Clinical trial NCT02324322: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Device: Robotic Exoskeleton
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: New Jersey Commission on Spinal Cord Research
First posted: 2014-12-24
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement.
timeFrame: 100 hours
Secondary outcomes:
measure: Muscle Activation
timeFrame: 100 hours
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Gail F Forrest, PhD
role: PRINCIPAL_INVESTIGATOR
References: