| Registry | NCT07662850 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 46 (Actual) |
| Sponsor | Lahore University of Biological and Applied Sciences (Other) |
| Conditions | ACL Reconstruction |
| Interventions | Blood Flow Restriction Training, Instrument-Assisted Soft Tissue Mobilization (IASTM) (Other) |
| Dates | start 2026-06-26, primary completion 2026-09-30, completion 2026-11-28 (estimated), first posted 2026-06-23, last updated 2026-10-14 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for ACL Reconstruction All trials of Blood Flow Restriction Training All trials of Instrument-Assisted Soft Tissue Mobilization (IASTM)
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A: Blood Flow Restriction Training | Experimental | Other: 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. |
| Group B : Instrument Assisted Soft Tissue Mobilization | Active comparator | Other: Instrument-Assisted Soft Tissue Mobilization (IASTM) | 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. |
Sex: All, ages: 18 Years to 40 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Shareef Medical City Hospital | Lahore, Punjab Province | Pakistan |