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

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: Terminated
• Conditions: Stroke; Gait, Hemiplegic
• Intervention / Treatment: Behavioral: High intensity gait training; Behavioral: Exoskeleton mediated gait training

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Demographic Questionnaire	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)	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)	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)	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	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	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	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)	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)	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)	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	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

Outcome Measure	Measure Description	Time Frame
Patient compliance	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

• Sponsor: Alvernia University
• Collaborators: Good Shepherd Rehabilitation Network
• Investigators: Principal Investigator: Soo Yeon Sun, PhD, Alvernia University; Principal Investigator: Kelley Limbauan, PT, DPT, NCS, Good Shepherd Rehabilitation Network

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: health literacy; balance; gait function; exoskeleton; compliance to therapy; high intensity gait training
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID 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