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Lo studio clinico NCT07236229 per Capsulite adesiva, Realtà virtuale, Sonno, Dolore, Cognizione è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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The Effects of Immersive Virtual Reality in Patients With Grade 1-2 Adhesive Capsulitis 36 Esercizio Virtuale
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La sperimentazione clinica NCT07236229 è uno studio interventistico per Capsulite adesiva, Realtà virtuale, Sonno, Dolore, Cognizione, attualmente in arruolamento. Avviato il 28 novembre 2025, prevede di arruolare 36 partecipanti. Sotto la guida di Bahçeşehir University, dovrebbe concludersi entro il 27 febbraio 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 1 dicembre 2025.
Sommario breve
Adhesive capsulitis (frozen shoulder) is a complex condition characterized by inflammation, fibrosis, and restriction of movement in the shoulder capsule, significantly limiting an individual's participation in daily living activities. It is most commonly observed in individuals aged between 40 and 60 years, and its treatment frequently involves approaches such as manual therapy, exercise, corticosteroid injections, ...Mostra di più
Descrizione dettagliata
Our study was designed as a single-center, randomized, controlled, prospective trial aiming to compare the effectiveness of immersive virtual reality-based exercise therapy and conventional therapy in patients diagnosed with Grade 1-2 adhesive capsulitis.Patients who consent to participate will be randomly assigned to two groups:
Intervention Group (n = 15): Patient education + Home exercise program + Immersive virt...
Mostra di piùTitolo ufficiale
The Effects of Immersive Virtual Reality-Based Exercise Therapy on Pain, Functionality, Sleep, and Cognitive Functions in Patients With Grade 1-2 Adhesive Capsulitis
Patologie
Capsulite adesivaRealtà virtualeSonnoDoloreCognizionePubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- BahcesehirU_H_AC-VR_01
Numero NCT
Data di inizio (effettiva)
2025-11-28
Ultimo aggiornamento pubblicato
2025-12-01
Data di completamento (stimata)
2026-02-27
Arruolamento (previsto)
36
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Adhesive Capsulitis
Virtual Reality
Sleep
Pain
Cognition
Virtual Reality
Sleep
Pain
Cognition
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleImmersive Virtual Reality-Based Exercise Therapy Participants in this group will receive immersive virtual reality-based exercise therapy using Oculus Quest 2 applications (Guided Tai Chi and Reach Shoulder Health) for 6 weeks, 2 sessions per week. | Immersive Virtual Reality-Based Exercise Therapy Patients in the immersive virtual reality-based exercise group will participate in the exercise program using the Oculus Quest 2 device. Sessions will be conducted twice a week for six weeks, each lasting 30 minutes. Two different virtual reality applications, Reach Shoulder Health and Guided Tai Chi, will be administered to the patients in this group.
In addition, both groups will receive identical patient educatio...Mostra di più |
Comparatore attivoConventional Physiotherapy Group Participants in this group will receive standard physiotherapy exercises for adhesive capsulitis including ROM, stretching, and strengthening for 6 weeks, 2 sessions per week. | Conventional Physiotherapy Group In the conventional exercise group, participants will perform range of motion exercises, pendulum exercises, finger ladder exercises, stretching, and strengthening exercises. The traditional exercise therapy will be administered twice a week for six weeks, with each session lasting 30 minutes.
