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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.

2026년 7월 21일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

46

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Punjab Province
      • Lahore, Punjab Province, 파키스탄, 54000
        • 모병
        • Shareef Medical City Hospital
        • 연락하다:
        • 수석 연구원:
          • Nargiza Saleem, Dpt

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Quadriceps Muscle Strength
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Dr Shaoib Waqas, Phd, Lahore University of Biological and Applied Sciences

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 28일

기본 완료 (추정된)

2026년 10월 1일

연구 완료 (추정된)

2026년 11월 25일

연구 등록 날짜

최초 제출

2026년 6월 17일

QC 기준을 충족하는 최초 제출

2026년 6월 17일

처음 게시됨 (실제)

2026년 6월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 21일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Baseline participants

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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