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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Allentown

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alvernia University,

Soo Yeon Sun, PhD, PRINCIPAL_INVESTIGATOR, Alvernia University

Kelley Limbauan, PT, DPT, NCS, PRINCIPAL_INVESTIGATOR, Good Shepherd Rehabilitation Network

Study Record Dates

2025-12-30