- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07662850
Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.
21 de julio de 2026 actualizado por: Prof. Dr. Shoaib Waqas, Lahore University of Biological and Applied Sciences
This randomized clinical trial aims to compare the effects of Blood Flow Restriction Training (BFR) and Instrument-Assisted Soft Tissue Mobilization (IASTM) on pain, quadriceps muscle strength, knee range of motion (ROM), and kinesiophobia in patients following anterior cruciate ligament reconstruction (ACLR).
ACLR patients commonly experience persistent muscle weakness, limited ROM, pain, and fear of movement, which can delay functional recovery and return to activity.
A total of 46 participants (8-16 weeks post-ACLR) will be randomly allocated into two groups: a BFR group and an IASTM group.
Both groups will receive interventions twice weekly for 8 weeks alongside standard physiotherapy.
The BFR group will perform low-load resistance exercises under controlled vascular occlusion, while the IASTM group will receive soft tissue mobilization using specialized instruments combined with conventional rehabilitation.
Outcome measures will include quadriceps strength (handheld dynamometer), pain (Numeric Pain Rating Scale), knee ROM (goniometer), and kinesiophobia (Tampa Scale of Kinesiophobia), assessed at baseline and post-intervention.
The study aims to determine which intervention provides superior improvements in physical and psychological outcomes during early rehabilitation after ACL reconstruction.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Anterior cruciate ligament reconstruction (ACLR) is a commonly performed surgical procedure to restore knee stability following ACL injury.
Despite surgical success, many patients experience persistent quadriceps weakness, pain, reduced range of motion (ROM), and psychological barriers such as kinesiophobia, which can delay functional recovery and return to activity.
Optimizing early rehabilitation strategies is therefore essential to improve both physical and psychological outcomes after ACLR.
Blood Flow Restriction Training (BFR) and Instrument-Assisted Soft Tissue Mobilization (IASTM) are two emerging rehabilitation techniques increasingly used in musculoskeletal and postoperative care.
BFR involves the application of controlled external pressure to partially restrict blood flow during low-load resistance exercise, thereby promoting muscle strength and hypertrophy with minimal mechanical stress.
This makes it particularly suitable during early rehabilitation phases when high-load exercises may be contraindicated.
IASTM is a manual therapy technique that utilizes specialized instruments to mobilize soft tissues, improve circulation, reduce pain, and enhance tissue extensibility.
It is commonly used to address soft tissue restrictions, improve joint mobility, and support functional recovery.
Although both interventions have demonstrated beneficial effects independently, there is limited comparative evidence evaluating their relative effectiveness in patients undergoing ACLR.
Additionally, most previous studies have focused primarily on physical outcomes such as strength and ROM, with limited attention to psychological factors such as kinesiophobia, which play a critical role in rehabilitation success and return-to-sport readiness.
This study is designed as a two-arm parallel-group randomized clinical trial to compare the effects of BFR and IASTM on pain, quadriceps strength, knee ROM, and kinesiophobia in patients following ACLR.
A total of 46 participants, 8-16 weeks post-surgery, will be recruited and randomly allocated into either the BFR group or the IASTM group using a computer-generated randomization method with allocation concealment.
Participants in both groups will receive interventions twice weekly for 8 weeks, in addition to standard postoperative physiotherapy.
The BFR group will perform low-load quadriceps strengthening exercises under individualized occlusion pressure, while the IASTM group will receive structured soft tissue mobilization using specialized tools along with conventional rehabilitation exercises.
Outcome measures will include quadriceps muscle strength assessed using a handheld dynamometer, pain intensity measured with the Numeric Pain Rating Scale (NPRS), knee ROM assessed using a goniometer, and kinesiophobia evaluated using the Tampa Scale of Kinesiophobia (TSK-17).
Assessments will be conducted at baseline and after completion of the intervention period by blinded outcome assessors.
The findings of this study will provide comparative evidence regarding the effectiveness of BFR and IASTM in improving both physical and psychological outcomes during early rehabilitation after ACLR.
This may assist clinicians in selecting the most appropriate adjunctive treatment to optimize recovery and enhance return-to-function in this patient population.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
46
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.
