Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-01-01 @ 5:15 AM
Study NCT ID:
NCT02560506
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Low Cost Devices to Increase Access to Treadmill Training
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
Official Title:
Development of Low Cost Devices to Increase Access to Treadmill Training
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of this Model System Program are to expand upon and advance the findings and outcomes of previous and current Model Systems clinical research, to continue to develop and study the effectiveness of innovative treatment strategies for persons with spinal cord injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated, interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI. In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord Injury Care System (MRSCICS) model system grant proposal will be accomplished.
Detailed Description:
The investigators will develop and assess the use of spring-loaded devices to assist limb swing and forward propulsion during body weight supported treadmill training (BWSTT) (Aim 1). Prototype models of both devices have been developed.
These devices will be:
1. simple to use in the clinical setting;
2. will be easily adjustable to alter the assistance provided; and,
3. will be able to quantify the amount of assistance necessary to facilitate normal stepping patterns.
The investigators will also evaluate short- and long-term adaptations in locomotor performance following BWSTT in individuals with incomplete SCI with the use of these devices. This information will identify the effects of variable assistance at the limbs or trunk to modulate muscle activity and/or motor performance (kinematics) during stepping to maximize walking recovery.
These devices will be:
1. simple to use in the clinical setting;
2. will be easily adjustable to alter the assistance provided; and,
3. will be able to quantify the amount of assistance necessary to facilitate normal stepping patterns.
The investigators will also evaluate short- and long-term adaptations in locomotor performance following BWSTT in individuals with incomplete SCI with the use of these devices. This information will identify the effects of variable assistance at the limbs or trunk to modulate muscle activity and/or motor performance (kinematics) during stepping to maximize walking recovery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: