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

NCT02533713 | Unknown FDA Device

• 1 other identifier: 2015P001535
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

rehabilitation; bone strength; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in tibial stiffness

  assessed by finite element analysis of quantitative cat scan (QCT) of the knee

  baseline, six months, and 12 months

Secondary Outcomes (5)

• Change in bone Volume

  baseline, six months, and 12 months

• Change in mood

  baseline, six months, and 12 months

• Change in pain

  baseline, six months, and 12 months

• Change in cortical activity

  baseline, six months, and 12 months

• Change in health-related quality of life

  baseline, six months, and 12 months

Other Outcomes (3)

• Change in bone formation

  baseline, six months, and 12 months

• Change in marrow adiposity

  baseline, six months, and 12 months

• change in bone resorption

  baseline, six months, and 12 months

Study Arms (2)

Immediate gait training

EXPERIMENTAL

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

Delayed gait training

OTHER

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

Interventions

Exoskeleton assisted gait training DEVICE

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; Immediate gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or more after injury,
• Non-ambulatory AIS A-D spinal cord injury (C7-T12),
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Craig Hospital: lead
• Worcester Polytechnic Institute: collaborator
• Massachusetts General Hospital: collaborator
• University of Colorado, Denver: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Related Publications (1)

• 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.

  PMID: 34717922 DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Leslie R Morse, DO

  Craig Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Research

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 27, 2015
• Study Start: July 1, 2017
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

US (1)