Estudio Contacto
- Nombre: Dr Shoaib Waqas, Phd
- Número de teléfono: +92 302 4552109
- Correo electrónico: shoaib.waqas@ubas.edu.pk
Ubicaciones de estudio
-
-
Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Reclutamiento
- Shareef Medical City Hospital
-
Contacto:
- Baseerat Iqbal, DPT, MSPT
- Número de teléfono: +923334705441
- Correo electrónico: ibaseerat@yahoo.com
-
Investigador principal:
- Nargiza Saleem, Dpt
-
-
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
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age between 18 and 40 years.
- Both genders.
- Undergoing Primary Unilateral ACLR (using autologous tendon graft).
- Medically cleared for low load rehabilitation (Wound healed, stable graft per surgeon).
- Active knee flexion of ≥100° on the operative limb.
- 8-16 weeks after reconstructive surgery.
- Willing to comply with all rehabilitation sessions and follow up assessments; give informed consent
Exclusion Criteria:
- Significant meniscectomy requiring protected weight-bearing
- Active DVT, vascular disease, uncontrolled hypertension or other BFR contraindications
- Patients exhibiting extension lag (inability to achieve full active knee extension) on the operated limb.
- Neuromuscular disorders
- Skin lesions preventing IASTM
- Pregnancy
- Contraindications to exercise
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group A: Blood Flow Restriction Training
Participants in this group will be allocated to the Blood Flow Restriction Training group as part of a randomized parallel study design.
This group represents one of the two comparative rehabilitation arms in post-ACLR patients.
Allocation to this arm is based on computer-generated randomization with concealed assignment.
Participants in this arm will be evaluated for physical and psychological outcomes as part of the study protocol.
The group will be followed for the full study duration alongside the comparison arm.
|
Participants will receive Blood Flow Restriction Training as an adjunct to standard postoperative physiotherapy following ACL reconstruction.
A pneumatic cuff will be applied to the proximal thigh at individualized occlusion pressure to allow low-load exercise under restricted blood flow conditions.
The exercise program will include straight leg raises, quadriceps sets, and seated/short-arc knee extensions.
Training will focus on low-load quadriceps strengthening to promote muscle activation and recovery.
The intervention will be performed twice weekly for 8 weeks under physiotherapist supervision.
Safety, pain response, and limb tolerance will be continuously monitored during all sessions.
|
|
Comparador activo: Group B : Instrument Assisted Soft Tissue Mobilization
Participants in this group will be assigned to the Instrument-Assisted Soft Tissue Mobilization (IASTM) arm as part of a randomized parallel-group study design.
This arm represents the comparative rehabilitation approach for post-ACLR patients.
Allocation is performed using computer-generated randomization with concealed assignment.
Participants will be assessed for pain, strength, range of motion, and kinesiophobia as part of the study outcomes.
The group will follow the study protocol for the full intervention period alongside the comparison arm.
Outcome assessments will be conducted at baseline and post-intervention.
|
Participants will receive Instrument-Assisted Soft Tissue Mobilization as an adjunct to standard postoperative physiotherapy following ACL reconstruction.
Specialized stainless-steel instruments will be used to apply controlled mechanical pressure to soft tissues around the knee region.
Treatment will target peri-patellar structures, quadriceps, hamstrings, and surrounding thigh musculature.
The intervention aims to improve tissue mobility, reduce pain, and enhance range of motion.
Sessions will be conducted twice weekly for 8 weeks under trained physiotherapist supervision.
Each session will be standardized with continuous monitoring of pain response and treatment tolerance.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quadriceps Muscle Strength
Periodo de tiempo: Baseline and 8 weeks post-intervention
|
Quadriceps strength will be assessed using a handheld dynamometer to measure maximal isometric knee extensor force in a standardized seated position.
The highest value from repeated trials will be recorded for analysis.
|
Baseline and 8 weeks post-intervention
|
|
Pain Intensity
Periodo de tiempo: Baseline and 8 weeks post-intervention
|
Pain will be assessed using the Numeric Pain Rating Scale (NPRS), where participants rate their knee pain on an 11-point scale from 0 (no pain) to 10 (worst possible pain).
|
Baseline and 8 weeks post-intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Dr Shaoib Waqas, Phd, Lahore University of Biological and Applied Sciences
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 (Estimado)
28 de julio de 2026
Finalización primaria (Estimado)
1 de octubre de 2026
Finalización del estudio (Estimado)
25 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Desordenes mentales
- Trastornos fóbicos
- Desórdenes de ansiedad
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Kinesiofobia
- Dolor
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia de restricción de flujo sanguíneo
Otros números de identificación del estudio
- UBAS/ERB/26/04/026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Baseline participants
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. .