Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life
Primary Purpose
Osteoporosis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exoskeleton assisted gait training
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring rehabilitation, bone strength, quality of life
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.
Sites / Locations
- Craig Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate gait training
Delayed gait training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in tibial stiffness
assessed by finite element analysis of quantitative cat scan (QCT) of the knee
Secondary Outcome Measures
Change in bone Volume
quantitative cat scan of the knee
Change in mood
Patient Health Questionnaire-9
Change in pain
International Spinal Cord Injury Basic Pain Data Set
Change in cortical activity
assessed by brain magnetic resonance imaging (MRI)
Change in health-related quality of life
psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Full Information
NCT ID
NCT02533713
First Posted
August 21, 2015
Last Updated
December 6, 2021
Sponsor
Craig Hospital
Collaborators
Worcester Polytechnic Institute, Massachusetts General Hospital, University of Colorado, Denver, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02533713
Brief Title
Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life
Official Title
Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital
Collaborators
Worcester Polytechnic Institute, Massachusetts General Hospital, University of Colorado, Denver, University of Minnesota
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
rehabilitation, bone strength, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate gait training
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed gait training
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exoskeleton assisted gait training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in tibial stiffness
Description
assessed by finite element analysis of quantitative cat scan (QCT) of the knee
Time Frame
baseline, six months, and 12 months
Secondary Outcome Measure Information:
Title
Change in bone Volume
Description
quantitative cat scan of the knee
Time Frame
baseline, six months, and 12 months
Title
Change in mood
Description
Patient Health Questionnaire-9
Time Frame
baseline, six months, and 12 months
Title
Change in pain
Description
International Spinal Cord Injury Basic Pain Data Set
Time Frame
baseline, six months, and 12 months
Title
Change in cortical activity
Description
assessed by brain magnetic resonance imaging (MRI)
Time Frame
baseline, six months, and 12 months
Title
Change in health-related quality of life
Description
psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
Time Frame
baseline, six months, and 12 months
Other Pre-specified Outcome Measures:
Title
Change in bone formation
Description
assessed by circulating osteocalcin level
Time Frame
baseline, six months, and 12 months
Title
Change in marrow adiposity
Description
Assessed by quantitative cat scan of the knee
Time Frame
baseline, six months, and 12 months
Title
change in bone resorption
Description
assessed by circulating c-telopeptide level
Time Frame
baseline, six months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie R Morse, DO
Organizational Affiliation
Craig Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34717922
Citation
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.
Results Reference
derived
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Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life
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