West Orange, New Jersey 07052


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT02324322


Primary Contact:

Principal Investigator
Gail F Forrest, PhD
Kessler Foundation

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


Backup Contact:

N/A


Location Contact:

West Orange, New Jersey 07052
United States

Gail F Forrest, Ph.D
Phone: 973-324-3518
Email: gforrest@kesslerfoundation.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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