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Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02533713
Recruitment Status : Active, not recruiting
First Posted : August 27, 2015
Last Update Posted : December 8, 2021
Sponsor:
Collaborators:
Worcester Polytechnic Institute
Massachusetts General Hospital
University of Colorado, Denver
University of Minnesota
Information provided by (Responsible Party):
Leslie Morse, Craig Hospital

Study Description
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Brief Summary:
This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on the musculoskeletal system and health-related quality of life.

Condition or disease Intervention/treatment Phase
Osteoporosis Device: Exoskeleton assisted gait training Not Applicable

Detailed Description:
Investigators will test if exoskeleton-assisted ambulation confers skeletal benefits in a dose-dependent fashion. Investigators also will test if reintroduction of ambulation will be associated with improvements in quality of life due to improvements in mood, pain, and functional connectivity of emotional networks in the brain.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life: A Randomized Clinical Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Immediate gait training
Participants assigned to this arm will begin Exoskeleton assisted gait training right away and will continue training for the first 6 months of the study.
 Device: Exoskeleton assisted gait training
Gait training will be performed 3 times a week for about an hour for 26 weeks. Gait training will be performed by a trained clinical physical therapist. The goal is to achieve 1 hour of continuous walking on a flat surface per training session. Gait training will continue for 26 weeks (78 sessions).
Delayed gait training
Participants assigned to this arm will not gait train for 6 months. They will engage in Exoskeleton assisted gait training for the last 6 months of the study.
 Device: Exoskeleton assisted gait training
Gait training will be performed 3 times a week for about an hour for 26 weeks. Gait training will be performed by a trained clinical physical therapist. The goal is to achieve 1 hour of continuous walking on a flat surface per training session. Gait training will continue for 26 weeks (78 sessions).


Outcome Measures
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Primary Outcome Measures :
  1. Change in tibial stiffness [ Time Frame: baseline, six months, and 12 months ]
    assessed by finite element analysis of quantitative cat scan (QCT) of the knee


Secondary Outcome Measures :
  1. Change in bone Volume [ Time Frame: baseline, six months, and 12 months ]
    quantitative cat scan of the knee

  2. Change in mood [ Time Frame: baseline, six months, and 12 months ]
    Patient Health Questionnaire-9

  3. Change in pain [ Time Frame: baseline, six months, and 12 months ]
    International Spinal Cord Injury Basic Pain Data Set

  4. Change in cortical activity [ Time Frame: baseline, six months, and 12 months ]
    assessed by brain magnetic resonance imaging (MRI)

  5. Change in health-related quality of life [ Time Frame: baseline, six months, and 12 months ]
    psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF)


Other Outcome Measures:
  1. Change in bone formation [ Time Frame: baseline, six months, and 12 months ]
    assessed by circulating osteocalcin level

  2. Change in marrow adiposity [ Time Frame: baseline, six months, and 12 months ]
    Assessed by quantitative cat scan of the knee

  3. change in bone resorption [ Time Frame: baseline, six months, and 12 months ]
    assessed by circulating c-telopeptide level


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 years or more after injury,
  • Non-ambulatory AIS A-D spinal cord injury (C7-T12),
  • 158-188 centimeters tall,
  • Weigh less than 100 kilograms,
  • Have a Modified Ashworth Scale (MAS) score of less than 3 in both lower extremities, and
  • Have sufficient upper body strength to complete sit to sit transfers.
  • Women of childbearing potential must agree to use contraceptive measures during participation in the study. They also will be required to have a negative pregnancy test (urine or serum) before receiving an imaging studies.

Exclusion Criteria:

  • Current enrollment in another clinical trial
  • Pregnancy
  • Anyone with an initial blood pressure>140/90 mmHg, orthostatic hypotension with symptomatic fall in blood pressure >30 mmHg when upright,
  • An active grade 2 or greater pressure ulcer that can be worsened by walking in the device,
  • Lower extremity contractures that interfere with the ability to wear the device,
  • An unhealed limb or pelvic bone fracture history of other neurological disease (e.g. stroke, peripheral neuropathy, myopathy),
  • Active treatment for epilepsy,
  • Current use of medications potentially affecting bone health (bisphosphonates, androgenic steroids, estrogenic steroids, lithium, glucocorticoid use for more than 3 months).
  • Subjects with MRI-incompatible implants, pumps, or neurostimulators will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533713


Locations
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United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Craig Hospital
Worcester Polytechnic Institute
Massachusetts General Hospital
University of Colorado, Denver
University of Minnesota
Investigators
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Principal Investigator: Leslie R Morse, DO Craig Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Leslie Morse, Medical Director of Research, Craig Hospital
ClinicalTrials.gov Identifier: NCT02533713    
Other Study ID Numbers: 2015P001535
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Leslie Morse, Craig Hospital:
rehabilitation
bone strength
quality of life
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases