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

NCT02324322 | Unknown DMC

• 1 other identifier: CSCR131RG013
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Cord Injury

Keywords

Device: Robotic Exoskeleton

Outcome Measures

Primary Outcomes (1)

• Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.

  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 Outcomes (1)

• Muscle Activation

  100 hours

Study Arms (1)

Exoskeleton training

EXPERIMENTAL

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; Other: Muscle Biopsies; Other: MRI

Interventions

Exoskeleton Training DEVICE

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.

Also known as: Ekso

Exoskeleton training

Muscle Biopsies OTHER

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.

Also known as: Needle Biopsies

Exoskeleton training

MRI OTHER

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.

Exoskeleton training

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead
• New Jersey Commission on Spinal Cord Research: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Gail F Forrest, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail F Forrest, PhD

CONTACT

973-324-3518; gforrest@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 24, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)