Clinical trial NCT02793635: Indego Exoskeleton After SCI
Official title: Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Paraplegia
Gait
Exoskeleton
Lead sponsor: Parker Hannifin Corporation
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Exclusion Criteria:

* Inability to meet ALL inclusion criteria
* 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

Primary outcomes:
measure: Functional ambulation category (FAC) to measure gait quality
timeFrame: 1 Day
measure: 10 Meter Walking Test to measure fast gait speed
timeFrame: 1 Day
measure: 6 Minute Walking test to measure endurance
timeFrame: 6 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Port Jefferson
country: United States
facility: St. Charles Hospital
state: New York
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
city: Mechanicsville
country: United States
facility: Sheltering Arms
state: Virginia
Study officials:
References: