Effects of Backward Gait Training With Exoskeleton on Motor Functions

Investigating Effects of Backward Gait Training With Exoskeleton on Gait Function, Balance and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

The proposed study aims to optimize patient outcomes and treatment intervention using a robotic exoskeleton in adults with cerebrovascular accidents (CVA, stroke) by investigating the following: AIM 1 is to investigate the effect of backward gait training with exoskeleton on motor function.

AIM 2 is to investigate the effect of backward gait training with exoskeleton on depression.

AIM 3 is to investigate the impact of social determinants of health and depression on patient adherence to physical therapy.

Study Overview

• Status: Recruiting
• Conditions: Physical Therapy; Gait, Hemiplegic
• Intervention / Treatment: Device: Gait training with EksoNR; Procedure: Backward gait training with EksoNR

Detailed Description

Based on previous findings on backward gait training as well as the use of a wearable robotic exoskeleton in forward gait training, we hypothesize that backward gait training using exoskeleton leads to greater improvements in functional mobility, neuromuscular control and balance (AIM 1) and depression (AIM 2) in patients with stroke, when compared to standard of care, which includes forward gait training using exoskeleton. Findings from AIM 1 and 2 will provide novel evidence on the effects of backward gait training with exoskeleton in people with stroke and serve as a foundation for optimizing physical therapy protocols to improve motor functions and mental health. AIM 3 investigates the impact of social determinants of health and depression on patient adherence to physical therapy. Patient adherence (also called compliance) refers to the degree to which patients follow treatment recommendations prescribed by their health care provider.34 Even though patient adherence leads to positive treatment outcomes,35,36 it is affected by many factors, including patients' understanding of their disease and associated treatment (i.e., health literacy), social support, and depression.36-38 This experimental study employs a repeated measures design with participants randomly assigned to either a Standard Care with Ekso Group (SCG; control group, n=31) or a Standard Care with Ekso and Backward Walking Group (SCBWG; experimental group, n=31) in AIMs 1 and 2. AIMs 1 and 2 will be achieved using the group assignment as independent variables and motor function and depression as dependent variables. AIM 3 will be achieved using social determinants of health and depression as independent variables and patient adherence to physical therapy as an independent variable.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soo Yeon Sun, PhD; Phone Number: 6107968398; Email: soo.sun@alvernia.edu

Study Locations

• United States
  • New York
    • Schenectady, New York, United States, 12308
      • Not yet recruiting
      • Sunnyview Rehabilitation Hospital
      • Contact: Amy Teale, PhD; Email: amy.teale@sphp.com
      • Principal Investigator: Melanie Melewski, DPT
  • Pennsylvania
    • Reading, Pennsylvania, United States, 19610
      • Recruiting
      • Reading Hospital Rehabilitation at Wyomissing
      • Contact: Karen Keenan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• English or Spanish speaking
• A diagnosis first stroke (intracerebral hemorrhage or acute ischemic stroke)
• Referred to Reading Rehabilitation Hospital Outpatient Physical Therapy Clinic (hereafter referred to as outpatient PT)

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 > 42/56 on Berg Balance Scale (BBS)
• 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
• Psychiatric or cognitive issues that could interfere with operating the exoskeleton
• Pregnancy
• Colostomy
• Poor skin integrity in areas in contact with the EksoNRTM
• 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 > 60 seconds due to pain or orthostatic hypotension

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: Standard Care with Ekso Group; Participants in the SCG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. For each participant, an individualized plan of care consistent with evidence-based practice standards will be provided based on rehabilitation goals. The interventions during each treatment session will include forward gait training with EksoNR, neuromuscular movement-related tasks, mobility tasks, and interventions using products and technology, and education for caregivers, family, and friends.	Device: Gait training with EksoNR; Participants will receive forward gait training with EksoNR
Experimental: Standard Care with Ekso and Backward Walking Group; Participants in the SCBWG (n=31) will attend two 45-minute treatment sessions per week for a minimum of 8 and a maximum of 10 total sessions. Once a week, each participant will receive standard care as described in the standard care with Ekso group.Once a week, each participant will receive backward walking training with EksoNR during their treatment session.	Device: Gait training with EksoNR; Participants will receive forward gait training with EksoNR; Procedure: Backward gait training with EksoNR; Participants will receive backward gait training with EksoNR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in backward gait speed	Changes from baseline backward gait speed measured by 3-Meter Backwards Walk Test at post-intervention	Baseline and within 1 week after the intervention
Changes in forward gait speed	Changes from baseline forward gait speed measured by 6-Minute Walk Test at post-intervention	Baseline and within 1 week after the intervention
Changes in Functional Ambulation Category	Changes from baseline ambulation ability at post-intervention. Functional Ambulation Category ranges from 0-5, and a higher score indicates a better outcome (greater independence in ambulation).	Baseline and within 1 week after the intervention
Changes in Berg Balance Scale	Changes from baseline static balance and fall risk at post-intervention. Berg Balance Scale ranges from 0 to 56, and a higher score indicates a better outcome (better balance and lower fall risk).	Baseline and within 1 week after the intervention
Changes in Patient Health Questionnaire-9	Changes from baseline depressive symptoms at post-intervention. Patient Health Questionnaire-9 ranges from 0 to 27, and a higher score indicates a worse outcome (greater depressive symptoms).	Baseline and within 1 week after the intervention
Changes in reciprocal activities in antagonistic muscles measured by Electromyography	Changes from baseline neuromuscular control of leg muscles at post-intervention. A greater reciprocity between leg antagonistic muscles indicate a better outcome.	Baseline and within 1 week after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to physical therapy	Adherence to physical therapy is defined as ≥ 80% attendance to weekly physical therapy as recorded in the Data Collection Sheet. Based on the definition, patient adherence will be considered a dichotomous variable (yes/no) and will be used to test the association between health literacy and patient adherence.	During the intervention
Level of health literacy	Level of health literacy is measured by Newest Vital Sign. The Newest Vital Sign 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, available from Pfizer Pharmaceutical Company. The score ranges 0-6. A score of 0-1 suggests a high likelihood of limited literacy, a score of 2-3 indicates the possibility of limited literacy, and a score of 4-6 almost always indicates adequate literacy.	Baseline
Perceived Social Support	Level of perceived social support is measured by Multidimensional Scale of Perceived Social Support. It is a self-administered scale, and the score ranges from 12 to 84. A score of 12-35 suggests a low perceived social support, a score of 36-60 suggests a medium social support, and a score of 61-84 suggests a high social support.	Baseline
Educational attainment	Each participant's answer regarding their educational level in the Demographics Questionnaire will be classified into one of the two categories: individuals who completed some college education and individuals whose highest educational attainment was high school or less. This dichotomous variable will be used to determine if the level of educational attainment is associated with adherence to physical therapy.	Baseline
Language spoken at home	Each participant's answer regarding the language spoken at home in the Demographics Questionnaire will be classified into one of the two categories: individuals who speak English at home and individuals who speak other languages than English at home. This dichotomous variable will be used to determine if linguistic proficiency is associated with adherence to physical therapy.	Baseline

Collaborators and Investigators

• Sponsor: Alvernia University
• Collaborators: The Reading Hospital and Medical Center
• Investigators: Principal Investigator: Soo Yeon Sun, Alvernia University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Estimated): December 25, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Robotic exoskeleton; Backward gait training; Forward gait training
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: IRB 052-21

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: Yes
• product manufactured in and exported from the U.S.: No