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

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ClinicalTrials.gov Identifier: NCT02324322
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
New Jersey Commission on Spinal Cord Research
Information provided by (Responsible Party):
Gail Forrest, Kessler Foundation

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Exoskeleton Training Other: Muscle Biopsies Other: MRI Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
Study Start Date : October 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324322


Contacts
Contact: Gail F Forrest, PhD 973-324-3518 ext 3518 gforrest@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Gail F Forrest, Ph.D    973-324-3518    gforrest@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
New Jersey Commission on Spinal Cord Research
Investigators
Principal Investigator: Gail F Forrest, PhD Kessler Foundation

Responsible Party: Gail Forrest, Principal Investigator, Kessler Foundation
ClinicalTrials.gov Identifier: NCT02324322     History of Changes
Other Study ID Numbers: CSCR131RG013
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Gail Forrest, Kessler Foundation:
Device: Robotic Exoskeleton

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries