Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).

NCT ID: NCT02202538

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-10-31

Brief Summary

This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Indego

Indego

Group Type: EXPERIMENTAL

Indego

Intervention Type: DEVICE

Indego

Interventions

Indego

Indego

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Be 18 years or older
• Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length).
• Hip width as measured in sitting no greater than 16.6" (42 cm) (acceptable hip width may vary depending on soft tissue).
• Femur length as measured in sitting must be between 14 inches (35.5cm) and 18.5 inches (47 cm)
• Weight 250lbs (113.4 kg) or less
• Present with Spinal Cord Injury and NLI C5 and lower, with ISNCSCI A, B, C or D who are non-ambulatory or poorly ambulatory.
• There are no restrictions on time since injury. However, each subject must have signed medical clearance/approval for full weight bearing and locomotor training.
• Determined to have sufficient bone health for walking with full weight bearing without undue risk for fracture. Meeting of this criterion is at the discretion of each subject's personal MD and must be approved by each site's Medical PI.
• 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.
• Skin must be intact where it interfaces with robotic device
• Modified Ashworth Scale for spasticity score must be 3 or less.
• Blood pressure and heart rate within established guidelines for locomotor training:

• At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less
• Exercise; Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less
• Tolerate being in an upright standing position (passive or active) without being lightheaded or having a headache.

Exclusion Criteria

• Weight in excess of 250 lbs
• Heterotopic ossification that, in the opinion of the investigator, would place the subject at undue risk for fracture.
• Any subject deemed at increased risk for injury by Medical Personnel
• Lower extremity joint limitation that exceeds 10 degrees at their hips, knees or ankles.
• Light headedness or headache in standing position (active or passive)
• Moderate to Severe Traumatic (or Acquired) Brain Injury
• Inability to follow instructions
• Colostomy bag
• Women who are pregnant or attempting to become pregnant during the study intervention.
• Unable to obtain informed consent (either from the subject or from the subjects Legally Authorized Representative).
• Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
• Unlikely to be available for follow-up phone call.
• Any other issue which, in the opinion of the investigators, will make the subject unsuitable for study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parker Hannifin Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Craig Hospital

Englewood, Colorado, United States

Shepherd Center

Atlanta, Georgia, United States

Rehabilitation Institue of Chicago

Chicago, Illinois, United States

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

RUSK Rehabilitation Center

New York, New York, United States

Countries

United States

Other Identifiers

PH-IND01

Identifier Type: -

Identifier Source: org_study_id