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Spinal Cord Injuries or Similar Neurological Weakness | EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI)

Spinal Cord Injuries or Similar Neurological Weakness research study

What is the primary objective of this study?

This study seeks to test the safety and efficacy of the Esko device in SCI population and in populations with similar neurological weakness to the SCI population. The device can currently stand from a seated position, walk, and turn and sit down. Our hypothesis are as follows: - Hypothesis 1: We hypothesize that the Ekso subject will significantly improve balance while wearing the device as noted by subject's ability to safely achieve standing balance for 30 sec without loss of balance. - Hypothesis 2: We hypothesize that the Ekso subject will display improved ability to safely ambulate 10 meters to be assessed using the 10 meter walk test. - Hypothesis 3: We hypothesize that the Ekso subject will display improved weight shift in both static and dynamic activities as determined by a trained physical therapist. - Hypothesis 4: We hypothesize that the Ekso subject will verbalize improved success with training of the device as noted by subjective questionnaires that will be assessed following each training session.

Who is eligible to participate?

Inclusion Criteria: Participants must: - have a spinal cord injury SCI between C7-S1. - be between 18-65 years of age. - be able to physically fit into the exoskeletal device. - be able to tolerate upright standing for a minimum of 30 minutes. - have joint range of motion (ROM) within normal functional limits for ambulation. - have sufficient upper body strength to balance themselves using the walker while wearing the exoskeleton. - have a different neurological weakness than SCI but fit the other inclusion criteria above Exclusion Criteria: - Height below 62 inches or above 74 inches - Weight above 220 lbs. - Joint contractures of any extremity that limits normal ROM during ambulation with assistive devices. - Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity) - Skin issues that would prevent wearing the device. - Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions well and demonstrate learning capability. - Significant Osteoporosis: Osteoporosis will be graded based on the T score that indicates a person's bone mineral content and is graded as follows: (14) T +1: Normal bone density: - T -1 to -2.5: Low bone density of osteopenia - T -2.5 to -3.0: osteoporosis - T <-3.0: Severe osteoporosis - If the patient has severe osteoporosis and a T score of <-3, participation in the study will be considered based upon their physicians recommendation and overall evaluation of the patient.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Spinal Cord Injuries or Similar Neurological Weakness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Ekso exoskeletonThe participants will receive 1 - 40 training sessions. The sessions will be 1 hour of device use including balance training, gait training and sit to and from stand training with rolling walker and/ or forearm crutches.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ekso Safety and EfficacyObservational study on the first time use of a robotic exoskeleton.

Study Status

Active, not recruiting

Start Date: May 2012

Completed Date: September 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in 6 Minute Walk Test from baseline in distance, rate of perceived exhaustion (RPE), and oxygen uptake

Secondary Outcome: Ratio of number of steps/walking time

Study sponsors, principal investigator, and references

Principal Investigator: Arun Jayaraman, PhD

Lead Sponsor: Shirley Ryan AbilityLab

Collaborator: United States Department of Defense

More information:https://clinicaltrials.gov/show/NCT01701388

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