NCT02324322

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-12-01
• Completion: 2018-03-01
• First posted: 2014-12-24
• Last updated: 2017-03-22

Locations

1 site across 1 country: United States