Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Blood Flow Restriction Training in Patients With Lower Extremity Fractures
Sponsor:
Denver Health and Hospital Authority
Organization:
Denver Health and Hospital Authority
Study Overview
Official Title:
Blood Flow Restriction Training Versus Traditional Rehab in Patients With Lower Extremity Fractures Effect on Fracture Healing Muscle Strength and Girth and Return to Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
This study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures compared to patients performing exercise without the device The study will compare muscle strength muscle size fracture healing and return to normal function between the two groups
Detailed Description:
This study will examine the effect of blood flow restriction BFR training in patients with lower extremity fractures Patients with tibial shaft fractures will be assigned to either the BFR group or control group The BFR group will perform exercises with a blood flow restriction device which occludes venous blood flow in the limb while performing strengthening exercises as directed by a Doctor of Physical Therapy The control group will perform the exercises without the device as is current standard practice in physical therapy Blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury and studies suggest that it increases biomarkers of bone metabolism and tissue healing The goal of this study is to examine the use of BFR in trauma patients using a defined protocol and compare fracture healing muscle strength muscle girth and subjective physical function between groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None