Recruiting

Robotic Exoskeleton

Sponsor:

Kessler Foundation

Code:

NCT02324322

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Not accepted

Interventions

Exoskeleton Training

Muscle Biopsies

MRI

Study Details

Brief summary:

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

Conditions

Spinal Cord Injury

Study ID

NCT02324322

Start date

Oct, 2013

Status verified date

Mar, 2017

Completion date

Mar, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

13 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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 measure

  • Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement. [ Time Frame: 100 hours ]

Central Contacts and Locations

Central contacts

Gail F Forrest, PhD

973-324-3518gforrest@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Gail F Forrest, Ph.D

973-324-3518gforrest@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 22, 2017

Last verified

Mar, 2017

Keywords

  • Device: Robotic Exoskeleton

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2017-03-22.