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: Active, not recruiting
• 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 (Anticipated): 36
• 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
• Genders Eligible for Study: All

Description

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.

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 cat scan (QCT) of the knee	baseline, six months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bone Volume	quantitative cat scan of the knee	baseline, six months, and 12 months
Change in mood	Patient Health Questionnaire-9	baseline, six months, and 12 months
Change in pain	International Spinal Cord Injury Basic Pain Data Set	baseline, six months, and 12 months
Change in cortical activity	assessed by brain magnetic resonance imaging (MRI)	baseline, six months, and 12 months
Change in health-related quality of life	psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF)	baseline, six months, and 12 months

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
• 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): July 1, 2017
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; quality of life; bone strength
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 2015P001535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

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