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

December 6, 2021 updated by: Leslie Morse, Craig Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Craig Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate 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.
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).
Other: Delayed 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.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in tibial stiffness
Time Frame: baseline, six months, and 12 months
assessed by finite element analysis of quantitative cat scan (QCT) of the knee
baseline, six months, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in bone Volume
Time Frame: baseline, six months, and 12 months
quantitative cat scan of the knee
baseline, six months, and 12 months
Change in mood
Time Frame: baseline, six months, and 12 months
Patient Health Questionnaire-9
baseline, six months, and 12 months
Change in pain
Time Frame: baseline, six months, and 12 months
International Spinal Cord Injury Basic Pain Data Set
baseline, six months, and 12 months
Change in cortical activity
Time Frame: baseline, six months, and 12 months
assessed by brain magnetic resonance imaging (MRI)
baseline, six months, and 12 months
Change in health-related quality of life
Time Frame: baseline, six months, and 12 months
psychological domain of the World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
baseline, six months, and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in bone formation
Time Frame: baseline, six months, and 12 months
assessed by circulating osteocalcin level
baseline, six months, and 12 months
Change in marrow adiposity
Time Frame: baseline, six months, and 12 months
Assessed by quantitative cat scan of the knee
baseline, six months, and 12 months
change in bone resorption
Time Frame: baseline, six months, and 12 months
assessed by circulating c-telopeptide level
baseline, six months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Craig Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
Massachusetts General Hospital
University of Minnesota
Worcester Polytechnic Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leslie R Morse, DO, Craig Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015P001535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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