In addition, both groups will receive identical patient education and home exercise programs. Patient education will be deli...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Pain intensity measured by the Visual Analog Scale (VAS) | The VAS assesses perceived shoulder pain intensity on a 10-cm line from "no pain" to "worst pain imaginable. | Baseline and at the end of the 6-week intervention period |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Shoulder Function (Shoulder Pain and Disability Index - SPADI) | Shoulder pain and disability will be assessed with the SPADI, which evaluates pain and functional limitation on a 0-100 scale, where higher scores indicate greater impairment. | Baseline and at the end of the 6-week intervention period |
Shoulder Range of Motion (ROM) | Shoulder joint mobility (flexion, extension, abduction, adduction, internal and external rotation) will be measured in degrees using a goniometer to evaluate changes in movement capacity. | Baseline and at the end of the 6-week intervention period |
Pain Catastrophizing (Pain Catastrophizing Scale - PCS) | Catastrophic thinking related to pain will be assessed using the PCS, which measures rumination, magnification, and helplessness. Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing. | Baseline and at the end of the 6-week intervention period |
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI) | The PSQI assesses sleep quality over the past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Component scores (0-3) are summed to yield a global score (0-21), with higher scores indicating poorer sleep quality (commonly, \>5 suggests poor sleep). | Baseline and at the end of the 6-week intervention period |
Digit Span Test | The Digit Span Test (DST) will be used to assess attention, short-term memory, and processing speed. It consists of two parts: Digit Span Forward (DSF) and Digit Span Backward (DSB). The total score ranges from 0 to 17 (maximum DSF = 9, DSB = 8). Higher scores indicate better verbal attention and short-term memory performance. | Baseline and at the end of the 6-week intervention period |
Wisconsin Card Sorting Test | Wisconsin Card Sorting Test (WCST) will be used to assess executive functions, including cognitive flexibility, abstract reasoning, and problem-solving ability. The primary outcome measures will include total errors, perseverative errors, and non-perseverative errors. Scores range from 0 to 128, with fewer errors indicating better executive functioning. | Baseline and at the end of the 6-week intervention period |
Benton Visual Retention Test | Benton Visual Retention Test (BVRT) will be used to assess short-term visual memory, visual perception, and visuoconstructive abilities. The version used in this study will be Form F, which will include 15 stimulus cards and 15 corresponding multiple-choice response cards.
Scores will be calculated as the number of correct responses, with a possible range of 0 to 15. Higher scores will indicate better visual memory performance. | Baseline and at the end of the 6-week intervention period |
Virtual Reality Discomfort Questionnaire | Virtual Reality Discomfort Questionnaire includes symptoms such as fatigue, eyestrain, headache, and dizziness. Each item is rated on a 4-point Likert-type scale ranging from 0 (never) to 3 (very often). The total score is obtained by summing all item scores and then converting it into a percentage for interpretation. Higher scores indicate a greater level of discomfort associated with virtual reality use. | At the end of the first Virtual Reality session |
Virtual Reality Satisfaction Questionnaire | Virtual Reality Satisfaction Questionnaire will be used to provide descriptive data to understand the contribution of the virtual reality experience to the therapeutic process and patient comfort. The questionnaire consists of a total of 10 items under four subdimensions: ease of use, visual/auditory experience, engagement/interest, and overall satisfaction. Each item will be rated on a 4-point Likert-type scale ranging from 0 (never) to 3 (very often). The total score will be obtained by summing all item scores and converting the result into a percentage for interpretation. Higher scores will indicate greater patient satisfaction with the virtual reality experience. | At the end of the first Virtual Reality session |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Diagnosed with adhesive capsulitis by a doctor
- Classified as Grade 1-2 adhesive capsulitis
- Receiving physiotherapy for adhesive capsulitis for the first time
- Aged between 18 and 64 years
- Suitable for using a VR headset
- Previous history of physiotherapy
- Presence of any mental disorder
- Recent surgery or any shoulder condition (e.g., fractures around the shoulder region) that contraindicates shoulder mobilization
- History of receiving injections
Parte responsabile dello studio
Hande Besna Göçen, Investigatore principale, Lecturer, MSc Physiotherapist, Bahçeşehir University
Contatti principali dello studio
Contatto: Hande B Gocen, PhD (c), 5313606135, [email protected]
Contatto: Selen Gur Ozmen, Assoc.Prof., 5323941011, [email protected]
1 Centri dello studio in 1 paesi
Istanbul
Kanuni Sultan Suleyman Training and Research Hospital, Küçükçekmece, Istanbul, 34519, Turkey (Türkiye)
Hande B Gocen, PhD (c), Contatto, 5313606135, [email protected]
In arruolamento