- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: İdil Esin Ünlü, Assist. Prof. Dr.
- Telefonnummer: +90 506 515 66 22
- E-post: idil.unlu@toros.edu.tr
Studiesteder
-
-
-
Adana, Tyrkia (Türkiye)
- Rekruttering
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Ta kontakt med:
- Deniz TUNCA, PT
- Telefonnummer: +90 532 409 36 33
- E-post: denizcanoglu82@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 25.02.2026-1214/23
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Sekundært lymfødem
-
National Cancer Institute, EgyptFullførtBenneoplasma, ondartet vertebral kolonne Thoracic SecondaryEgypt
Kliniske studier på Complex Decongestive Therapy
-
Cairo UniversityFullført
-
University of SalamancaFullførtLymfeødem | Cellulitt i beinet | Vene sykdomSpania
-
SeppicFullført
-
SeppicFullførtFriske FrivilligeItalia
-
Seton Healthcare FamilyUniversity of Texas at AustinFullførtLivskvalitet | Kronisk sykdom | Kronisk sykdomForente stater
-
University of California, Los AngelesRekrutteringKronisk sykdomForente stater
-
Roswell Park Cancer InstituteIncuronAvsluttetKlinisk stadium III kutant melanom AJCC v8 | Patologisk stadium IIIB kutant melanom AJCC v8 | Patologisk stadium IIIC kutant melanom AJCC v8 | Klinisk stadium IV kutant melanom AJCC v8 | Patologisk stadium IV kutant melanom AJCC v8 | Stage III bløtvevssarkom i stammen og ekstremiteter AJCC v8 | Stage... og andre forholdForente stater
-
SeppicFullført
-
Unity Health TorontoHar ikke rekruttert ennåPolyp kolorektal
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinFullførtArvelig epidermolysis BullosaFrankrike