Effects of Backward Gait Training With Exoskeleton on Motor Functions

Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133362
• Other study ID #: IRB 052-21
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Alvernia University
• Contact: Soo Yeon Sun, PhD
• Phone: 6107968398
• Email: soo.sun[@]alvernia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: June 30, 2025
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Physical Therapy

Intervention

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

Locations

Country	Name	City	State
United States	Reading Hospital Rehabilitation at Wyomissing	Reading	Pennsylvania
United States	Sunnyview Rehabilitation Hospital	Schenectady	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alvernia University	The Reading Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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