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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02533713
• Other study ID #: 2015P001535
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: December 1, 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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).

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
Craig Hospital	Massachusetts General Hospital, University of Colorado, Denver, University of Minnesota, Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in bone formation	assessed by circulating osteocalcin level	baseline, six months, and 12 months
Other	Change in marrow adiposity	Assessed by quantitative cat scan of the knee	baseline, six months, and 12 months
Other	change in bone resorption	assessed by circulating c-telopeptide level	baseline, six months, and 12 months
Primary	Change in tibial stiffness	assessed by finite element analysis of quantitative cat scan (QCT) of the knee	baseline, six months, and 12 months
Secondary	Change in bone Volume	quantitative cat scan of the knee	baseline, six months, and 12 months
Secondary	Change in mood	Patient Health Questionnaire-9	baseline, six months, and 12 months
Secondary	Change in pain	International Spinal Cord Injury Basic Pain Data Set	baseline, six months, and 12 months
Secondary	Change in cortical activity	assessed by brain magnetic resonance imaging (MRI)	baseline, six months, and 12 months
Secondary	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