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Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation (BFR-TMR-ACL)

9. maj 2026 opdateret af: Ali Muslim Raza, Green International University

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:

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Green International University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BFR + TMR Group
Describe the Blood Flow Restruction and the Total Motion Release exercises
Enhed: 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."
Aktiv komparator: BFR Only Group
Describe only the blood flow restriction part.
Enhed: 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."

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Isometric Lower Limb Strength
Tidsramme: 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.
Basaeline, 6 weeks, 12 weeks and 6 months.
Single Leg Stance (SLS) Test Time
Tidsramme: 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.
Basaeline, 6 weeks, 12 weeks and 6 months.
Total Score of International Knee Documentation Committee (IKDC) Subjective Knee Form
Tidsramme: 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.
Baseline, 6 weeks, 12 weeks, and 6 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Green International University

Samarbejdspartnere

Sir Ganga Ram Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. november 2025

Primær færdiggørelse (Faktiske)

21. april 2026

Studieafslutning (Faktiske)

5. maj 2026

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

9. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GIU/REC/26-30 (Anden identifikator: Research Ethical Committee, Green International University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Only IDP used in the publication will be shared

IPD-delingstidsramme

It will be availabe after the completion of the study

IPD-delingsadgangskriterier

Through the corresponding author

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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