Effects of Backward Gait Training With Exoskeleton on Motor Functions

Not Applicable

Terminated

• Conditions: Gait, Hemiplegic; Physical Therapy

• Registration Number: NCT05133362
• Lead Sponsor: Alvernia University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Study Start: 2022-08-25
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Berg Balance Scale	Baseline and within 1 week after the intervention	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).
Changes in Functional Ambulation Category	Baseline and within 1 week after the intervention	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).
Changes in Patient Health Questionnaire-9	Baseline and within 1 week after the intervention	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).
Changes in backward gait speed	Baseline and within 1 week after the intervention	Changes from baseline backward gait speed measured by 3-Meter Backwards Walk Test at post-intervention
Changes in reciprocal activities in antagonistic muscles measured by Electromyography	Baseline and within 1 week after the intervention	Changes from baseline neuromuscular control of leg muscles at post-intervention. A greater reciprocity between leg antagonistic muscles indicate a better outcome.
Changes in forward gait speed	Baseline and within 1 week after the intervention	Changes from baseline forward gait speed measured by 6-Minute Walk Test at post-intervention

Trial Locations

Locations (2)

Sunnyview Rehabilitation Hospital; 🇺🇸 Schenectady, New York, United States

Reading Hospital Rehabilitation at Wyomissing; 🇺🇸 Reading, Pennsylvania, United States