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

July 8, 2025 updated by: Soo Yeon Sun, PT, PhD, Alvernia University

Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Good Shepherd Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High intensity gait training
One session of conventional neurorehabilitation intervention per week One session of Forward Walking with EksoGT per week
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
Experimental: Exoskeleton mediated gait training
Two sessions of High-Intensity Gait Training
Behavioral: 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
Other Names:
  • EksoGT-mediated gait training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographic Questionnaire
Time Frame: Pre-intervention
Questions include age, sex, date of birth, race/ethnicity, total income during T the past 12 months, main occupation and when was the last work, language at home, marital status, education level, and if they take any antidepressants.
Pre-intervention
Newest Vital Sign (NVS)
Time Frame: Pre-intervention
The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy (HL) based on interpreting an ice cream nutrition label.
Pre-intervention
Patient Health Questionnaire (PHQ-9)
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The PHQ-9 is a self-administered depression screening tool with nine items. It has been reported that the PHQ-9 is the best-performing tool for screening for post-stroke depression.
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
3-Meter Backwards Walk Test (3MBWT)
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The 3MBWT measures the time (in seconds) it takes for a participant to walk 3 meters backward, hence assessing a backward gait speed. Backward gait speed is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk, and balance. Use of assistive devices will be documented.
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
6-Minute Walk Test
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The 6MWT assesses participants' aerobic capacity/endurance by recording the distance (in meters) that the participants walk in 6 minutes. Assistive devices may be used and will be documented.
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
10-meter Walk Test
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The 10mWT assesses walking speed in meters/second (m/s) over a short distance (10m). Two trials are administered at the patient's comfortable walking speed, followed by 2 trials at their fast walking speed, per Physical Therapist's instruction. The 2 trials for each speed are then averaged and the 2 gait speeds (preferred and fast) are documented in m/s. Assistive devices may be used, and will be documented.
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Muscle coactivation index
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Muscle coactivation index will be calculated based on the EMG signals from 8 leg muscles (bilateral tibialis anterior, medial gastrocnemius, rectus femoris, medial hamstring). Surface electromyographic recordings will be conducted during forward and backward walking tests.
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Pre-intervention
The Multidimensional Scale of Perceived Social Support is a 12-item self-administered scale that measures social support. The total score for the MSPSS ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.
Pre-intervention
Berg Balance Scale (BBS)
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The Berg Balance Scale is a 14-item clinician-rated measure that assesses static and balance in sitting and standing. It has a maximum score of 56 points. Each item is scored on a 5-point scale from 0 to 4, with 0 indicating the subject is unable to perform the task and 4 being the highest score.
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Functional Gait Assessment (FGA)
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The Functional Gait Assessment (FGA) is scored on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment and 3 indicating normal ambulation. The total score is calculated by summing all the items and ranges from 0-30, with lower scores indicating greater impairment.
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Borg rating scale of Perceived Exertion
Time Frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 minute walk test. It measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing oneself to the max).
Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient compliance
Time Frame: After 20 interventions (~10 weeks)
Patient attendance to physical therapy is tracked and will be measured as >80% attendance to physical therapy.
After 20 interventions (~10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alvernia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Good Shepherd Rehabilitation Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Soo Yeon Sun, PhD, Alvernia University
  • Principal Investigator: Kelley Limbauan, PT, DPT, NCS, Good Shepherd Rehabilitation Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2176775-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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