Effects of Backward Gait Training With Exoskeleton on Motor Functions

NCT05133362 | Terminated DMC FDA Device

• 1 other identifier: IRB 052-21
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Gait, Hemiplegic; Physical Therapy

Keywords

Robotic exoskeleton; Backward gait training; Forward gait training

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Other Outcomes (5)

• Adherence to physical therapy

  During the intervention

• Level of health literacy

  Baseline

• Perceived Social Support

  Baseline

Study Arms (2)

Standard Care with Ekso Group

ACTIVE COMPARATOR

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.

Device: Gait training with EksoNR

Standard Care with Ekso and Backward Walking Group

EXPERIMENTAL

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.

Device: Gait training with EksoNR; Procedure: Backward gait training with EksoNR

Interventions

Gait training with EksoNR DEVICE

Participants will receive forward gait training with EksoNR

Standard Care with Ekso Group; Standard Care with Ekso and Backward Walking Group

Backward gait training with EksoNR PROCEDURE

Participants will receive backward gait training with EksoNR

Standard Care with Ekso and Backward Walking Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alvernia University: lead
• The Reading Hospital and Medical Center: collaborator

Study Sites (2)

Sunnyview Rehabilitation Hospital

Schenectady, New York, 12308, United States

Location

Reading Hospital Rehabilitation at Wyomissing

Reading, Pennsylvania, 19610, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Soo Yeon Sun

  Alvernia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: August 25, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 11, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)