Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.
2026年7月21日 更新者: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.
研究概览
地位
招聘中
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
46
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Dr Shoaib Waqas, Phd
- 电话号码:+92 302 4552109
- 邮箱:shoaib.waqas@ubas.edu.pk
学习地点
-
-
Punjab Province
-
Lahore、Punjab Province、巴基斯坦、54000
- 招聘中
- Shareef Medical City Hospital
-
接触:
- Baseerat Iqbal, DPT, MSPT
- 电话号码:+923334705441
- 邮箱:ibaseerat@yahoo.com
-
首席研究员:
- Nargiza Saleem, Dpt
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
|
有源比较器: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quadriceps Muscle Strength
大体时间: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
大体时间: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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Dr Shaoib Waqas, Phd、Lahore University of Biological and Applied Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月28日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2026年11月25日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- UBAS/ERB/26/04/026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Baseline participants
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.