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

NCT07589309 | Completed DMC

• 1 other identifier: GIU/REC/26-30
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

ACL Injury; ACL Reconstruction

Keywords

Anterior Cruciate Ligament (ACL); Blood Flow Restriction (BFR); Total Motion Release (TMR); Anterior Cruciate Ligament Reconstruction (ACLR)

Outcome Measures

Primary Outcomes (3)

• Maximum Isometric Lower Limb Strength

  Maximum isometric force of the affected limb measured using a hand-held dynamometer. This assesses the recovery from muscle atrophy and the return of power during the rehabilitation period.

  Basaeline, 6 weeks, 12 weeks and 6 months.

• Single Leg Stance (SLS) Test Time

  The duration a participant can stand unassisted on the injured leg without moving or compensating. This test determines the regain of static balance and proprioception.

  Basaeline, 6 weeks, 12 weeks and 6 months.

• Total Score of International Knee Documentation Committee (IKDC) Subjective Knee Form

  The IKDC Subjective Knee Form is a patient-reported outcome measure used to assess functional disability. It combines 18 items covering three domains: symptoms, physical activity, and knee function. All individual items are summed and transformed into a total score. A score of 100 indicates no limitation in activities of daily living or sports, while a score of 0 indicates maximum limitation. This measure provides a single aggregated value of the participant's self-reported functional status.

  Baseline, 6 weeks, 12 weeks, and 6 months.

Study Arms (2)

BFR + TMR Group

EXPERIMENTAL

Describe the Blood Flow Restruction and the Total Motion Release exercises

Device: Blood Flow Restriction; Procedure: Total Motion Release

BFR Only Group

ACTIVE COMPARATOR

Describe only the blood flow restriction part.

Device: Blood Flow Restriction

Interventions

Blood Flow Restriction DEVICE

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."

BFR + TMR Group; BFR Only Group

Total Motion Release PROCEDURE

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."

BFR + TMR Group

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 16-45 years.
• Both male and female patients.
• Underwent primary unilateral ACL reconstruction (hamstring or patellar tendon autograft).
• weeks post-operative and cleared for supervised rehabilitation.
• Willing and able to provide informed consent.

You may not qualify if:

• Revision ACL surgery or multi-ligament injury.
• Concomitant fracture or meniscal repair requiring restricted rehab.
• History of DVT, vascular disease, uncontrolled hypertension, or cardiovascular disease.
• Neurological disorders affecting lower limb strength or balance.
• Contraindications to BFR (pregnancy, clotting disorders).

Sponsors & Collaborators

• Green International University: lead
• Sir Ganga Ram Hospital: collaborator

Study Sites (1)

Green International University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 15, 2026
• Study Start: November 2, 2025
• Primary Completion: April 21, 2026
• Study Completion: May 5, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: It will be availabe after the completion of the study
• Access Criteria: Through the corresponding author

Locations

PA (1)