- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07719725
Effects of Visual-Feedback Induced Therapy and Active Release Technique on Shoulder Pain, Lymphedema, and Functional Disability in Post-Mastectomy Patients.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Punjab Province
-
Lahore, Punjab Province, Pakistan, 0000
- University of biological and applied sciences
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Female patients aged 40-65 years.
- History of unilateral mastectomy performed at least 2 months prior.
- Persistent shoulder pain (Numeric Pain Rating Scale 4-7).
- Reduced shoulder range of motion or functional limitation affecting daily activities.
- Mild to moderate lymphedema of the affected upper limb .
Exclusion Criteria:
- History of neurological disorders affecting motor function (e.g., stroke, MS).
- Previous shoulder surgery unrelated to mastectomy.
- Active infection or open wounds in the affected limb.
- Already developed frozen shoulder in diabetic patient.
- Severe lymphedema requires intensive medical management.
- Cognitive impairment prevents participation in therapy.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Active Release Technique
Participants will receive a combination of conventional physiotherapy and Active Release Technique (ART) for 40-60 minutes per session, three times per week, over 6 consecutive weeks.
The conventional physiotherapy includes hot pack therapy for 15 minutes to reduce pain and improve tissue extensibility, followed by 25-30 minutes of exercise therapy.
Exercises target shoulder range of motion (flexion, abduction, external rotation), strengthening of rotator cuff and scapular stabilizers, stretching of pectoralis major and minor, deltoid, biceps, and upper trapezius, and functional tasks such as reaching, lifting, and daily activity simulations.
Exercises start with three repetitions and stretches held for 10-15 seconds, with weekly progression based on patient tolerance.
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Participants in the experiment group 1 will receive a combination of conventional physiotherapy and Active Release Technique (ART) for 40-60 minutes per session, three times per week, over 6 consecutive weeks.
The conventional physiotherapy includes hot pack therapy for 15 minutes to reduce pain and improve tissue extensibility, followed by 25-30 minutes of exercise therapy.
Exercises target shoulder range of motion (flexion, abduction, external rotation), strengthening of rotator cuff and scapular stabilizers, stretching of pectoralis major and minor, deltoid, biceps, and upper trapezius, and functional tasks such as reaching, lifting, and daily activity simulations.
Exercises start with three repetitions and stretches held for 10-15 seconds, with weekly progression based on patient tolerance.
|
|
Aktiv komparator: Visual-Feedback Induced Therapy
Participants in the experimental group 2 will receive the same conventional physiotherapy as the experimental group 1, plus Visual-Feedback Induced Therapy (VFIT) for 40-60 minutes per session, three times per week, for 6 weeks.
VFIT uses mirror during shoulder and upper-limb exercises, allowing patients to observe the unaffected limb performing movements while performing symmetrical movements with the affected limb.
Exercises focus on shoulder flexion, abduction, rotation, and functional reaching tasks, aiming to correct abnormal movement patterns, reduce compensatory strategies, and enhance central motor control.
|
Participants in the experimental group 2 will receive the same conventional physiotherapy as the experimental group 1, plus Visual-Feedback Induced Therapy (VFIT) for 40-60 minutes per session, three times per week, for 6 weeks.
VFIT uses mirror during shoulder and upper-limb exercises, allowing patients to observe the unaffected limb performing movements while performing symmetrical movements with the affected limb.
Exercises focus on shoulder flexion, abduction, rotation, and functional reaching tasks, aiming to correct abnormal movement patterns, reduce compensatory strategies, and enhance central motor control.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity
Tidsramme: From enrollment to 6 weeks.
|
Pain numeric scale: The Numeric Pain Rating Scale is an 11-point scale from 0 to 10 used to measure pain intensity. |
From enrollment to 6 weeks.
|
|
Shoulder pain and disability
Tidsramme: From baseline to 6 weeks.
|
The Shoulder Pain and Disability Index is a 13-item, patient-reported questionnaire.
Percentage score (0% to 100%).
|
From baseline to 6 weeks.
|
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Limb volume
Tidsramme: From baseline to 6 weeks
|
Lymphedema measuring tape: A lymphedema measuring tape is a used to measuring circumference of shoulder. Minimum: Grade 1 (Mild - less than 20% volume increase in the limb)Maximum: Grade 4 (Gigantic - massive deformity exceeding 50% to 100% volume increase) |
From baseline to 6 weeks
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Andre studie-ID-numre
- UBAS/ERB/26/043010
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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