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.
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
Allocation
RANDOMIZED
Purpose
Participants will receive forward gait training with EksoNR
Participants will receive backward gait training with EksoNR
Sunnyview Rehabilitation Hospital
Schenectady, New York, United States
Reading Hospital Rehabilitation at Wyomissing
Reading, Pennsylvania, United States
Changes in backward gait speed
Changes from baseline backward gait speed measured by 3-Meter Backwards Walk Test at post-intervention
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline and within 1 week after the intervention
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TREATMENT
Masking
SINGLE
Enrollment
9