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

March 20, 2017 updated by: Gail Forrest, Kessler Foundation
The purpose of this research study is to evaluate an exoskeleton device and mobility skills in the device.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Currently, the treatment of muscle and bone deterioration after SCI is very limited; therefore, there is a definite need to further understand the mechanism of breakdown in the musculoskeletal system after a SCI, and, more importantly, find a clinical strategy that will treat muscle and bone loss.

This pilot research grant will collect results that will be used for the design of a multi-site randomized controlled clinical trial to determine whether a Robotic Exoskeleton training [100 sessions; 1hr/session; 4-5 sessions/week] can improve musculoskeletal outcomes more than other current interventions. If the overall objective is to use the progression of technology to enhance functional ambulation for persons with a spinal cord injury, then the investigators need to evaluate the health benefits associated with continual use of the device.

The study will be a prospective, single-group, repeated measure design using a 2 -month lead in to establish stability, 5-month intervention phase and 2 -month follow-up phase for retention will be performed. Each participant will be used as his or her own control. This project will be completed at two sites: Kessler Foundation will be the lead site that will be under the direction of Dr. Gail F Forrest (Principal Investigator) and Spinal Cord Damage Research Center, James J Peters VA Medical Center under the direction of Dr. Ann M. Spungen (collaborator). Both sites have exoskeletal-assisted walking programs.

Study Type

Interventional

Enrollment (Anticipated)

13

Phase

  • 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

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

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be a non walker with a SCI greater than 1 year post injury
  • Must have a neurological level between the C6-T10 level
  • Must have a lower extremity score greater than 1 as defined by the neurological exam
  • Must be between 21 and 45 years old
  • Must be wheelchair reliant 100% of time
  • Must have knee bone mineral density greater than .5755 gm/cm2 as determined by study staff
  • Must have a score on the Modified Ashworth Scale equal to or less than 3 as determined by the study staff
  • Must be able to tolerate upright standing for up to 30 minutes
  • Must have joint range of motion within normal functional limits for ambulation
  • Must have sufficient upper body strength to balance using the walker while wearing the exoskeleton
  • Must have a height between 62 inches or 74 inches
  • Must weigh less than 220 lbs,(limitation of the devices)
  • Must have no joint tightening of any extremity that limits movement during walking with the assistive devices
  • Must have no medical issue that precludes full weight bearing, ambulation or exercise intolerance in the exoskeleton (e.g. orthopedic injuries, pain, severe spasticity)
  • Must have no skin issues (e.g. pressure sores) that would prevent wearing the device
  • Must have no memory and/or thinking disability (e.g. due to brain injury)
  • Must be able to follow directions well and demonstrate learning capability
  • Must be able to physically fit into the exoskeletal device

Exclusion Criteria:

  • A woman who is pregnant, lactating, or post-menopausal
  • Wearing an external device that supports the spinal column or the head, neck, or trunk
  • Have persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in robotic system)
  • Have had a hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study or no presence of major cardiovascular or pulmonary disease, lower extremity deep vein thrombosis (within the last three months)
  • Have been taking any medications known to influence bone metabolism

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exoskeleton training

To examine the effectiveness of robotic exoskeleton-assisted over ground walking (5 hrs. p/wk, 100 sessions, 20 wks = 100 hrs) to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI. Combined with our current training protocol where people step 1500-2000/session we predict that the 2,000 lower extremity muscle contractions will be sufficient in our proposed exoskeletal study.

MRI's will be performed to accurately assess muscle CSA of each lower limb to determine individual's muscle thigh and shank volume.

Muscle Biopsies for the quadricep muscle will be performed to determine changes in BMD and bone structure due to intensive exoskeleton assisted walking.
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 Names:
  • Ekso
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 Names:
  • Needle Biopsies
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.
Time Frame: 100 hours
To examine the effectiveness of exoskeleton assisted overground walking (5 hours per week, 100 sessions, 20 weeks = 100 hours) to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI.
100 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Activation
Time Frame: 100 hours
To examine the effect of exoskeletal assisted walking for 100 sessions in increasing further muscle volume through muscle activation to increase muscle size and strength and mitigate the secondary complications that follow SCI.
100 hours

Collaborators and Investigators

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

Sponsor

Kessler Foundation

Collaborators

New Jersey Commission on Spinal Cord Research

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

October 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSCR131RG013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Spinal Cord Injury

Clinical Trials on Exoskeleton Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe