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- Klinische proef NCT07662850
Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.
21 juli 2026 bijgewerkt door: Prof. Dr. Shoaib Waqas, Lahore University of Biological and Applied Sciences
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Anterior cruciate ligament reconstruction (ACLR) is a commonly performed surgical procedure to restore knee stability following ACL injury.
Despite surgical success, many patients experience persistent quadriceps weakness, pain, reduced range of motion (ROM), and psychological barriers such as kinesiophobia, which can delay functional recovery and return to activity.
Optimizing early rehabilitation strategies is therefore essential to improve both physical and psychological outcomes after ACLR.
Blood Flow Restriction Training (BFR) and Instrument-Assisted Soft Tissue Mobilization (IASTM) are two emerging rehabilitation techniques increasingly used in musculoskeletal and postoperative care.
BFR involves the application of controlled external pressure to partially restrict blood flow during low-load resistance exercise, thereby promoting muscle strength and hypertrophy with minimal mechanical stress.
This makes it particularly suitable during early rehabilitation phases when high-load exercises may be contraindicated.
IASTM is a manual therapy technique that utilizes specialized instruments to mobilize soft tissues, improve circulation, reduce pain, and enhance tissue extensibility.
It is commonly used to address soft tissue restrictions, improve joint mobility, and support functional recovery.
Although both interventions have demonstrated beneficial effects independently, there is limited comparative evidence evaluating their relative effectiveness in patients undergoing ACLR.
Additionally, most previous studies have focused primarily on physical outcomes such as strength and ROM, with limited attention to psychological factors such as kinesiophobia, which play a critical role in rehabilitation success and return-to-sport readiness.
This study is designed as a two-arm parallel-group randomized clinical trial to compare the effects of BFR and IASTM on pain, quadriceps strength, knee ROM, and kinesiophobia in patients following ACLR.
A total of 46 participants, 8-16 weeks post-surgery, will be recruited and randomly allocated into either the BFR group or the IASTM group using a computer-generated randomization method with allocation concealment.
Participants in both groups will receive interventions twice weekly for 8 weeks, in addition to standard postoperative physiotherapy.
The BFR group will perform low-load quadriceps strengthening exercises under individualized occlusion pressure, while the IASTM group will receive structured soft tissue mobilization using specialized tools along with conventional rehabilitation exercises.
Outcome measures will include quadriceps muscle strength assessed using a handheld dynamometer, pain intensity measured with the Numeric Pain Rating Scale (NPRS), knee ROM assessed using a goniometer, and kinesiophobia evaluated using the Tampa Scale of Kinesiophobia (TSK-17).
Assessments will be conducted at baseline and after completion of the intervention period by blinded outcome assessors.
The findings of this study will provide comparative evidence regarding the effectiveness of BFR and IASTM in improving both physical and psychological outcomes during early rehabilitation after ACLR.
This may assist clinicians in selecting the most appropriate adjunctive treatment to optimize recovery and enhance return-to-function in this patient population.
Studietype
Ingrijpend
Inschrijving (Geschat)
46
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Dr Shoaib Waqas, Phd
- Telefoonnummer: +92 302 4552109
- E-mail: shoaib.waqas@ubas.edu.pk
Studie Locaties
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Werving
- Shareef Medical City Hospital
-
Contact:
- Baseerat Iqbal, DPT, MSPT
- Telefoonnummer: +923334705441
- E-mail: ibaseerat@yahoo.com
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Hoofdonderzoeker:
- Nargiza Saleem, Dpt
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 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).
- Active knee flexion of ≥100° on the operative limb.
- 8-16 weeks after reconstructive surgery.
- Willing to comply with all rehabilitation sessions and follow up assessments; give informed consent
Exclusion Criteria:
- 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
- Skin lesions preventing IASTM
- Pregnancy
- Contraindications to exercise
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group A: Blood Flow Restriction Training
Participants in this group will be allocated to the Blood Flow Restriction Training group as part of a randomized parallel study design.
This group represents one of the two comparative rehabilitation arms in post-ACLR patients.
Allocation to this arm is based on computer-generated randomization with concealed assignment.
Participants in this arm will be evaluated for physical and psychological outcomes as part of the study protocol.
The group will be followed for the full study duration alongside the comparison arm.
|
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.
|
|
Actieve vergelijker: Group B : Instrument Assisted Soft Tissue Mobilization
Participants in this group will be assigned to the Instrument-Assisted Soft Tissue Mobilization (IASTM) arm as part of a randomized parallel-group study design.
This arm represents the comparative rehabilitation approach for post-ACLR patients.
Allocation is performed using computer-generated randomization with concealed assignment.
Participants will be assessed for pain, strength, range of motion, and kinesiophobia as part of the study outcomes.
The group will follow the study protocol for the full intervention period alongside the comparison arm.
Outcome assessments will be conducted at baseline and post-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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quadriceps Muscle Strength
Tijdsspanne: Baseline and 8 weeks post-intervention
|
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.
|
Baseline and 8 weeks post-intervention
|
|
Pain Intensity
Tijdsspanne: Baseline and 8 weeks post-intervention
|
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).
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Baseline and 8 weeks post-intervention
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Dr Shaoib Waqas, Phd, Lahore University of Biological and Applied Sciences
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
28 juli 2026
Primaire voltooiing (Geschat)
1 oktober 2026
Studie voltooiing (Geschat)
25 november 2026
Studieregistratiedata
Eerst ingediend
17 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juni 2026
Eerst geplaatst (Werkelijk)
23 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
21 juli 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Psychische aandoening
- Fobische stoornissen
- Angst stoornissen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Kinesiofobie
- Pijn
- Therapeutica
- Modaliteiten fysiotherapie
- Patiëntenzorg
- Transporttherapie
- Revalidatie
- Nazorg
- Continuïteit van patiëntenzorg
- Bloedstroombeperkingstherapie
Andere studie-ID-nummers
- UBAS/ERB/26/04/026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Baseline participants
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .