Osteoporosis
Conditions
Keywords
rehabilitation, bone strength, quality of life
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.
Interventions
DEVICEExoskeleton 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).
Sponsors
Craig Hospital
Worcester Polytechnic Institute
Massachusetts General Hospital
University of Colorado, Denver
University of Minnesota
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tibial Stiffness | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Volume | 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 |
| Change in Mood | 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). |
| Change in Pain | 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). |
| Change in Cortical Activity | 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. |
| Change in Health-related Quality of Life, Domain 1 | 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. |
| Change in Health-related Quality of Life, Domain 2 | 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. |
| Change in Health-related Quality of Life, Domain 3 | 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. |
| Change in Health-related Quality of Life, Domain 4 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeslie R Morse, DO
Craig Hospital
Participant flow
Pre-assignment details
1 participant consented and enrolled into the study but did not progress to randomization or complete any study activities (e.g. secondary screening, study testing).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 13.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 27 Participants |
| Tibial Stiffness | 0.19 g(^2)/cm(^4) STANDARD_DEVIATION 0.16 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 6 |
| other Total, other adverse events | 13 / 13 | 6 / 6 |
| serious Total, serious adverse events | 0 / 13 | 0 / 6 |
Outcome results
None listed