Severe spasticity (Modified Ashworth score \> 3)
* Unstable spine or unhealed pelvic/limb fractures
* Active heterotrophic ossification impacting lower extremity range of motion
* Significant lower or upper extremity contractures
* Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
* Pregnancy
* Colostomy
* Poor skin integrity in areas in contact with the EksoGTTM
* Unresolved deep vein thrombosis
* Lower limb prosthesis or amputation
* Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs
* ROM restrictions preventing normal, reciprocal gait
* Inability to stand for \> 3 minutes due to pain or orthostatic hypotension
* Pusher syndrome
* Cortical blindness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Good Shepherd Rehabilitation Network

OTHER

Sponsor Role collaborator

Alvernia University

OTHER

Sponsor Role lead

Responsible Party

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Soo Yeon Sun, PT, PhD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Yeon Sun, PhD

Role: PRINCIPAL_INVESTIGATOR

Alvernia University

Kelley Limbauan, PT, DPT, NCS

Role: PRINCIPAL_INVESTIGATOR

Good Shepherd Rehabilitation Network

Locations

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Good Shepherd Rehabilitation

Allentown, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2176775-1

Identifier Type: -

Identifier Source: org_study_id

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