Clinical trial NCT02533713: Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life
Official title: Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: rehabilitation
bone strength
quality of life
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: Worcester Polytechnic Institute
name: Massachusetts General Hospital
name: University of Colorado, Denver
name: University of Minnesota
First posted: 2015-08-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in tibial stiffness
timeFrame: baseline, six months, and 12 months
Secondary outcomes:
measure: Change in bone Volume
timeFrame: baseline, six months, and 12 months
measure: Change in mood
timeFrame: baseline, six months, and 12 months
measure: Change in pain
timeFrame: baseline, six months, and 12 months
measure: Change in cortical activity
timeFrame: baseline, six months, and 12 months
measure: Change in health-related quality of life
timeFrame: baseline, six months, and 12 months
Other outcomes:
measure: Change in bone formation
timeFrame: baseline, six months, and 12 months
measure: Change in marrow adiposity
timeFrame: baseline, six months, and 12 months
measure: change in bone resorption
timeFrame: baseline, six months, and 12 months
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
affiliation: Craig Hospital
name: Leslie R Morse, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kowalski JL, Nguyen N, Battaglino RA, Falci SP, Charlifue S, Morse LR. miR-338-5p Levels and Cigarette Smoking are Associated With Neuropathic Pain Severity in Individuals With Spinal Cord Injury: Preliminary Findings From a Genome-Wide microRNA Expression Profiling Screen. Arch Phys Med Rehabil. 2022 Apr;103(4):738-746. doi: 10.1016/j.apmr.2021.09.005. Epub 2021 Oct 27.