Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle
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|ClinicalTrials.gov Identifier: NCT02324322|
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : March 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: Exoskeleton Training Other: Muscle Biopsies Other: MRI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Ambulatory SCI Walk Using a Robotic Exoskeleton: Effect on Bone and Muscle|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: Exoskeleton training
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
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 Name: Ekso
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 Name: Needle Biopsies
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.
- Bilateral Muscle Volume (surrogate for strength)for thigh and shank will be the primary outcome measurement. [ Time Frame: 100 hours ]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.
- Muscle Activation [ Time Frame: 100 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324322
|Contact: Gail F Forrest, PhD||973-324-3518 ext firstname.lastname@example.org|
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Contact: Gail F Forrest, Ph.D 973-324-3518 email@example.com|
|Principal Investigator:||Gail F Forrest, PhD||Kessler Foundation|