Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781621
Status:
UNKNOWN
Last Update Posted:
2021-07-02
First Post:
2021-02-03
Brief Title:
Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
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:
FIRST
Brief Summary:
The FIRST project compares the dose of robotic gait training RGT with usual care gait training for patients with spinal cord injury SCI undergoing rehabilitation at Baylor Scott White Institute for Rehabilitation BSWIR
Detailed Description:
Spinal cord injury SCI due to trauma is estimated to affect 288000 - 500000 Americans with about 17700 new cases annually Recovery of walking is a primary rehabilitation goal for patients and encouraged by therapists due to its relationship to quality of life impact on health psychological profile and social participation after SCI Recent technological advances with exoskeleton devices specifically for gait training may yield better walking recovery outcomes compared with usual care intervention approaches such as body-weight support treadmill training BWSTT and overground gait training with braces yet limited evidence exists for those with SCI
Aim 1 Use a Community-Based Participatory Research approach to develop an robotic gait training RGT program that meets the unique needs of people after incomplete SCI during inpatient rehabilitation This will be achieved by establishing and engaging an Advisory Board of key stakeholders to review evidence-based literature advise the research team on the unique aspects and goals of inpatient rehabilitation for people with SCI review the RGT and make recommendations for amendments to the RGT program based on our interim and final outcomes of the study over the funding period
Aim 2 Prospectively examine the efficacy of RGT compared to usual care gait training during inpatient rehabilitation in people with incomplete SCI
Aim 3 Compare the intensity of RGT and usual care gait training during inpatient rehabilitation
Aim 1 Use a Community-Based Participatory Research approach to develop an robotic gait training RGT program that meets the unique needs of people after incomplete SCI during inpatient rehabilitation This will be achieved by establishing and engaging an Advisory Board of key stakeholders to review evidence-based literature advise the research team on the unique aspects and goals of inpatient rehabilitation for people with SCI review the RGT and make recommendations for amendments to the RGT program based on our interim and final outcomes of the study over the funding period
Aim 2 Prospectively examine the efficacy of RGT compared to usual care gait training during inpatient rehabilitation in people with incomplete SCI
Aim 3 Compare the intensity of RGT and usual care gait training during inpatient rehabilitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None