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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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

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,
  • 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.

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: baseline, six months, and 12 months

    assessed by finite element analysis of quantitative cat scan (QCT) of the knee

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Collaborators

  • 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
2022
Study completion
2022
First posted
Aug 27, 2015
Registry last updated
Dec 8, 2021

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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