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

Not Applicable

• Conditions: Osteoporosis
• Interventions: Device: Exoskeleton assisted gait training

• Registration Number: NCT02533713
• Lead Sponsor: Craig Hospital

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.

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 Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Study Start: 2017-07-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-08
• Primary Completion: 2022-10
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate gait training	Exoskeleton assisted 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.
Delayed gait training	Exoskeleton assisted 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.

Primary Outcome Measures

Name	Time	Method
Change in tibial stiffness	baseline, six months, and 12 months	assessed by finite element analysis of quantitative cat scan (QCT) of the knee

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Craig Hospital; 🇺🇸 Englewood, Colorado, United States