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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Device: Exoskeleton assisted gait training

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Craig Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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).
Other: 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.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tibial Stiffness	Assessed by finite element analysis of quantitative CT scan (QCT) of the knee, values indicate measured epiphysis compressive strength index	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bone Volume	Assessed by quantitative CT scan (QCT) of the knee, values indicate measured epiphysis cortical 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)
Change in Mood	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).	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)
Change in Pain	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).	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)
Change in Cortical Activity	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.	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)
Change in Health-related Quality of Life, Domain 1	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.	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)
Change in Health-related Quality of Life, Domain 2	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.	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)
Change in Health-related Quality of Life, Domain 3	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.	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)
Change in Health-related Quality of Life, Domain 4	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.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone formation	assessed by circulating osteocalcin level	baseline, six months, and 12 months
Change in marrow adiposity	Assessed by quantitative cat scan of the knee	baseline, six months, and 12 months
change in bone resorption	assessed by circulating c-telopeptide level	baseline, six months, and 12 months

Collaborators and Investigators

• Sponsor: Craig Hospital
• Collaborators: University of Colorado, Denver; Massachusetts General Hospital; University of Minnesota; Worcester Polytechnic Institute; Congressionally Directed Medical Research Programs
• Investigators: Principal Investigator: Leslie R Morse, DO, Craig Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimated): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; quality of life; bone strength
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis
• Other Study ID Numbers: 2015P001535; CDMRP-SC140251 (Other Grant/Funding Number: CDMRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes