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Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle

NCT02324322 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-03-22

No results posted yet for this study

Summary

The purpose of this research study is to evaluate an exoskeleton device and mobility skills in the device.

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

Exoskeleton Training

Exoskeleton Training (100 sessions - 1 hour, 4 - 5 sessions per week for 20 weeks) to enhance functional ambulation for persons with a spinal cord injury. To examine the effectiveness of exoskeleton assisted overground walking to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI.

OTHER

Muscle Biopsies

Needle Biopsies for Quadricep Muscles will be performed to define changes in BMD and Bone structure with intensive exoskeleton assisted walking. This procedure includes having a trained physician make a small skin incision, after numbing the area over the muscle, and then removing a tiny sliver of muscle to study under the microscope. Three separate biopsies for one incision will be obtained. The biopsies will be performed at baseline, 7 days, and after the intervention. To define changes in biochemical markers of bone metabolism with intensive exoskeleton-assisted walking.

OTHER

MRI

MRI's will provide accurate assessments of muscle CSA of each lower limb (from above the origin of the iliopsoas to the insertion of the achilles tendon) to determine individual's muscle thigh and shank volume.

Sponsors & Collaborators

  • New Jersey Commission on Spinal Cord Research

    collaborator OTHER

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Gail F Forrest, PhD · Kessler Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02324322 on ClinicalTrials.gov