Clinical trial NCT05133362: Effects of Backward Gait Training with Exoskeleton on Motor Functions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Hemiplegic
Physical Therapy
Keywords: Robotic exoskeleton
Backward gait training
Forward gait training
Lead sponsor: Alvernia University
Sponsor class: OTHER
Collaborators: name: The Reading Hospital and Medical Center
First posted: 2021-11-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in backward gait speed
timeFrame: Baseline and within 1 week after the intervention
measure: Changes in forward gait speed
timeFrame: Baseline and within 1 week after the intervention
measure: Changes in Functional Ambulation Category
timeFrame: Baseline and within 1 week after the intervention
measure: Changes in Berg Balance Scale
timeFrame: Baseline and within 1 week after the intervention
measure: Changes in Patient Health Questionnaire-9
timeFrame: Baseline and within 1 week after the intervention
measure: Changes in reciprocal activities in antagonistic muscles measured by Electromyography
timeFrame: Baseline and within 1 week after the intervention
Secondary outcomes:
Other outcomes:
measure: Adherence to physical therapy
timeFrame: During the intervention
measure: Level of health literacy
timeFrame: Baseline
measure: Perceived Social Support
timeFrame: Baseline
measure: Educational attainment
timeFrame: Baseline
measure: Language spoken at home
timeFrame: Baseline
Locations:
city: Schenectady
country: United States
facility: Sunnyview Rehabilitation Hospital
state: New York
city: Reading
country: United States
facility: Reading Hospital Rehabilitation at Wyomissing
state: Pennsylvania
Study officials:
affiliation: Alvernia University
name: Soo Yeon Sun
role: PRINCIPAL_INVESTIGATOR
References: