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- Klinische proef NCT07719725
Effects of Visual-Feedback Induced Therapy and Active Release Technique on Shoulder Pain, Lymphedema, and Functional Disability in Post-Mastectomy Patients.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Punjab Province
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Lahore, Punjab Province, Pakistan, 0000
- University of biological and applied sciences
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Actieve vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain intensity
Tijdsspanne: From enrollment to 6 weeks.
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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.
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Shoulder pain and disability
Tijdsspanne: From baseline to 6 weeks.
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The Shoulder Pain and Disability Index is a 13-item, patient-reported questionnaire.
Percentage score (0% to 100%).
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From baseline to 6 weeks.
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Limb volume
Tijdsspanne: From baseline to 6 weeks
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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
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- UBAS/ERB/26/043010
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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