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临床试验/NCT07662850
NCT07662850招募中不适用

Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
46
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Group A: Blood Flow Restriction Training

Experimental

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.

干预措施: Blood Flow Restriction Training (Other)

Group B : Instrument Assisted Soft Tissue Mobilization

Active Comparator

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.

干预措施: Instrument-Assisted Soft Tissue Mobilization (IASTM) (Other)

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Shoaib Waqas

Professor

Lahore University of Biological and Applied Sciences

研究点 (1)

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