- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07581535
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability
4. juni 2026 oppdatert av: Simge Nur UNGAN, Izmir Katip Celebi University
Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals With Chronic Ankle Instability: A Randomized Controlled Trial
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals with Chronic Ankle Instability: A Randomized Controlled Trial
Studietype
Intervensjonell
Registrering (Antatt)
38
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Simge N UNGAN, Phsiotherapist
- Telefonnummer: +90 507 648 5776
- E-post: ungansimgenur@gmail.com
Studiesteder
-
-
Çiğli
-
Izmir, Çiğli, Tyrkia (Türkiye), 35650
- Rekruttering
- Izmir Katip Celebi University Physiotherapy and Rehabilitation Department
-
Ta kontakt med:
- Damla Karabay
- Telefonnummer: +902323293535
- E-post: damla.gulpinar@ikcu.edu.tr
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Diagnosed with unilateral chronic ankle instability (CAI) in accordance with the International Ankle Consortium recommendations
- A history of at least one significant lateral ankle sprain that occurred at least 12 months prior to participation, resulting in inflammatory symptoms such as pain and swelling and causing at least one day of interruption in physical activity
- A history of "giving way" and/or recurrent ankle sprains and/or a feeling of instability in the affected ankle within the past 6 months
- A Cumberland Ankle Instability Tool (CAIT) score of ≤ 25
Exclusion Criteria:
- History of surgery or fracture in the lower extremities or spine
- Acute musculoskeletal injury affecting other joints of the lower extremity within the past 3 months (e.g., sprains, fractures) that impaired joint integrity and function and caused at least one day of interruption in physical activity
- History of injection in the affected ankle
- History of ankle sprain in the affected extremity within the past 4 weeks
- Presence of systemic musculoskeletal disorders, neurological disorders, vestibular disorders, or any other condition that may affect balance or sensory function
- Previous participation in any rehabilitation program for the ankle or cervical region
- History of head or neck trauma or diagnosed pathology within the past 12 months
- History of neck pain greater than 3/10 in severity within the past 12 months
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Conventional Treatment + Cervical and Oculomotor Exercises
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
In addition, they will perform cervical stabilization and oculomotor exercises.
The intervention will be conducted for 4 weeks, with 3 sessions per week.
Participants will follow a home exercise program that includes ankle mobility, strengthening, balance, and oculomotor exercises on days when they do not attend the clinic.
|
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
In addition, they will perform cervical stabilization and oculomotor exercises.
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
|
|
Aktiv komparator: Conventional Treatment
Participants in the control group will receive a conventional rehabilitation program consisting of mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
The intervention will be conducted for 4 weeks, with 3 sessions per week.
Participants will follow a home exercise program that includes ankle mobility, strengthening and balance exercises on days when they do not attend the clinic.
|
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
In addition, they will perform cervical stabilization and oculomotor exercises.
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Y-Balance Test
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Dynamic balance performance assessed using balance tests (Y-Balance Test)
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Baseline and post-intervention (after 4 weeks)
|
|
Foot and Ankle Ability Measure (FAAM)
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Functional status assessed using the Foot and Ankle Ability Measure (FAAM) The daily living activities subscale contains 21 items; the minimum score is 0 and the maximum score is 84.
The sports subscale consists of 8 items; the minimum score is 0 and the maximum score is 32.
A higher score represents a higher level of physical function.
|
Baseline and post-intervention (after 4 weeks)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ankle Joint Position Error Test
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Ankle proprioception assessed using laser beam device joint position error (JPE) tests
|
Baseline and post-intervention (after 4 weeks)
|
|
Weight Bearing Lunge Test
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Ankle dorsiflexion range of motion will be assessed with the weight bearing lunge test
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Baseline and post-intervention (after 4 weeks)
|
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Computerized balance assessment
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Postural stability will be assessed using the Prokin Tecnobody balance assessment system.
|
Baseline and post-intervention (after 4 weeks)
|
|
Side Hop Test
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Side hop test will be used to assess the dynamic postural control capacity around the ankle.
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Baseline and post-intervention (after 4 weeks)
|
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Ankle Pain
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Ankle pain will be assessed using a visual analog scale (VAS).
The VAS is a scale ranging from 0 (no pain) to 10 (most severe pain), with higher scores indicating greater pain.
|
Baseline and post-intervention (after 4 weeks)
|
|
Cervical Joint Position Error Test
Tidsramme: Baseline and post-intervention (after 4 weeks)
|
Cervical proprioception will be assessed using the Cervical Joint Position Error Test.
|
Baseline and post-intervention (after 4 weeks)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Damla KARABAY, Assistant Professor, Izmir Katip Celebi University
- Hovedetterforsker: Simge N UNGAN, Physiotherapist (Bachelor), Izmir Katip Celebi University
- Studieleder: Sercan Çapkın, Associate Professor, İzmir Bakırçay University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
7. juni 2026
Primær fullføring (Antatt)
7. juni 2027
Studiet fullført (Antatt)
7. juni 2027
Datoer for studieregistrering
Først innsendt
29. april 2026
Først innsendt som oppfylte QC-kriteriene
6. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2586
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
A final decision regarding the sharing of individual participant data has not yet been made due to considerations related to data protection regulations.
If a decision to share is made in the future, only de-identified data relevant to the published results may be shared upon reasonable request and in accordance with applicable regulations.
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