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

NCT06478680 | Terminated

• 1 other identifier: 2176775-1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Gait, Hemiplegic

Keywords

health literacy; balance; compliance to therapy; gait function; high intensity gait training; exoskeleton

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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)

• 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 Outcomes (1)

• Patient compliance

  After 20 interventions (~10 weeks)

Study Arms (2)

High intensity gait training

ACTIVE COMPARATOR

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

Behavioral: High intensity gait training

Exoskeleton mediated gait training

EXPERIMENTAL

Two sessions of High-Intensity Gait Training

Behavioral: Exoskeleton mediated gait training

Interventions

Exoskeleton mediated gait training 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

Also known as: EksoGT-mediated gait training

Exoskeleton mediated gait training

High intensity gait training 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

High intensity gait training

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alvernia University: lead
• Good Shepherd Rehabilitation Network: collaborator

Study Sites (1)

Good Shepherd Rehabilitation

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Soo Yeon Sun, PhD

  Alvernia University

  PRINCIPAL INVESTIGATOR

• Kelley Limbauan, PT, DPT, NCS

  Good Shepherd Rehabilitation Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: October 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)