NCT02533713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 23, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

September 2, 2026

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

4.5 years

First QC Date

August 21, 2015

Results QC Date

May 20, 2026

Last Update Submit

August 31, 2026

Conditions

Osteoporosis

Keywords

rehabilitationbone strengthquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in Tibial Stiffness

    Assessed by finite element analysis of quantitative CT scan (QCT) of the knee, values indicate measured epiphysis compressive strength index

    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

    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

    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

    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

    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

    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)

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Device: Exoskeleton assisted gait training

Interventions

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).

Delayed gait trainingImmediate gait training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or more after injury
  • Motor complete SCI (AIS A and B) or AIS C or D who are non-ambulatory
  • SCI C07-T12
  • 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.

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Related Publications (1)

  • 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.

    PMID: 34717922DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Leslie Morse
Organization
University of Miami
lesliemorse@miami.edu
305-243-9227

Study Officials

  • Leslie R Morse, DO

    Craig Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Research

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 27, 2015

Study Start

June 23, 2017

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

September 2, 2026

Results First Posted

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)