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El ensayo clínico NCT03096366 para Quadriceps Atrophy, Reconstrucción del LCA está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?
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El estudio clínico NCT03096366 es un ensayo intervencionista para Quadriceps Atrophy, Reconstrucción del LCA. Su estado actual es: reclutando. El ensayo se inició el 21 de noviembre de 2017, con el objetivo de reclutar a 150 participantes. Dirigido por The University of Texas Health Science Center, Houston, se espera que finalice el 1 de diciembre de 2022. Los datos se actualizaron por última vez en ClinicalTrials.gov el 4 de mayo de 2022.
Resumen
The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR training compared to PT alone (without BFR training) after ACL reconstruction in patients who require extended limited weight bearing through assessment of patient reported outcomes and functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of quadriceps muscle cross-sectional area, strength, and function while also improving early clinical and functional results.
Título oficial
Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery? A Randomized Clinical Trial
Condiciones médicas
Quadriceps AtrophyReconstrucción del LCAOtros ID del ensayo
- HSC-MS-16-1047
Número del NCT
Inicio del ensayo (real)
2017-11-21
Última actualización
2022-05-04
Fecha de finalización (estimada)
2022-12
Inscripción (prevista)
150
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
anterior cruciate ligament reconstruction
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalPhysical therapy (PT) plus blood flow restriction (BFR) Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. With BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg). | Restricción del flujo sanguíneo With BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg). Terapia Física Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. |
Comparador activoPhysical therapy Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. | Terapia Física Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 1 month after start of PT |
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 2 months after start of PT |
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 5 months after start of PT |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 1 month after start of PT |
Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 2 months after start of PT |
Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 5 months after start of PT |
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb. Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb.Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb.Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
Isometric quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 1 month after start of PT |
Isometric quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Isokinetic quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
Functional Performance as Assessed by Balance Error Scoring System | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Functional Performance as Assessed by Balance Error Scoring System | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Functional Performance as Assessed by Overhead Squat Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Functional Performance as Assessed by Overhead Squat Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Functional Performance as Assessed by Y-Balance Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Functional Performance as Assessed by Y-Balance Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Functional Performance as Assessed by Single-Leg Squat Assessment | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Functional Performance as Assessed by Single-Leg Squat Assessment | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Functional Performance as Assessed by Vail Sport Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Functional Performance as Assessed by Vail Sport Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Functional Performance as Assessed by Landing Error Scoring System | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Functional Performance as Assessed by Landing Error Scoring System | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Functional Performance as Assessed by Single leg Hop Testing | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
Functional Performance as Assessed by Single leg Hop Testing | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
Criterios de elegibilidad
Criterios de edad
Niño, Adulto
Edad mínima
14 Years
Criterios de sexo
Todos
- Anterior cruciate ligament (ACL) reconstruction with concomitant meniscus or cartilage restoration procedures
- Adherence to modified weight bearing status before initiation of PT
- Expected participation in recreational or competitive sports after release to full activities
- Unable to attend (or participate in) physical therapy
- Pregnancy
- Malignancy
- Fracture
- Peripheral vascular disease
- History of deep vein thrombosis (DVT)
The University of Texas Health Science Center, HoustonMemorial Hermann HospitalParte responsable del ensayo
Walter R Lowe, Investigador principal, Professor and Chair, The University of Texas Health Science Center, Houston
Contactos centrales del ensayo
Contacto: Walter R Lowe, MD, 713-486-6844, [email protected]
1 Sitios del ensayo en 1 países
Texas
The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States
Walter R Lowe, MD, Contacto, 713-486-6844, [email protected]
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