Seated Balance Using the Indego™
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|ClinicalTrials.gov Identifier: NCT04047992|
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Indego™ Exoskeleton||Not Applicable|
Introduction/Background: People with spinal cord injury (SCI) can lose partial to complete voluntary control of arm, trunk and leg muscles, resulting in an inability to sit with stability, stand and/or walk. Because of poor trunk control during sitting, it may be challenging to reach for objects, dress or transfer independently, and the risk of a fall from their wheelchair is increased. Exoskeleton-assisted walking (EAW) provides upright, over ground mobility and has been demonstrated to be beneficial to improve patient-reported quality of life and some health-related outcomes. However, present day exoskeletons are not ready to replace the wheelchair. Our preliminary findings suggest that while walking in an exoskeleton, people with SCI are challenged to maintain upright balance by using their trunk muscles in a way that is rarely done from a wheelchair. Stimulation of the trunk muscles from upright postural challenges during EAW appears to benefit overall seated trunk control.
Summary of Goals and Objectives: The purpose of this study is to determine whether EAW can improve the primary outcomes of: seated balance, seated activities of daily living, and trunk muscle use. Additional secondary outcomes for body composition will be studied. Twenty people with SCI (T4 and below) who are wheelchair users will be recruited to participate.
Impact: The investigators believe that EAW training will significantly improve seated balance to improve wheelchair safety, stability and quality of life, thus, empowering people with SCI who use a wheelchair to live more independently. If EAW is demonstrated to have a significant benefit on seated balance, then use of these devices in the clinical and home environments may be further justified.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||"The Effects of Exoskeletal-Assisted Walking on Seated Balance Using the Indego™"|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Exoskeleton Users
All participants will receive 36 sessions of supervised EAW training using Indego™ for 12 weeks (3 to 4 sessions per week, 4-6 hours per week). The goal is to complete all 36 sessions in 12 weeks, but allowing for a two-week carryover to accommodate schedule conflicts or missed sessions.
Device: Indego™ Exoskeleton
The Indego® is a powered exoskeleton that can be used as a mode of therapy in an institutional setting. Proper walking in this device requires the user to manipulate their center of gravity and balance by postural trunk excursions in order for the legs to take steps.
- Seated Computerized Dynamic Posturography (sCDP) [ Time Frame: Change from baseline after 8 weeks and after 12 weeks. ]Seated balance will be measured by assessment of the limits of stability (LOS) using computerized dynamic posturography (SMART EquiTest, Natus). The SMART EquiTest® system utilizes a dynamic force plate to quantify the vertical forces exerted through the participant's center of gravity as s/he sits on a cushioned block with back unsupported and arms crossed over the clavicles.
- Seated Activities of Daily Living (ADLs) [ Time Frame: Change from baseline after 8 weeks and after 12 weeks. ]Participants' seated ADLs will be assessed by self-reported Spinal Cord Independence Measure (SCIM) and Spinal Cord Injury - Functional Index (SCI-FI, short forms). Participants' functional performance of ADLs will be assessed using the timed t-shirt dressing test by a study team member.
- Motor Evoked Potentials (MEPs) [ Time Frame: Change from baseline after 8 weeks and after 12 weeks. ]Leg muscles will be used to assess neuroplastic changes between the motor cortex and descending neural pathways below incomplete spinal lesions.
- Spinal Cord Independence Measure (SCIM) [ Time Frame: Change from baseline after 8 weeks and after 12 weeks. ]The SCIM is a clinical tool to evaluate the independent performance of ADL especially for people with SCI.
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): NCT04047992
|United States, New York|
|James J. Peters VA Medical Center||Recruiting|
|Bronx, New York, United States, 10468|
|Contact: Steven Knezevic, MS 718-584-9000 ext 3130 Steven.Knezevic@va.gov|
|Contact: Pierre K Asselin, MS 718-584-9000 ext 3124 Pierre.Asselin@va.gov|
|Principal Investigator: Annn M Spungen, EdD|