- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07697495
Scapulothoracic Stabilization and Postural Training in Upper Extremity Lymphedema
Effects of Scapulothoracic Stabilization and Postural Training Added to Standard Lymphedema Care on Muscle Strength, Posture and Functional Outcomes in Secondary Upper Extremity Lymphedema: A Single-Center Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Secondary upper extremity lymphedema is a common complication following breast cancer treatment and is characterized by chronic swelling, pain, reduced muscle strength, impaired upper extremity function, and postural alterations. These impairments may negatively affect daily activities, body perception, and quality of life. Although Complex Decongestive Therapy (CDT) is considered the gold standard for lymphedema management, conventional treatment primarily focuses on edema reduction and does not specifically address scapular stability, postural alignment, or neuromuscular control.
Altered scapulothoracic biomechanics and postural dysfunction are frequently observed in individuals with breast cancer-related lymphedema. These impairments may contribute to shoulder dysfunction, muscle weakness, compensatory movement patterns, and persistent functional limitations. Scapulothoracic stabilization exercises aim to restore scapular muscle balance and improve dynamic shoulder stability, whereas postural training promotes optimal alignment and body awareness. The combined application of these interventions may enhance functional recovery beyond the effects of standard CDT alone; however, evidence from randomized controlled trials remains limited.
This single-center, prospective, randomized controlled trial aims to evaluate the effectiveness of adding scapulothoracic stabilization and postural training to standard lymphedema care in women with secondary upper extremity lymphedema following breast cancer surgery. Participants will be randomly allocated to either a control group receiving standard lymphedema care or an intervention group receiving standard care plus scapulothoracic stabilization and postural training. Randomization will be performed using a computer-generated allocation sequence, and all outcome assessments will be conducted by a blinded assessor.
Outcome measures will be collected at baseline, immediately after completion of treatment, and at a 2-month follow-up. Primary and secondary outcomes will include scapular muscle strength measured with a handheld dynamometer (MicroFET2), postural alignment assessed using the PostureScreen application, upper extremity function evaluated with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, limb volume calculated from serial circumference measurements, and neck awareness assessed using the Fremantle Neck Awareness Questionnaire (FreNAQ). The findings of this study are expected to provide evidence regarding the clinical benefits of incorporating targeted scapulothoracic stabilization and postural training into conventional lymphedema rehabilitation and may contribute to the development of more comprehensive rehabilitation protocols for breast cancer survivors.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: İdil Esin Ünlü, Assist. Prof. Dr.
- Telefonnummer: +90 506 515 66 22
- E-mail: idil.unlu@toros.edu.tr
Studiesteder
-
-
-
Adana, Tyrkiet (Türkiye)
- Rekruttering
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Kontakt:
- Deniz TUNCA, PT
- Telefonnummer: +90 532 409 36 33
- E-mail: denizcanoglu82@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Female patients aged 18 to 65 years.
- Diagnosed with secondary upper extremity lymphedema following breast cancer surgery (mastectomy).
- Willing to participate in the study.
- Able to provide written informed consent.
Exclusion Criteria:
- Active infection (e.g., cellulitis or lymphangitis).
- Advanced shoulder or cervical pathology.
- Neurological disorders affecting upper extremity function.
- Metastatic disease.
- Receiving active chemotherapy.
- Participation in another intensive lymphedema rehabilitation program within the previous 3 months.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Scapulothoracic Stabilization
Participants assigned to the experimental group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with a structured scapulothoracic stabilization and postural training program.
The additional exercise program is designed to improve scapular muscle function, postural alignment, and upper extremity function.
Assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
|
Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
A supervised exercise program consisting of scapulothoracic stabilization exercises and postural training designed to improve scapular muscle strength, postural alignment, and upper extremity function.
The program will be provided in addition to standard Complex Decongestive Therapy throughout the treatment period.
|
|
Aktiv komparator: Control
Participants assigned to the control group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises according to routine clinical practice.
Outcome assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
|
Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Upper Extremity Function
Tidsramme: Baseline, immediately after completion of treatment, and 2 months after treatment
|
Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The DASH is a validated 30-item patient-reported outcome measure evaluating symptoms and functional limitations of the upper extremity.
Scores range from 0 to 100, with higher scores indicating greater disability.
|
Baseline, immediately after completion of treatment, and 2 months after treatment
|
|
Change in Head Anterior Translation
Tidsramme: Baseline, immediately after completion of treatment, and 2 months after treatment
|
Head anterior translation will be assessed using the PostureScreen mobile application.
|
Baseline, immediately after completion of treatment, and 2 months after treatment
|
|
Change in Shoulder Height Asymmetry
Tidsramme: Baseline, immediately after completion of treatment, and 2 months after treatment.
|
Shoulder height asymmetry will be assessed using the PostureScreen mobile application.
|
Baseline, immediately after completion of treatment, and 2 months after treatment.
|
|
Change in Shoulder Anterior Translation
Tidsramme: Baseline, immediately after completion of treatment, and 2 months after treatment.
|
Shoulder anterior translation will be assessed using the PostureScreen mobile application.
|
Baseline, immediately after completion of treatment, and 2 months after treatment.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Scapular Muscle Strength
Tidsramme: Baseline, immediately after completion of treatment, and 2 months after treatment
|
Scapular muscle strength (upper, middle, and lower trapezius muscles) will be measured using a handheld dynamometer (MicroFET2) with the isometric make-test method.
|
Baseline, immediately after completion of treatment, and 2 months after treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 25.02.2026-1214/23
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Complex Decongestive Therapy
-
SeppicAfsluttet
-
SeppicAfsluttetSunde frivilligeItalien
-
The Hospital for Sick ChildrenChildren's Hospital of Eastern Ontario; Montreal Children's Hospital of...AfsluttetMedicinsk Uddannelse | Børn med medicinsk kompleksitet | Kompleks pleje | Pædiatriske beboereCanada
-
Vora Life LLCKGK Science Inc.Ikke rekrutterer endnuSunde voksne | Sult | Mæthed | Højt BMICanada
-
SeppicAfsluttet
-
Roswell Park Cancer InstituteIncuronAfsluttetKlinisk fase III kutan melanom AJCC v8 | Patologisk trin IIIB kutan melanom AJCC v8 | Patologisk fase IIIC kutan melanom AJCC v8 | Klinisk fase IV kutan melanom AJCC v8 | Patologisk trin IV kutan melanom AJCC v8 | Stage III blødt vævssarkom i stammen og ekstremiteterne AJCC v8 | Stage IIIA blødt vævssarkom... og andre forholdForenede Stater
-
Gaziler Physical Medicine and Rehabilitation Education...RekrutteringLymfødem | Fysisk genoptræning | Gangdysfunktion | Kronisk ødemTyrkiet (Türkiye)
-
IRCCS Eugenio MedeaRekrutteringEpilepsi | Angelman syndrom | Dup15q syndromItalien
-
MSDx, Inc.Trukket tilbageMultipel scleroseForenede Stater
-
Ambrosia - SupHerb Ltd.Ukendt