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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

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring rehabilitation, bone strength, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

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

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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