Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Dr Shoaib Waqas, Phd
- Telefonnummer: +92 302 4552109
- E-mail: shoaib.waqas@ubas.edu.pk
Studiesteder
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-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Rekruttering
- Shareef Medical City Hospital
-
Kontakt:
- Baseerat Iqbal, DPT, MSPT
- Telefonnummer: +923334705441
- E-mail: ibaseerat@yahoo.com
-
Ledende efterforsker:
- Nargiza Saleem, Dpt
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
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Aktiv komparator: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quadriceps Muscle Strength
Tidsramme: Baseline and 8 weeks post-intervention
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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.
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Baseline and 8 weeks post-intervention
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Pain Intensity
Tidsramme: Baseline and 8 weeks post-intervention
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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
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Dr Shaoib Waqas, Phd, Lahore University of Biological and Applied Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- UBAS/ERB/26/04/026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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