ACL InjuryBFR-TMR-ACLNCT07589309
Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation
A study testing Blood Flow Restriction and Total Motion Release in people with ACL Injury and ACL Reconstruction, run by Green International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, ACL Reconstruction
- What is being tested?
- Blood Flow Restriction and Total Motion Release
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Nov 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-45 years.
- Both male and female patients.
- Underwent primary unilateral ACL reconstruction (hamstring or patellar tendon autograft).
- 2-4 weeks post-operative and cleared for supervised rehabilitation.
- Willing and able to provide informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blood Flow Restriction With or Without Total Motion Release on Strength, Balance and Functional Disability in Postoperative ACL Injury
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:
Read more
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).
Read the detailed description
Evaluate and compare the effectiveness of Blood Flow Restriction (BFR) therapy as a single intervention against a combined protocol of Blood Flow Restriction and Total Motion Release (BFR+TMR) in men and women aged 16-45 who had undergone primary unilateral ACL reconstruction. The study aimed to address persistent deficits in quadriceps strength, neuromuscular control, and movement symmetry that often remain after standard rehabilitation.
The main questions it aimed to answer were:
Did the integration of TMR-a method focused on movement symmetry-into a BFR protocol lead to superior improvements in absolute quadriceps strength and subjective knee function as measured by IKDC scores? Did the combined BFR+TMR protocol result in significantly better functional balance and limb symmetry compared to BFR training alone? Researchers compared a BFR+TMR experimental group to a BFR-only control group. The primary objective was to see if the combined approach, which targeted both peripheral muscle capacity (via BFR) and central neuromotor control (via TMR), provided a more holistic and accelerated recovery than targeting muscular adaptations alone.
Complete a 6-month rehabilitation program consisting of supervised sessions three times per week.
Perform Blood Flow Restriction (BFR) training on the affected limb using an inflatable cuff at 60-80% occlusion pressure during low-load resistance exercises such as mini squats and knee extensions.
If assigned to the experimental group, perform Total Motion Release (TMR) exercises (including trunk rotations, side bending, and hip shifts) on the non-painful, contralateral side prior to the strengthening exercises.
Undergo periodic assessments including isometric strength testing with a dynamometer, the Single Leg Stance (SLS) test for balance, and the completion of the IKDC Subjective Knee Form.
Maintain a record of progress across four specific time points: baseline, 6 weeks, 12 weeks, and 6 months.
- Conditions
- ACL Injury, ACL Reconstruction
- Being tested
- Blood Flow Restriction, Total Motion Release
- Keywords
- Anterior Cruciate Ligament (ACL), Blood Flow Restriction (BFR), Total Motion Release (TMR), Anterior Cruciate Ligament Reconstruction (ACLR)
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
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."
Total Motion ReleaseProcedure or surgery
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."
| Study group | Role | What they receive |
|---|---|---|
| BFR + TMR Group | Experimental | Describe the Blood Flow Restruction and the Total Motion Release exercises Receives: Device: Blood Flow Restriction; Procedure: Total Motion Release |
| BFR Only Group | Active comparator | Describe only the blood flow restriction part. Receives: Device: Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks, 12 weeks, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start2 Nov 2025
- Primary completion21 Apr 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green International University
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Ganga Ram Hospital
- Responsible party
- Principal investigator, Ali Muslim Raza, Green International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589309
- Sponsor's protocol ID
- GIU/REC/26-30
- Other IDs
- GIU/REC/26-30
- Acronym
- BFR-TMR-ACL
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IDP used in the publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction With or Without Total Motion Release on Strength, Balance and Functional Disability in Postoperative ACL Injury
- ClinicalTrials.gov ID
- NCT07589309
- Acronym / sponsor ID
- BFR-TMR-ACL / GIU/REC/26-30
- Conditions
- ACL Injury, ACL Reconstruction
- Keywords
- Anterior Cruciate Ligament (ACL), Blood Flow Restriction (BFR), Total Motion Release (TMR), Anterior Cruciate Ligament Reconstruction (ACLR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Green International UniversityUniversity, hospital or other
- Collaborators
- Sir Ganga Ram Hospital
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Evaluate and compare the effectiveness of Blood Flow Restriction (BFR) therapy as a single intervention against a combined protocol of Blood Flow Restriction and Total Motion Release (BFR+TMR) in men and women aged 16-45 who had undergone primary unilateral ACL reconstruction. The study aimed to address persistent deficits in quadriceps strength, neuromuscular control, and movement symmetry that often remain after standard rehabilitation.
The main questions it aimed to answer were:
Did the integration of TMR-a method focused on movement symmetry-into a BFR protocol lead to superior improvements in absolute quadriceps strength and subjective knee function as measured by IKDC scores? Did the combined BFR+TMR protocol result in significantly better functional balance and limb symmetry compared to BFR training alone? Researchers compared a BFR+TMR experimental group to a BFR-only control group. The primary objective was to see if the combined approach, which targeted both peripheral muscle capacity (via BFR) and central neuromotor control (via TMR), provided a more holistic and accelerated recovery than targeting muscular adaptations alone.
Complete a 6-month rehabilitation program consisting of supervised sessions three times per week.
Perform Blood Flow Restriction (BFR) training on the affected limb using an inflatable cuff at 60-80% occlusion pressure during low-load resistance exercises such as mini squats and knee extensions.
If assigned to the experimental group, perform Total Motion Release (TMR) exercises (including trunk rotations, side bending, and hip shifts) on the non-painful, contralateral side prior to the strengthening exercises.
Undergo periodic assessments including isometric strength testing with a dynamometer, the Single Leg Stance (SLS) test for balance, and the completion of the IKDC Subjective Knee Form.
Maintain a record of progress across four specific time points: baseline, 6 weeks, 12 weeks, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR + TMR Group | Experimental | Device: Blood Flow Restriction, Procedure: Total Motion ReleaseDescribe the Blood Flow Restruction and the Total Motion Release exercises |
| BFR Only Group | Active comparator | Device: Blood Flow RestrictionDescribe only the blood flow restriction part. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 16-45 years.
- Both male and female patients.
- Underwent primary unilateral ACL reconstruction (hamstring or patellar tendon autograft).
- 2-4 weeks post-operative and cleared for supervised rehabilitation.
- Willing and able to provide informed consent.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow RestrictionBlood 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." | Device | BFR + TMR Group, BFR Only Group |
| Total Motion ReleaseBlood 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." | Procedure or surgery | BFR + TMR Group |
Primary outcome
Maximum Isometric Lower Limb Strength
Time frame: Basaeline, 6 weeks, 12 weeks and 6 months.
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.
Single Leg Stance (SLS) Test Time
Time frame: Basaeline, 6 weeks, 12 weeks and 6 months.
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.
Total Score of International Knee Documentation Committee (IKDC) Subjective Knee Form
Time frame: Baseline, 6 weeks, 12 weeks, and 6 months.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. Only IDP used in the publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction and Total Motion Release in people with ACL Injury and ACL Reconstruction, run by Green International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Isometric Lower Limb Strength (time frame: Basaeline, 6 weeks, 12 weeks and 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.