OsteoporosisNCT02533713

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

A study testing Exoskeleton assisted gait training in people with Osteoporosis, run by Craig Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoporosis
What is being tested?: Exoskeleton assisted gait training
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 23 Jun 2017to 10 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

3 years or more after injury
Motor complete SCI (AIS A and B) or AIS C or D who are non-ambulatory
SCI C07-T12
155-191 centimeters tall
Weigh less than 113 kilograms
Have a Modified Ashworth Scale (MAS) score of less than 3 in both lower extremities
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.

Who cannot join

Current enrollment in another clinical trial
Pregnancy
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)

Show all 10Show fewer

Active treatment for epilepsy or thyroid disorders
Current use of medications potentially affecting bone health (bisphosphonates, androgenic steroids, estrogenic steroids, lithium, glucocorticoid use for more than 3 months)
Women with osteoporosis detected at baseline DXA testing due to the high rate of study-related fractures observed in this group
Subjects with MRI-incompatible implants, pumps, or neurostimulators may be enrolled but will not undergo MRI studies

Trial locations and contacts

1 site in 1 country.

United States1 site

Craig Hospital
Englewood, Colorado, 80113

Other trials in United States

About this study

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

This is a randomized clinical trial to quantify the effects of exoskeleton-assisted gait on the musculoskeletal system and health-related quality of life.

Read the 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.

Conditions: Osteoporosis
Being tested: Exoskeleton assisted gait training
Keywords: rehabilitation, bone strength, quality of life
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Exoskeleton assisted gait trainingDevice
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).

Study groups in NCT02533713
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Exoskeleton assisted gait training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Tibial Stiffness
Assessed by finite element analysis of quantitative CT scan (QCT) of the knee, values indicate measured epiphysis compressive strength index
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

Secondary outcomes (8)

Change in Bone Volume
Assessed by quantitative CT scan (QCT) of the knee, values indicate measured epiphysis cortical bone volume
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Mood
Assessed by Patient Health Questionnaire-9 (PHQ-9) contains 9 items, with total scores ranging from 0 (none to minimal depression) to 27 (severe depression).
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Pain
Assessed by International Spinal Cord Injury Basic Pain Data Set, standardize the collection and reporting of pain and its interference in the SCI population. A composite score of 3 items on pain interference, with total score ranging from 0 (pain has no interference) to 10 (pain has extreme interference).
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Cortical Activity
Assessed by brain magnetic resonance imaging (MRI), values indicate measured cortical activity from right caudate to right central operculum and insular. The reported metric is the beta-estimate of the connectivity between the caudate (seed region) and the right central operculum. Higher beta-estimate equate to more connectivity between the two regions.
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 1
Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 1 reports on the physical health, with raw score ranging from 7-35, and transformed scores to a 0-100 point interval. Higher scores (raw=35, transformed=100) correspond to greater perceived quality of life pertaining to physical health.
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 2
Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 2 reports on the psychological health, with raw score ranging from 6-30, and transformed scores to a 0-100 point interval. Higher scores (raw=30, transformed=100) correspond to greater perceived quality of life pertaining to psychological health.
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 3
Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 3 reports on the social relationship, with raw score ranging from 3-15, and transformed scores to a 0-100 point interval. Higher scores (raw=15, transformed=100) correspond to greater perceived quality of life pertaining to social relationship.
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 4
Assessed by psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Domain 4 reports on the participant's environment, with raw score ranging from 8-40, and transformed scores to a 0-100 point interval. Higher scores (raw=40, transformed=100) correspond to greater perceived quality of life pertaining to participant's environment.
Measured: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 201710 Dec 2021

First posted27 Aug 2015 (estimated)
Study start23 Jun 2017
Primary completion10 Dec 2021
Study completion10 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02533713
Sponsor's protocol ID: 2015P001535
Other IDs: CDMRP-SC140251
Status last verified: Aug 2026
First submitted: 21 Aug 2015
Last updated: 2 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34717922

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Exoskeleton-Assisted Gait Training on Bone Health and Quality of Life: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02533713
Acronym / sponsor ID: 2015P001535
Conditions: Osteoporosis
Keywords: rehabilitation, bone strength, quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Craig HospitalUniversity, hospital or other
Collaborators: Worcester Polytechnic Institute, Massachusetts General Hospital, University of Colorado, Denver, University of Minnesota, Congressionally Directed Medical Research Programs
Study start: 23 Jun 2017 (actual)
Primary completion: 10 Dec 2021 (actual)
Study completion: 10 Dec 2021 (actual)
First posted: 27 Aug 2015 (estimated)
Results: Posted 2 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate gait training	Experimental	Device: Exoskeleton assisted gait trainingParticipants 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	Other	Device: Exoskeleton assisted gait trainingParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

3 years or more after injury
Motor complete SCI (AIS A and B) or AIS C or D who are non-ambulatory
SCI C07-T12
155-191 centimeters tall
Weigh less than 113 kilograms

Key exclusion criteria (10 listed)

Current enrollment in another clinical trial
Pregnancy
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exoskeleton assisted gait trainingGait 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).	Device	Delayed gait training, Immediate gait training

Primary outcome

Change in Tibial Stiffness
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Assessed by finite element analysis of quantitative CT scan (QCT) of the knee, values indicate measured epiphysis compressive strength index

8 secondary outcomes

Change in Bone Volume
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Mood
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Pain
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Cortical Activity
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 1
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 2
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 3
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)
Change in Health-related Quality of Life, Domain 4
Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)

Results and safety

Results posted to the registry on 2 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate Gait Training	33	13
Delayed Gait Training	27	6

Primary outcome: Change in Tibial Stiffness

Time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm). Mean (Standard Deviation). Unit: g(^2)/cm(^4)

Measure	Immediate Gait Training n = 13	Delayed Gait Training n = 6
Pre Gait Training	0.20 (0.12)	0.25 (0.15)
Post Gait Training	0.22 (0.15)	0.27 (0.15)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was tracked and collected from each participant's time of enrollment through their end of study, an average of 13 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Gait Training	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Delayed Gait Training	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34717922Kowalski 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie R Morse, DO principal investigator

Craig Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exoskeleton assisted gait training in people with Osteoporosis, run by Craig Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tibial Stiffness (time frame: Pre Gait Training (baseline for Immediate Gait Training Arm and 6 months post baseline for Delayed Gait Training Arm), Post Gait Training (6 months post baseline for Immediate Gait Training Arm and 12 months post baseline for Delayed Gait Training Arm)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02533713, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.