Indego Exoskeleton After SCI

NCT ID: NCT02793635

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-03-31

Brief Summary

The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have preserved lower extremity function. It is hypothesized that subjects with complete or incomplete paraplegia who have preserved their lower extremity function will experience functional improvements after gait training with the Indego exoskeleton.

Subjects will complete a total of fifteen (15) sessions which include a combination of the following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and Post-Assessment.

The aim of this study is to measure the impact of gait training with the Indego device on body structure, function, and participation. Additionally it will assess the perceptions of physical therapists and subjects with SCI on the effectiveness of gait training with the Indego exoskeleton in subjects with preserved limited function.

Conditions

Spinal Cord Injury

Study Design

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

Study Groups

SCI Patients

• 10 subjects with complete or incomplete SCI (> 1 year post-injury) with preserved LE function will be recruited.
• No control group

Group Type: EXPERIMENTAL

Indego Powered Exoskeleton

Intervention Type: DEVICE

Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.

Interventions

Indego Powered Exoskeleton

Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.

Intervention Type: DEVICE

Other Intervention Names

Vanderbilt exoskeleton

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length)
• Weight 250 lbs or less
• Present with paraplegia resulting from a complete or incomplete (AIS A, B, C, or D) Spinal Cord Injury (>1 year post-injury), with preserved LE function
• Uses wheelchair as primary means of mobility in the community
• Able to ambulate 14 meters with assist of 2 people and no orthostasis. Subjects may use any combination of stability aids and/or bracing.
• Medical clearance for weight bearing and locomotor training

• Bone density exams will be at the discretion of each sites' Principle Investigator
• Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait and use of appropriate assistive device/stability aid
• Skin intact where interfaces with the Indego device
• Modified Ashworth Scale 3 or less in bilateral LEs
• Blood pressure and heart rate within Locomotor Training Guidelines

• 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

• Currently participating in physical therapy for gait training
• Joint contractures of the shoulders, trunk, hips knees or ankles deemed unsafe for locomotor training by PT and or MD
• Edema that would put skin at risk for breakdown
• Modified Ashworth Spasticity of 4
• Inability to achieve adequate fit of the Indego device
• Pregnancy
• Colostomy bag

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

Sponsors

Parker Hannifin Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Charles Hospital

Port Jefferson, New York, United States

TIRR Memorial Hermann

Houston, Texas, United States

Sheltering Arms

Mechanicsville, Virginia, United States

Countries

United States

Other Identifiers

15-01399

Identifier Type: -

Identifier Source: org_study_id