RECRUITING

Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Ekso (Ekso Bionics) is a wearable exoskeleton that provides robotic support and walking assistance for patients with lower extremity paralysis. Research suggests that exoskeleton-assisted gait training is as effective as conventional gait training at improving walking outcomes and balance during both the chronic and subacute period following stroke (Goffredo et al., 2019; Molteni et al., 2017; Molteni et al., 2021; Nam et al., 2019; Rojek, 2019). Exoskeleton-assisted gait training during acute inpatient rehabilitation provides a means for patients to actively participate in gait training during the early and most severe stages of stroke recovery. Most acute inpatient rehabilitation facilities (IRFs) report a feasibility of 5-8 Ekso sessions during inpatient stays and demonstrate significant improvement from baseline (Nolan et al., 2020; Swank, 2020). Nolan et al. (2020) demonstrated that stroke patients receiving Ekso ambulated 1640 feet more than patients undergoing more conventional gait training techniques during inpatient rehabilitation, suggesting that the exoskeleton may offer additional benefit during this phase of recovery. Despite promising evidence, there have been no randomized controlled trials within the IRF setting. Because Ekso-gait training increases the number of steps patients can take, during acute inpatient physical therapy (PT), the investigators hypothesize that patients who participate in Ekso-gait training will demonstrate quicker improvements in balance, gait speed, endurance and independence in functional ambulation during their stay in the IRF. In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or Ekso-gait training therapy. Meaningful clinical benchmarks for balance and walking will be assessed using the Berg Balance Scale (BBS) (Alghadir, 2018; Moore, 2018), the 10 Meter Walk Test (10MWT) (Bowden, 2008; Moore, 2018), the Six Minute Walk Test (6MWT) (Kubo et al., 2020; Moore, 2018), and Functional Ambulation Category (FAC) (Mehrholz, 2007). Achieving these benchmark scores are associated with several positive outcomes, including increased ability to ambulate in the community and reduced risk of falling (Alghadir, 2018; Bowden, 2008; Kubo et al., 2020). The investigators also hypothesize that patients in the Ekso cohort will report greater value/usefulness when compared to patients receiving standard care.

Official Title

Achieving Meaningful Clinical Benchmarks With Ekso Gait Training During Acute Stroke Inpatient Rehabilitation.

Quick Facts

Study Start:2022-03-11
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05241457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Inpatient at Sunnyview Rehabilitation Hospital
  2. * Right or left hemispheric stroke
  3. * \>18 years of age
  1. * No paresis
  2. * Paraplegia
  3. * Quadriplegia
  4. * FAC of 2,3 or 4
  5. * Weight \> 220 lbs (Ekso manufacturer criteria)
  6. * Height \> 6'4" (Ekso manufacturer criteria)
  7. * \> 3 months post stroke onset
  8. * Comorbidities affecting gait (LE fractures, Parkinson's, Severe Polyneuropathy)
  9. * LE/sacral wounds that come into contact with the Ekso
  10. * LE contractures that cannot be accommodated by Ekso
  11. * Prior Stroke
  12. * Weight Bearing Restrictions 8
  13. * Unable to follow 1-2 step commands.
  14. * Contact precautions for COVID-19

Contacts and Locations

Study Contact

Amy Teale, PhD
CONTACT
518-386-3613
amy.teale@sphp.com
Erin Harmon, PhD
CONTACT
518-382-4520
erin.harmon@sphp.com

Principal Investigator

Karah Lenge, DPT
PRINCIPAL_INVESTIGATOR
Sunnyview Rehabilitation Hospital
Allison Tallon, DPT
PRINCIPAL_INVESTIGATOR
Sunnyview Rehabilitation Hospital

Study Locations (Sites)

Sunnyview
Schenectady, New York, 12308
United States

Collaborators and Investigators

Sponsor: Sunnyview Rehabilitation Hospital

  • Karah Lenge, DPT, PRINCIPAL_INVESTIGATOR, Sunnyview Rehabilitation Hospital
  • Allison Tallon, DPT, PRINCIPAL_INVESTIGATOR, Sunnyview Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-11
Study Completion Date2025-03

Study Record Updates

Study Start Date2022-03-11
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Exoskeleton
  • Gait training
  • Inpatient rehabilitation
  • Ekso gait training

Additional Relevant MeSH Terms

  • Stroke
  • Stroke, Acute
  • Cerebrovascular Accident
  • Cerebrovascular Accident, Acute