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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorLahore University of Biological and Applied Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood Flow Restriction Training

    Other intervention

    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.

  • Instrument-Assisted Soft Tissue Mobilization (IASTM)

    Other 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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Group A: Blood Flow Restriction TrainingExperimental treatment 1 intervention
Group B: Group B : Instrument Assisted Soft Tissue MobilizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 8 weeks post-intervention
2

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).

Time frame
Baseline and 8 weeks post-intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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