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Completed

NCT Number: NCT02533713

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

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3 years or more after injury
  • Motor complete SCI (AIS A and B) or AIS C or D who are non-ambulatory
  • SCI C07-T12
  • 155-191 centimeters tall
  • Weigh less than 113 kilograms
  • Have a Modified Ashworth Scale (MAS) score of less than 3 in both lower extremities
  • 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
  • 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 or thyroid disorders
  • Current use of medications potentially affecting bone health (bisphosphonates, androgenic steroids, estrogenic steroids, lithium, glucocorticoid use for more than 3 months)
  • Women with osteoporosis detected at baseline DXA testing due to the high rate of study-related fractures observed in this group
  • Subjects with MRI-incompatible implants, pumps, or neurostimulators may be enrolled but will not undergo MRI studies

Treatment and study plan

Exoskeleton assisted gait training

Device

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).

Primary outcomes

  1. Change in Tibial Stiffness

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by finite element analysis of quantitative CT scan (QCT) of the knee, values indicate measured epiphysis compressive strength index

Secondary outcomes

  1. Change in Bone Volume

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by quantitative CT scan (QCT) of the knee, values indicate measured epiphysis cortical bone volume

  2. Change in Mood

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by Patient Health Questionnaire-9 (PHQ-9) contains 9 items, with total scores ranging from 0 (none to minimal depression) to 27 (severe depression).

  3. Change in Pain

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by International Spinal Cord Injury Basic Pain Data Set, standardize the collection and reporting of pain and its interference in the SCI population. A composite score of 3 items on pain interference, with total score ranging from 0 (pain has no interference) to 10 (pain has extreme interference).

  4. Change in Cortical Activity

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by brain magnetic resonance imaging (MRI), values indicate measured cortical activity from right caudate to right central operculum and insular. The reported metric is the beta-estimate of the connectivity between the caudate (seed region) and the right central operculum. Higher beta-estimate equate to more connectivity between the two regions.

  5. Change in Health-related Quality of Life, Domain 1

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 1 reports on the physical health, with raw score ranging from 7-35, and transformed scores to a 0-100 point interval. Higher scores (raw=35, transformed=100) correspond to greater perceived quality of life pertaining to physical health.

  6. Change in Health-related Quality of Life, Domain 2

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 2 reports on the psychological health, with raw score ranging from 6-30, and transformed scores to a 0-100 point interval. Higher scores (raw=30, transformed=100) correspond to greater perceived quality of life pertaining to psychological health.

  7. Change in Health-related Quality of Life, Domain 3

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 3 reports on the social relationship, with raw score ranging from 3-15, and transformed scores to a 0-100 point interval. Higher scores (raw=15, transformed=100) correspond to greater perceived quality of life pertaining to social relationship.

  8. Change in Health-related Quality of Life, Domain 4

    Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

    Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 4 reports on the participant's environment, with raw score ranging from 8-40, and transformed scores to a 0-100 point interval. Higher scores (raw=40, transformed=100) correspond to greater perceived quality of life pertaining to participant's environment.

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • Massachusetts General Hospital
  • University of Colorado, Denver
  • University of Minnesota
  • Worcester Polytechnic Institute

Registry information

Official study title

Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life: A Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2015
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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