Identification of New Biomarkers for Determining Risk of Lower Extremity Fracture during Exoskeleton-assisted Ambulation

The purpose of this study is to determine the forces on the hips, knees, and ankle joints while participating in exoskeleton-assisted sit-to-stand training protocol as well as exoskeleton-assisted walking (EAW) in the ReWalk, Indego, and Ekso devices.

 

For more information about this study, please contact Christopher Cirnigliaro at [email protected].

Actively Recruiting
Yes
Duration

The study consists of three specific aims that each participant may randomly be selected for if s/he meet the inclusion/exclusion criteria. Specific Aim 1 consists of 2 study visits. Specific Aim 2 consists of up to 10 study visits. Specific Aim 3 consists of up to 40 study visits.

Inclusion Criteria

Specific Aim 1, 2, and 3:

  1. I am between 18 and 70 years of age.
  2. I have a motor-complete or motor-incomplete SCI with a grade of A, B, or C according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), [ formerly American Spinal Injury Association (ASIA) Impairment Scale].
  3. I am wheelchair dependent 100% of the time OR I am a healthy able-bodied male or female.

Specific Aim 2 (EAW Sit-to-Stand) and Aim 3 (EAW Walking) Only:

  1. The study staff has determined that I can fit into the walking device based on my weight and height.
  2. My weight is less than 220 lb.
  3. My height is between 62-75 in (5ft 2in – 6ft 3in)
  4. The study staff has determined that the T-score acquired by a bone density test (DXA)scan is greater than or equal to -3.1 OR my bone mineral density above the knee acquired by bone density test (DXA) is greater than or equal to 0.6 g/cm2
  5. I have adequate lower leg joint range of motion as determined by the study staff.
  6. I have a SCI and can commit for up to 10 sit-to-stand training sessions and up to 40 EAW training sessions OR I am an able-bodied control participant and can commit up to 3 sit-to-stand training sessions and up to 10 EAW training sessions.
  7. I can commit to 1 sit-to-stand motion analysis session and 3 EAW Sit-to-Stand walking motion analysis sessions.
Compensation

Imaging Visit 1 (DXA, Peripheral quantitative computed tomography [pQCT]): $50

Imaging Visit 2 (computerized tomography (CT) scan): $50

Exoskeletal Sit-to-Stand Motion Capture Session: $100

EAW Motion Capture Session 1: $100

EAW Motion Capture Session 2: $100

EAW Motion Capture Session 3: $100

IRB Number:

R-1162-21

Research Center
Center for Spinal Cord Injury Research
Research Coordinator