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Comparison of Supervised Rehabilitation and Home Exercise Programs in Subacromial Impingement Syndrome (SAIS-REHAB)

5 mei 2026 bijgewerkt door: Merve Kurt-Aydin, Izmir Katip Celebi University

Comparison of the Effectiveness of a Physiotherapist-Supervised Rehabilitation Program and Home Exercise Education in Subacromial Impingement Syndrome

This randomized controlled trial aims to compare the effectiveness of physiotherapist-supervised rehabilitation and home exercise programs in individuals with subacromial impingement syndrome (SAIS). SAIS is a common musculoskeletal disorder characterized by shoulder pain, reduced range of motion, and functional limitations, negatively affecting quality of life.

Participants diagnosed with SAIS will be randomly assigned to one of three groups: a supervised rehabilitation group, a home exercise group, or a control group. Randomization will be performed using an online randomization tool. Individuals in the supervised rehabilitation group will receive a structured physiotherapy program administered by a physiotherapist, while those in the home exercise group will perform a standardized exercise program at home following initial instruction. Participants in the control group will not receive any intervention during the study period and will be assessed only.

Outcome measures including pain intensity, upper extremity function, range of motion, grip strength, sleep quality, and quality of life will be evaluated at baseline and after the intervention period. The results of this study are expected to provide evidence regarding the comparative effectiveness of supervised and home-based exercise approaches in the management of SAIS.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Subacromial impingement syndrome (SAIS) is one of the most common causes of shoulder pain, leading to decreased range of motion, muscle weakness, functional limitations, and reduced quality of life. Exercise-based rehabilitation is considered a primary conservative treatment approach. However, access to supervised physiotherapy services may be limited due to long waiting times and healthcare system constraints. Home exercise programs may serve as an alternative, but evidence comparing their effectiveness with supervised rehabilitation remains limited.

This study is designed as a randomized controlled trial to compare the effectiveness of physiotherapist-supervised rehabilitation and home exercise programs in individuals with SAIS. A total of 63 participants who meet the inclusion criteria will be recruited and randomly assigned into three groups: supervised rehabilitation, home exercise, and control.

Randomization will be performed using an online randomization tool. Participants allocated to the supervised rehabilitation group will receive a structured rehabilitation program consisting of pain management modalities, range of motion exercises, strengthening exercises, and functional training under the supervision of a physiotherapist, five days per week for four weeks. The home exercise group will receive a structured exercise program including stretching, strengthening, and mobility exercises after a single training session and will continue the program independently at home. Participants in the control group will not receive any intervention during the study period and will be included in the supervised rehabilitation program after the final assessment.

Outcome measures will include pain intensity assessed by Visual Analog Scale, upper extremity function assessed by the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH), shoulder range of motion measured by goniometer, grip strength measured by dynamometer, sleep quality assessed by a single-item sleep quality scale, and quality of life assessed by the WHOQOL-BREF. Assessments will be conducted at baseline and at the end of the 4-week intervention period.

The findings of this study will contribute to the literature by providing evidence on the comparative effectiveness of supervised rehabilitation and home-based exercise programs and may guide clinical decision-making in the management of SAIS.

Studietype

Ingrijpend

Inschrijving (Geschat)

63

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
    • Kırşehir
      • Kırşehir, Kırşehir, Turkije (Türkiye), 40100
        • Werving
        • Kırşehir Ahi Evran University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • Voluntary participation in the study
  • Literate in Turkish
  • Aged between 30 and 65 years
  • No visual or hearing impairment
  • Diagnosed with unilateral subacromial impingement syndrome by a specialist physician
  • Positive painful arc test, Infraspinatus test, and Hawkins-Kennedy test
  • Pain during overhead activities

Exclusion Criteria:

  • Presence of a mental or psychological disorder that may affect study findings
  • Inadequate cooperation
  • History of upper extremity fracture within the last 6 months
  • Presence of cervical neurological symptoms
  • Glenohumeral instability
  • Acromioclavicular joint pathology
  • Full-thickness rotator cuff tear or total rupture
  • Signs of glenohumeral osteoarthritis
  • History of frozen shoulder

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Supervised Rehabilitation
Participants in this group will receive a physiotherapist-supervised rehabilitation program five days per week for four weeks. The program will include pain management approaches, stretching exercises, range of motion exercises, scapular stabilization exercises, strengthening exercises, and activity modification training according to standard physiotherapy procedures.
Gedragsmatig: Supervised Rehabilitation Program
A physiotherapist-supervised rehabilitation program including pain management approaches, stretching exercises, range of motion exercises, scapular stabilization exercises, strengthening exercises, and activity modification training administered five days per week for four weeks.
Experimenteel: Home Exercise Program
Participants in this group will receive a structured home exercise program after an education session. The program will include stretching, range of motion, scapular stabilization, and strengthening exercises to be performed independently at home for four weeks.
Gedragsmatig: Home Exercise Program
A structured home exercise program including stretching, range of motion, scapular stabilization, and strengthening exercises performed independently at home for four weeks following an education session.
Geen tussenkomst: Control
Participants in this group will not receive any intervention during the four-week study period. Baseline and follow-up assessments will be performed. Individuals who are required to wait more than four weeks before starting physiotherapy sessions will be included in this group.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity
Tijdsspanne: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Pain intensity will be assessed using the Visual Analog Scale (0-10 cm) during rest, activity, and night pain. Higher scores indicate greater pain severity.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Upper Extremity Function
Tijdsspanne: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand Questionnaire-Short Form (DASH-SF; 0-100). Higher scores indicate greater disability.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Shoulder Range of Motion
Tijdsspanne: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Shoulder flexion, extension, abduction, internal rotation, and external rotation range of motion will be measured using a universal goniometer.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Grip Strength
Tijdsspanne: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Grip strength of the affected upper extremity will be assessed using a hand dynamometer.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Sleep Quality
Tijdsspanne: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Sleep quality will be assessed using the Single-Item Sleep Quality Scale (0-10). Higher scores indicate poorer sleep quality.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Quality of Life-WHOQOL-BREF
Tijdsspanne: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Quality of life will be assessed using the WHOQOL-BREF questionnaire. Higher scores indicate better quality of life
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Izmir Katip Celebi University

Medewerkers

Kirsehir Ahi Evran Universitesi

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 december 2025

Primaire voltooiing (Geschat)

2 september 2026

Studie voltooiing (Geschat)

2 september 2026

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2520

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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