Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-07
Brief Title:
Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Knee Arthropathy
Sponsor:
Investigación en Hemofilia y Fisioterapia
Organization:
Investigación en Hemofilia y Fisioterapia
Study Overview
Official Title:
Safety and Efficacy of a Physiotherapy Intervention Through Blood Flow Restriction in Improving Muscle Strength in Patients With Hemophilic Knee Arthropathy Multicenter Randomized Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
Background The main physical sequela of patients with hemophilia is the development of a progressive degenerative intra-articular lesion known as hemophilic arthropathy This sequela is manifested by chronic pain limited range of motion axial abnormalities and periarticular muscle atrophy
Objective To assess the safety and effectiveness of an intervention through blood flow restriction regarding the frequency of bleeding and the improvement in muscle activation and strength range of motion functionality joint pain joint status and the perception of quality of life in patients with hemophilic arthropathy knee and ankle
Study design Randomized multicenter single-blind clinical study Method 60 patients with hemophilia A and B will be recruited in this study Patients will be recruited in 6 regions of Spain The dependent variables will be bleeding frequency self-registration pain measured with the visual analog scale and pressure algometer quality of life SF-36 scale joint status Hemophilia Joint Health Score scale strength dynamometer and muscle activation surface electromyograph range of motion goniometer and functionality Timed up and go test Three evaluations will be carried out pre-treatment post-treatment and after a follow-up period of 4 weeks
Expected results Observe the safety of blood flow restriction in hemophilia patients To analyze the efficacy of blood flow restriction in improving muscle strength and activation range of motion chronic pain functionality and the perception of quality of life in patients with hemophilic knee and ankle arthropathy
Objective To assess the safety and effectiveness of an intervention through blood flow restriction regarding the frequency of bleeding and the improvement in muscle activation and strength range of motion functionality joint pain joint status and the perception of quality of life in patients with hemophilic arthropathy knee and ankle
Study design Randomized multicenter single-blind clinical study Method 60 patients with hemophilia A and B will be recruited in this study Patients will be recruited in 6 regions of Spain The dependent variables will be bleeding frequency self-registration pain measured with the visual analog scale and pressure algometer quality of life SF-36 scale joint status Hemophilia Joint Health Score scale strength dynamometer and muscle activation surface electromyograph range of motion goniometer and functionality Timed up and go test Three evaluations will be carried out pre-treatment post-treatment and after a follow-up period of 4 weeks
Expected results Observe the safety of blood flow restriction in hemophilia patients To analyze the efficacy of blood flow restriction in improving muscle strength and activation range of motion chronic pain functionality and the perception of quality of life in patients with hemophilic knee and ankle arthropathy
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None