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

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exoskeleton Training
Muscle Biopsies
MRI
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Device: Robotic Exoskeleton

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exoskeleton training

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Muscle Activation
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.

Full Information

First Posted
December 3, 2014
Last Updated
March 20, 2017
Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Spinal Cord Research
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1. Study Identification

Unique Protocol Identification Number
NCT02324322
Brief Title
Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
Official Title
Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Spinal Cord Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Device: Robotic Exoskeleton

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exoskeleton Training
Other Intervention Name(s)
Ekso
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Muscle Biopsies
Other Intervention Name(s)
Needle Biopsies
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
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 Information:
Title
Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.
Description
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.
Time Frame
100 hours
Secondary Outcome Measure Information:
Title
Muscle Activation
Description
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.
Time Frame
100 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gail F Forrest, PhD
Phone
973-324-3518
Ext
3518
Email
gforrest@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail F Forrest, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gail F Forrest, Ph.D
Phone
973-324-3518
Email
gforrest@kesslerfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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