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

NCT07662850 | Recruiting DMC

• 1 other identifier: UBAS/ERB/26/04/026
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Reconstruction

Keywords

Anterior Cruciate Ligament Reconstruction; Blood Flow Restriction Training; Instrument-Assisted Soft Tissue Mobilization; Quadriceps Strength; Range Of Motion; Pain; Kinesiophobia

Outcome Measures

Primary Outcomes (2)

• Quadriceps Muscle Strength

  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

  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

Study Arms (2)

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.

Other: Blood Flow Restriction Training

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.

Other: Instrument-Assisted Soft Tissue Mobilization (IASTM)

Interventions

Blood Flow Restriction Training OTHER

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.

Group A: Blood Flow Restriction Training

Instrument-Assisted Soft Tissue Mobilization (IASTM) OTHER

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.

Group B : Instrument Assisted Soft Tissue Mobilization

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• weeks after reconstructive surgery.
• Willing to comply with all rehabilitation sessions and follow up assessments; give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Shareef Medical City Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain; Kinesiophobia

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Dr Shaoib Waqas, Phd

  Lahore University of Biological and Applied Sciences

  STUDY DIRECTOR

Central Study Contacts

Dr Shoaib Waqas, Phd

CONTACT

+92 302 4552109; shoaib.waqas@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PA (1)