ExoAtlet II For SCI Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2020-01-04

Brief Summary

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This study will evaluate the ExoAtlet II exoskeleton for safety and effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited ambulatory function, to stand up and ambulate under a variety of conditions.

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Detailed Description

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The study will introduce the ExoAtlet II exoskeleton to SCI patients with lower extremity paralysis (partial or complete) and provide rehabilitative standing and walking intervention. The study will be conducted with a trained clinician that will fit each patient into the adjustable exoskeleton system and provide customized programming to meet each user's specific needs. The training program will be initiated based upon each patient's comfort in the exoskeleton and ability to stand with assistance. Each patient will be closely monitored to assess ongoing health as well as their individual standing and walking ability. All exoskeleton sessions will be performed with a trained medical professional controlling the exoskeleton. Patient safety is the primary concern and all adverse events will be documented and addressed. This study will evaluate the ExoAtlet 2.0 exoskeleton for safety and effectiveness of providing persons with a spinal cord injury (SCI) who are non-ambulatory or have limited ambulatory function, the ability to stand up and walk in a clinical facility.

Conditions

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Spinal Cord Injuries Paraplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

SCI Level T4-L5 or, C7-T3 with ASIA D

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ExoAtlet II Safety and Efficacy

20 participants with paraplegia from SCI will participate in gait training using ExoAtlet II powered exoskeleton.

Group Type EXPERIMENTAL

Gait training using ExoAtlet exoskeleton

Intervention Type DEVICE

Subjects will learn to use the ExoAtlet II exoskeleton, with the assistance of a trained medical professional, to perform functional activities (including stand-up, sit-down, stepping forward, and walking).

Interventions

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Gait training using ExoAtlet exoskeleton

Subjects will learn to use the ExoAtlet II exoskeleton, with the assistance of a trained medical professional, to perform functional activities (including stand-up, sit-down, stepping forward, and walking).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 18 Years of age or older in general good health
2. Weight, no more than 220lbs (100kg)
3. Skin must be healthy where it touches the ExoAtlet 2.0
4. Able to stand using a device such as a standing frame
5. Have enough strength in your hands and shoulders to support yourself standing and walking using crutches or a walker
6. Have good control of upper body
7. Determined to have enough bone health to walk full weight bearing without risk of fracture. Meeting of this condition is at the discretion of your personal MD
8. Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid
9. Hip width no greater than 18" (46 cm) measured when sitting.
10. Femur length between 37 cm and 49 cm measured between mid patellar tendon and the floor.
11. In general, good health and able to tolerate moderate levels of activity.
12. Blood pressure and heart rate within established guidelines for locomotive training: At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 100 or less Exercise; Systolic 180 or less, Diastolic 105 or less and Heart Rate 145 or less

Exclusion Criteria

1. Spinal cord injury level higher than T4 or C7 ASIA D
2. Severe muscle stiffness/tightness
3. Significant spasticity (Modified Ashworth Scale score of 3 or above)
4. Trunk or lower extremity pressure ulcer
5. Open Wounds/tissue hypersensitivity
6. Unstable spine, un-healed limbs, or fractures
7. Severe sensitivity to touch
8. Presence of bone in soft tissue where bone normally does not exist (heterotopic ossification), limiting range of motion in the hip or knee joints
9. Joint instability, dislocation, moderate to severe hip dysplasia
10. Significant scoliosis (\>40 degrees)
11. Hardware, implant, or any external device impeding with safe fitting or use of ExoAtlet 2.0
12. Femoral or tibial rotation deformity (\>15 degrees)
13. Significant flexion contractures limited to 35º at the hip and 20º at the knee
14. Uncontrolled seizures, musculoskeletal injury, fracture or lower-limb surgery in past year.
15. Known history of pulmonary disease limiting exercise tolerance or history of cardiac disease
16. Psychopathology, or other condition that the physician or investigator, in his or her clinical judgment, considers to be exclusionary to safely use an exoskeleton.
17. Severe concurrent medical diseases, illness, systemic or peripheral infection
18. Dizziness or headache with standing
19. History of autonomic dysreflexia
20. Orthostatic Hypotension: Decrease in Systolic BP \> 20, Diastolic BP \> 10 upon standing from a seated position.
21. Pregnant or lactating females

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No