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

Spinal Cord Injury Clinical Trial

— Indego  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02202538
• Other study ID #: PH-IND01
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2014
• Last updated: June 24, 2015
• Start date: August 2014

Study information

• Verified date: July 2014
• Source: Human Motion and Control
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Aquired) 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Indego
Indego

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia
United States	Rehabilitation Institue of Chicago	Chicago	Illinois
United States	Craig Hospital	Englewood	Colorado
United States	RUSK Rehabilitation Center	New York	New York
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Human Motion and Control	Parker Hannifin Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking with the Indego Device	To demonstrate that the average walking speed for persons with spinal cord injury using the Indego® device with stability aid will be equal to or greater than 0.31 m/s for indoor surfaces.; To demonstrate that the Indego® device is both safe and effective at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions; indoor surfaces, outdoor surfaces, elevators, managing doorways, different seat heights and extended distances.	8 weeks	Yes