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COMPLETED
NCT07589309
NA

Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation

Sponsor: Green International University

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to compare the effectiveness of combined Blood Flow Restriction (BFR) and Total Motion Release (TMR) versus BFR alone in the restoration of muscular strength, balance and knee functionality in men and women aged 16 to 45 years who have undergone primary unilateral ACL reconstruction. The major research questions that it seeks to address are: Does the addition of TMR to a BFR protocol lead to significantly higher improvements in absolute quadriceps strength and subjective knee functioning as measured by IKDC scores? Does the combined protocol lead to better functional balance and symmetry in terms of the Single Leg Stance (SLS) test and Limb Symmetry Index (LSI)? The researchers will compare the BFR + TMR group to the BFR-only group to determine whether the integrated approach speeds up functional recovery and alleviates neuromuscular control deficits more effectively than strength-focused training alone. Participant TasksParticipants will: Undergo 3 sessions/week of supervised rehabilitation over a 6 month period. Complete Blood Flow Restriction (BFR) training consisting of low-load exercises (mini squats and knee extensions) with an inflatable cuff placed around the proximal part of the thigh at 60-80% occlusion pressure. Should there be in the experimental group, Total Motion Release (TMR) exercises (e.g., trunk rotations and hip shifts) on the contralateral side (i.e. non-painful side) to correct movement asymmetries before the BFR training. Baseline, 6 weeks, 12 weeks, and 6 months of complete subjective self-assessments (IKDC forms) and objective physical tests (dynamometer strength testing and single-leg balance tests).

Official title: Effects of Blood Flow Restriction With or Without Total Motion Release on Strength, Balance and Functional Disability in Postoperative ACL Injury

Key Details

Gender

All

Age Range

16 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2025-11-02

Completion Date

2026-05-05

Last Updated

2026-05-15

Healthy Volunteers

Yes

Interventions

DEVICE

Blood Flow Restriction

Blood Flow Restriction (BFR): Use the exact same cuff and pressure settings as Group 1 so the comparison is fair. The Exercises: List the specific movements (e.g., Straight Leg Raises, Quad sets, or Knee Extensions). The Difference: State clearly: "This group receives standard BFR training and traditional physical therapy without any TMR protocols."

PROCEDURE

Total Motion Release

Blood Flow Restriction (BFR): Specify the cuff type (e.g., automated or manual), the width of the cuff, and the pressure used (e.g., 80% of Limb Occlusion Pressure). Total Motion Release (TMR): Explain that you are using the "TMR protocol." Mention that you treat the "good" side or the "non-painful" side to influence the injured side. The Dose: How many minutes? How many times per week? (e.g., 30-minute sessions, 3 times per week for 12 weeks). The Difference: State clearly: "This group receives the TMR balancing protocol in addition to standard BFR training."

Locations (1)

Green International University

Lahore, Punjab Province, Pakistan