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

Study Overview
=================
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.

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

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Device: Exoskeleton assisted gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate gait training<br>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<br>* 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).<br>|
| Other: Delayed gait training<br>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<br>* 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).<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rehabilitation, bone strength, quality of life