Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life
NCT ID: NCT02533713
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
36 participants
INTERVENTIONAL
2017-07-01
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Worcester Polytechnic Institute
OTHER
Massachusetts General Hospital
OTHER
University of Colorado, Denver
OTHER
University of Minnesota
OTHER
Craig Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Leslie Morse
Medical Director of Research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Leslie R Morse, DO
Role: PRINCIPAL_INVESTIGATOR
Craig Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Craig Hospital
Englewood, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015P001535
Identifier Type: -
Identifier Source: org_study_id