Effects of Backward Gait Training With Exoskeleton on Motor Functions

NCT ID: NCT05133362

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2024-09-30

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.

Conditions

Gait, Hemiplegic; Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Gait training with EksoNR

Intervention Type: DEVICE

Participants will receive forward gait training with EksoNR

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.

Group Type: EXPERIMENTAL

Gait training with EksoNR

Intervention Type: DEVICE

Participants will receive forward gait training with EksoNR

Backward gait training with EksoNR

Intervention Type: PROCEDURE

Participants will receive backward gait training with EksoNR

Interventions

Gait training with EksoNR

Participants will receive forward gait training with EksoNR

Intervention Type: DEVICE

Backward gait training with EksoNR

Participants will receive backward gait training with EksoNR

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Reading Hospital and Medical Center

OTHER

Sponsor Role: collaborator

Alvernia University

OTHER

Sponsor Role: lead

Responsible Party

Soo Yeon Sun, PT, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo Yeon Sun

Role: PRINCIPAL_INVESTIGATOR

Alvernia University

Locations

Sunnyview Rehabilitation Hospital

Schenectady, New York, United States

Reading Hospital Rehabilitation at Wyomissing

Reading, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB 052-21

Identifier Type: -

Identifier Source: org_study_id