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Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI (EAWSCI)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT02314221
First received: December 2, 2014
Last updated: August 21, 2017
Last verified: August 2017
  Purpose

The primary objective of this study is to achieve successful walking skills using exoskeletal walking devices over the course of 36 sessions in 3 months at specific velocities and distances in people with chronic SCI who are wheelchair dependent for community mobility. The secondary objectives are to determine if this amount of exoskeletal walking is effective in improving bowel function and body composition in the same patient population. The exploratory objectives are to address additional questions concerning the retention or non-retention of the positive changes, the effects of the increased physical activity from this intervention on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels, and quality of life (QOL).

A Phase III randomized clinical trial (RCT) will be performed using a crossover design and employing an exoskeletal-assisted walking intervention. The experimental arm will be compared to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (>6 month post injury) who are wheelchair-dependent for outdoor mobility in the community. The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions for their second 12-week period. The UA arm will consist of identification of usual activities for each participant, encouragement to continue with these activities and attention by study team members throughout the 12-week UA arm. These activities will be recorded in a weekly log. The investigators hypotheses are that 1) this exoskeletal intervention will be successful in training ambulatory skills in this patient population, 2) the exoskeletal intervention will be better than a control group in improving body composition, bowel function, metabolic parameters and quality of life in the same population.


Condition Intervention
Spinal Cord Injury Paraplegia Tetraplegia Device: Exoskeletal-assisted walking (ReWalk, Ekso)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Crossover Clinical Trial of Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI

Resource links provided by NLM:


Further study details as provided by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center:

Primary Outcome Measures:
  • 10meter Walk Test [ Time Frame: Sessions 12 (1 month) ]
    Number of participants completing the 10m Walk Test in less than 60 seconds

  • 6min Walk Test [ Time Frame: Session 12 (1 month) ]
    Percentage of participants achieving distance of greater than 50m in 6min

  • Timed-Up-and-Go Test (TUG) [ Time Frame: Session 12 (1 month) ]
    Percentage of participants completing the TUG in less than 120 seconds

  • Advanced Walking Skills [ Time Frame: Session 36 (Three months) ]
    By session 36, participants will have improved their ability to walk with or without minimal assistance


Secondary Outcome Measures:
  • Bowel Function [ Time Frame: 36 sessions (Three months) ]
    To improve bowel function as measured by established survey instruments

  • Total body fat mass [ Time Frame: 36 sessions (Three months) ]
    To reduce total body fat mass and percent as measured by DXA.


Estimated Enrollment: 64
Study Start Date: February 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exoskeletal-Assisted Walking (WALK)
WALK first for 12 weeks (36 sessions)
Device: Exoskeletal-assisted walking (ReWalk, Ekso)
The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions (12 weeks) and usual activities for their second 12-week period.
Other Names:
  • ReWalk
  • Ekso
No Intervention: Usual Activities (UA)
Usual activities first for 12 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, between 18-70 years old
  • Traumatic or non-traumatic paraplegia >6 months in duration
  • SCI motor deficit at any level
  • Unable to ambulate faster than 0.17 m/s on level ground with or without an assistive device and are wheelchair-dependent for community mobility
  • Height 160 to 190 cm (63-75 in or 5'3" to 6'3" ft)
  • Weight <100 kg (<220 lb)
  • Able to hold the crutches
  • Able to sign informed consent.

Exclusion Criteria:

  • Diagnosis of neurological injury other than SCI including:
  • Multiple sclerosis, Stroke, Cerebral Palsy, Amyotrophic lateral sclerosis, Traumatic Brain injury, Spina bifida, Parkinson's disease, or
  • Other neurological condition that the study physician considers in his/her clinical judgment to be exclusionary
  • Severe concurrent medical disease, illness or condition
  • Recent lower extremity fracture within the past 2 years
  • DXA results indicating a t-score below -3.5 at the femoral neck or the total proximal femur bone and knee BMD <0.60 gm/cm2
  • Diagnosis of heterotropic ossification of the lower extremities which affect range of motion or proper measurement of BMD measurements
  • Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee
  • Untreated hypertension (SBP>140, DBP>90 mmHg)
  • Symptomatic orthostatic hypotension with standing that does not resolve after attempts at upright posture that were made over several days, and standing by the participant is deemed to pose a health risk, as determined by a physician, because of symptomatic orthostatic hypotension
  • Systemic or peripheral infection
  • Atherosclerosis, congestive heart failure, or history of myocardial infarction;
  • Trunk and/or lower extremity pressure ulcers
  • Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician or physical therapist)
  • Significant contractures defined as flexion contracture limited to 25º at the hip and knee
  • Diagnosis of heterotropic ossification of the lower extremities which affect range of motion or proper measurement of BMD measurements
  • Psychopathology documentation in the medical record or history of that may conflict with study objectives
  • Pregnancy and/or lactating females
  • Brain injury with score on mini-mental status examination less than 26
  • Diagnosis of coronary artery disease that precludes moderate to intense exercise
  • Deep vein thromboses in lower extremities of less than 6 months duration
  • Other illness, that the study physician considers in his/her clinical judgment to be exclusionary.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02314221

Contacts
Contact: Steve Knezevic, MS 718-584-9000 ext 3130 steven.knezevic@va.gov
Contact: Pierre K Asselin, MS 718-584-9000 ext 3124 pierre.asselin@va.gov

Locations
United States, Maryland
Univerity of Maryland rehabilitation and Orthopaedic Institute (UMROI) Recruiting
Baltimore, Maryland, United States, 21201
Contact: Leigh Casey    410-448-6773    lcasey@umm.edu   
Principal Investigator: Peter Gorman, MD         
United States, New Jersey
Kessler Foundation Research Center (KFRC) Recruiting
West Orange, New Jersey, United States, 07052
Contact: Leighann Martinez    973-324-3557    LMartinez@kesslerfoundation.org   
Principal Investigator: Gail F. Forrest, PhD         
United States, New York
James J Peteres VA Medical Center Recruiting
The Bronx, New York, United States, 10468
Contact: Steve Knezevic, MS    718-584-9000 ext 3130    steven.knezevic@va.gov   
Principal Investigator: Ann M Spungen, EdD         
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center
Investigators
Principal Investigator: Ann M Spungen, EdD James J Peters VAMC
  More Information

Responsible Party: Ann M. Spungen, EdD, VA Research Scientist, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02314221     History of Changes
Other Study ID Numbers: SPU-14-031
Study First Received: December 2, 2014
Last Updated: August 21, 2017

Keywords provided by Ann M. Spungen, EdD, James J. Peters Veterans Affairs Medical Center:
Exoskeletal-assisted walking

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Paraplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017