- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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 julho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
46
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Dr Shoaib Waqas, Phd
- Número de telefone: +92 302 4552109
- E-mail: shoaib.waqas@ubas.edu.pk
Locais de estudo
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Punjab Province
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Lahore, Punjab Province, Paquistão, 54000
- Recrutamento
- Shareef Medical City Hospital
-
Contato:
- Baseerat Iqbal, DPT, MSPT
- Número de telefone: +923334705441
- E-mail: ibaseerat@yahoo.com
-
Investigador principal:
- Nargiza Saleem, Dpt
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quadriceps Muscle Strength
Prazo: 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
|
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Pain Intensity
Prazo: 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).
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Baseline and 8 weeks post-intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Dr Shaoib Waqas, Phd, Lahore University of Biological and Applied Sciences
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
28 de julho de 2026
Conclusão Primária (Estimado)
1 de outubro de 2026
Conclusão do estudo (Estimado)
25 de novembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
17 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de junho de 2026
Primeira postagem (Real)
23 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de julho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Transtornos Mentais, Desordem Mental
- Transtornos Fóbicos
- Transtornos de ansiedade
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Cinesiofobia
- Dor
- Terapêutica
- Modalidades de fisioterapia
- Atendimento ao paciente
- Terapia de exercícios
- Reabilitação
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Terapia de restrição de fluxo sanguíneo
Outros números de identificação do estudo
- UBAS/ERB/26/04/026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Baseline participants
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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