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Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation (BFR-TMR-ACL)

9 de mayo de 2026 actualizado por: Ali Muslim Raza, Green International University

Effects of Blood Flow Restriction With or Without Total Motion Release on Strength, Balance and Functional Disability in Postoperative ACL Injury

The aim of this clinical trial is to compare the effectiveness of combined Blood Flow Restriction (BFR) and Total Motion Release (TMR) versus BFR alone in the restoration of muscular strength, balance and knee functionality in men and women aged 16 to 45 years who have undergone primary unilateral ACL reconstruction.

The major research questions that it seeks to address are:

Does the addition of TMR to a BFR protocol lead to significantly higher improvements in absolute quadriceps strength and subjective knee functioning as measured by IKDC scores? Does the combined protocol lead to better functional balance and symmetry in terms of the Single Leg Stance (SLS) test and Limb Symmetry Index (LSI)? The researchers will compare the BFR + TMR group to the BFR-only group to determine whether the integrated approach speeds up functional recovery and alleviates neuromuscular control deficits more effectively than strength-focused training alone.

Participant TasksParticipants will: Undergo 3 sessions/week of supervised rehabilitation over a 6 month period. Complete Blood Flow Restriction (BFR) training consisting of low-load exercises (mini squats and knee extensions) with an inflatable cuff placed around the proximal part of the thigh at 60-80% occlusion pressure. Should there be in the experimental group, Total Motion Release (TMR) exercises (e.g., trunk rotations and hip shifts) on the contralateral side (i.e. non-painful side) to correct movement asymmetries before the BFR training. Baseline, 6 weeks, 12 weeks, and 6 months of complete subjective self-assessments (IKDC forms) and objective physical tests (dynamometer strength testing and single-leg balance tests).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Evaluate and compare the effectiveness of Blood Flow Restriction (BFR) therapy as a single intervention against a combined protocol of Blood Flow Restriction and Total Motion Release (BFR+TMR) in men and women aged 16-45 who had undergone primary unilateral ACL reconstruction. The study aimed to address persistent deficits in quadriceps strength, neuromuscular control, and movement symmetry that often remain after standard rehabilitation.

The main questions it aimed to answer were:

Did the integration of TMR-a method focused on movement symmetry-into a BFR protocol lead to superior improvements in absolute quadriceps strength and subjective knee function as measured by IKDC scores? Did the combined BFR+TMR protocol result in significantly better functional balance and limb symmetry compared to BFR training alone? Researchers compared a BFR+TMR experimental group to a BFR-only control group. The primary objective was to see if the combined approach, which targeted both peripheral muscle capacity (via BFR) and central neuromotor control (via TMR), provided a more holistic and accelerated recovery than targeting muscular adaptations alone.

Complete a 6-month rehabilitation program consisting of supervised sessions three times per week.

Perform Blood Flow Restriction (BFR) training on the affected limb using an inflatable cuff at 60-80% occlusion pressure during low-load resistance exercises such as mini squats and knee extensions.

If assigned to the experimental group, perform Total Motion Release (TMR) exercises (including trunk rotations, side bending, and hip shifts) on the non-painful, contralateral side prior to the strengthening exercises.

Undergo periodic assessments including isometric strength testing with a dynamometer, the Single Leg Stance (SLS) test for balance, and the completion of the IKDC Subjective Knee Form.

Maintain a record of progress across four specific time points: baseline, 6 weeks, 12 weeks, and 6 months.

Tipo de estudio

Intervencionista

Inscripción (Actual)

44

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Pakistán
    • Punjab Province
      • Lahore, Punjab Province, Pakistán, 54000
        • Green International University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Age 16-45 years.
  • Both male and female patients.
  • Underwent primary unilateral ACL reconstruction (hamstring or patellar tendon autograft).
  • 2-4 weeks post-operative and cleared for supervised rehabilitation.
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Revision ACL surgery or multi-ligament injury.
  • Concomitant fracture or meniscal repair requiring restricted rehab.
  • History of DVT, vascular disease, uncontrolled hypertension, or cardiovascular disease.
  • Neurological disorders affecting lower limb strength or balance.
  • Contraindications to BFR (pregnancy, clotting disorders).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: BFR + TMR Group
Describe the Blood Flow Restruction and the Total Motion Release exercises
Dispositivo: Blood Flow Restriction

Blood Flow Restriction (BFR): Use the exact same cuff and pressure settings as Group 1 so the comparison is fair.

The Exercises: List the specific movements (e.g., Straight Leg Raises, Quad sets, or Knee Extensions).

The Difference: State clearly: "This group receives standard BFR training and traditional physical therapy without any TMR protocols."

Procedimiento: Total Motion Release

Blood Flow Restriction (BFR): Specify the cuff type (e.g., automated or manual), the width of the cuff, and the pressure used (e.g., 80% of Limb Occlusion Pressure).

Total Motion Release (TMR): Explain that you are using the "TMR protocol." Mention that you treat the "good" side or the "non-painful" side to influence the injured side.

The Dose: How many minutes? How many times per week? (e.g., 30-minute sessions, 3 times per week for 12 weeks).

The Difference: State clearly: "This group receives the TMR balancing protocol in addition to standard BFR training."
Comparador activo: BFR Only Group
Describe only the blood flow restriction part.
Dispositivo: Blood Flow Restriction

Blood Flow Restriction (BFR): Use the exact same cuff and pressure settings as Group 1 so the comparison is fair.

The Exercises: List the specific movements (e.g., Straight Leg Raises, Quad sets, or Knee Extensions).

The Difference: State clearly: "This group receives standard BFR training and traditional physical therapy without any TMR protocols."

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximum Isometric Lower Limb Strength
Periodo de tiempo: Basaeline, 6 weeks, 12 weeks and 6 months.
Maximum isometric force of the affected limb measured using a hand-held dynamometer. This assesses the recovery from muscle atrophy and the return of power during the rehabilitation period.
Basaeline, 6 weeks, 12 weeks and 6 months.
Single Leg Stance (SLS) Test Time
Periodo de tiempo: Basaeline, 6 weeks, 12 weeks and 6 months.
The duration a participant can stand unassisted on the injured leg without moving or compensating. This test determines the regain of static balance and proprioception.
Basaeline, 6 weeks, 12 weeks and 6 months.
Total Score of International Knee Documentation Committee (IKDC) Subjective Knee Form
Periodo de tiempo: Baseline, 6 weeks, 12 weeks, and 6 months.
The IKDC Subjective Knee Form is a patient-reported outcome measure used to assess functional disability. It combines 18 items covering three domains: symptoms, physical activity, and knee function. All individual items are summed and transformed into a total score. A score of 100 indicates no limitation in activities of daily living or sports, while a score of 0 indicates maximum limitation. This measure provides a single aggregated value of the participant's self-reported functional status.
Baseline, 6 weeks, 12 weeks, and 6 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Green International University

Colaboradores

Sir Ganga Ram Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de noviembre de 2025

Finalización primaria (Actual)

21 de abril de 2026

Finalización del estudio (Actual)

5 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

5 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de mayo de 2026

Publicado por primera vez (Actual)

15 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GIU/REC/26-30 (Otro identificador: Research Ethical Committee, Green International University)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Only IDP used in the publication will be shared

Marco de tiempo para compartir IPD

It will be availabe after the completion of the study

Criterios de acceso compartido de IPD

Through the corresponding author

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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