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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. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

46

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Punjab Province
      • Lahore, Punjab Province, Pákistán, 54000
        • Nábor
        • Shareef Medical City Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Nargiza Saleem, Dpt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Aktivní komparátor: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quadriceps Muscle Strength
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Ředitel studie: Dr Shaoib Waqas, Phd, Lahore University of Biological and Applied Sciences

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

28. července 2026

Primární dokončení (Odhadovaný)

1. října 2026

Dokončení studie (Odhadovaný)

25. listopadu 2026

Termíny zápisu do studia

První předloženo

17. června 2026

První předloženo, které splnilo kritéria kontroly kvality

17. června 2026

První zveřejněno (Aktuální)

23. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. července 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • UBAS/ERB/26/04/026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Baseline participants

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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