- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07575425
Effects of Mobilized Balance Platform Exercises on Balance Parameters in Patients With Knee Osteoarthritis
Effects of Mobilized Balance Platform Exercises on Balance Parameters, Functional Status, and Pain in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
This prospective single-blind randomized controlled study aims to investigate the effects of mobilized balance platform exercises on balance parameters, pain, functional status, fear of falling, and kinesiophobia in patients with knee osteoarthritis. A total of 36 patients diagnosed with knee osteoarthritis will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital.
Participants will be randomly assigned to one of two groups. The control group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises. The intervention group will receive the same conventional treatment in addition to mobilized balance platform exercises using the Huber 360 system.
Pain severity, functional status, balance parameters, fear of falling, and kinesiophobia will be evaluated before and after treatment by an assessor blinded to treatment allocation.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Sefa Gumruk Aslan
- Puhelinnumero: +903122911503
- Sähköposti: sefagumrukk@gmail.com
Opiskelupaikat
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-
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Ankara, Turkki (Türkiye)
- Rekrytointi
- Gaziler physical therapy and rehabilitation
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Ottaa yhteyttä:
- Sefa Gumruk Aslan
- Puhelinnumero: +903122911503
- Sähköposti: sefagumrukk@gmail.com
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Patients aged between 45 and 65 years
- Diagnosis of knee osteoarthritis classified as Kellgren-Lawrence grade 2 or 3
- Willingness to participate voluntarily in the study
Exclusion Criteria:
- Presence of orthopedic knee implants
- Kellgren-Lawrence grade 1 or grade 4 knee osteoarthritis
- Sensory impairment
- Diagnosis of malignancy
- Unhealed fractures
- Circulatory disorders
- Infection around the knee joint
- Severe hearing loss or visual impairment
- Cognitive impairment
- Uncontrolled hypertension or diabetes mellitus
- Vestibular disorders causing balance problems, such as vertigo
- Use of walking assistive devices such as canes or walkers
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: Conventional Physical Therapy
Participants in this group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program.
The home exercise program will include knee strengthening, balance, range of motion, proprioceptive, and stretching exercises, performed 3 days per week for 20 minutes.
|
Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
|
|
Kokeellinen: Mobilized Balance Platform Exercise
Participants in this group will receive conventional physical therapy including TENS in addition to mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive, balance, and neuromuscular exercises, performed 3 days per week for 20 minutes.
|
Participants will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises performed 3 times per week for 20 minutes.
Participants will perform mobilized balance platform exercises using the Huber 360 system.
The exercise protocol will include quadriceps and core strengthening, proprioceptive training, balance exercises, and neuromuscular exercises specifically designed for patients with knee osteoarthritis.
Sessions will be performed 3 times per week for 20 minutes.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Static and Dynamic Balance Parameters
Aikaikkuna: Before treatment and immediately after completion of the 8-week treatment program
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Balance performance will be assessed using the Huber 360 balance assessment system.
Measurements will include static balance with eyes open and eyes closed, single-leg balance performance, and limits of stability.
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Before treatment and immediately after completion of the 8-week treatment program
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Pain Severity Assessed by Visual Analog Scale (VAS)
Aikaikkuna: Before treatment and immediately after completion of the 8-week treatment program
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) for night pain, resting pain, and pain during movement.
Higher scores indicate greater pain severity.
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Before treatment and immediately after completion of the 8-week treatment program
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Functional Status Assessed by WOMAC
Aikaikkuna: Before treatment and immediately after completion of the 8-week treatment program
|
Functional status will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Higher scores indicate worse pain, stiffness, and functional limitation.
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Before treatment and immediately after completion of the 8-week treatment program
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Functional Mobility Assessed by Timed Up and Go Test
Aikaikkuna: Before treatment and immediately after completion of the 8-week treatment program
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Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test.
Shorter completion times indicate better functional mobility.
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Before treatment and immediately after completion of the 8-week treatment program
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Fear of Falling Assessed by the International Falls Efficacy Scale
Aikaikkuna: Before treatment and immediately after completion of the 8-week treatment program
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Fear of falling during activities of daily living will be evaluated using the International Falls Efficacy Scale.
Higher scores indicate greater concern about falling.
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Before treatment and immediately after completion of the 8-week treatment program
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Kinesiophobia Assessed by Tampa Scale for Kinesiophobia
Aikaikkuna: Before treatment and immediately after completion of the 8-week treatment program
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Fear of movement and reinjury will be evaluated using the Tampa Scale for Kinesiophobia.
Higher scores indicate greater fear of movement.
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Before treatment and immediately after completion of the 8-week treatment program
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Sefa Gümrük Aslan, gaziler physcial therapy and rehabilitation hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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