Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT06254794
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2023-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of BFR Rehab After Achilles Tendon Rupture
Sponsor:
The Methodist Hospital Research Institute
Organization:
Study Overview
Official Title:
Effect of Blood Flow Restriction (BFR) Rehabilitation After Achilles Tendon Rupture Reconstruction
Status:
RECRUITING
Status Verified Date:
2025-05
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:
The purpose of this study is to determine if blood flow restriction therapy after Achilles tendon rupture reconstruction decreases post-operative calf atrophy, improves reported outcomes, and ultimately decreases return to play time.
Detailed Description:
The purpose of this research study is to determine if the use of Blood Flow Restriction, BFR, therapy in addition to standard physical therapy (PT) for post-Achilles tendon rupture reconstruction will decrease post-operative muscle atrophy (loss of muscle), increases dorsal and planar ankle flexion (range of motion), increase strength, and ultimately decrease return to play time for the BFR therapy group as compared to the control group.
Participants in this study will be randomly divided into either BFR group that will receive BFR therapy in addition to standard physical therapy protocol post-operatively or the control group which will undergo the standard PT protocol. All participants will complete full body composition scans (DEXA) and questionnaires before surgery, prior to physical therapy (three weeks post-op), eight weeks post-op, and 16 weeks post-op. Subjective and objective measures will be taken at physical therapy eight weeks and 16 weeks post-operatively.
Participants in this study will be randomly divided into either BFR group that will receive BFR therapy in addition to standard physical therapy protocol post-operatively or the control group which will undergo the standard PT protocol. All participants will complete full body composition scans (DEXA) and questionnaires before surgery, prior to physical therapy (three weeks post-op), eight weeks post-op, and 16 weeks post-op. Subjective and objective measures will be taken at physical therapy eight weeks and 16 weeks post-operatively.
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?: