Indego Exoskeleton After SCI
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|ClinicalTrials.gov Identifier: NCT02793635|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : August 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: Indego Powered Exoskeleton||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Gait Training With an Exoskeleton on Walking Function After Spinal Cord Injury (SCI)|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Experimental: SCI Patients
Device: 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.
Other Name: Vanderbilt exoskeleton
- Functional ambulation category (FAC) to measure gait quality [ Time Frame: 1 Day ]Categorizes patients according to basic motor skills necessary for functional ambulation
- 10 Meter Walking Test to measure fast gait speed [ Time Frame: 1 Day ]Assesses walking speed in meters per second over a short duration
- 6 Minute Walking test to measure endurance [ Time Frame: 6 Minutes ]Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793635
|United States, New York|
|St. Charles Hospital|
|Port Jefferson, New York, United States|
|United States, Texas|
|TIRR Memorial Hermann|
|Houston, Texas, United States, - TIRR Memorial Hermann,|
|United States, Virginia|
|Mechanicsville, Virginia, United States, 23116|