- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07603609
Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain
Effects of a Sensorimotor Training Protocol Using a Mobilized Balance Platform on Proprioceptive System, Movement Control, and Quality of Life in Patients With Chronic Low Back Pain
This randomized controlled study aims to investigate the effects of a sensorimotor training protocol using a mobilized balance platform device on proprioceptive system function, movement control, balance, physical performance, pain severity, and quality of life in patients with chronic low back pain. A total of 44 patients with chronic low back pain will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital.
Participants will be randomly assigned to either a sensorimotor training group or a control group. The intervention group will receive sensorimotor training using the Huber 360 balance system, while the control group will perform a home exercise program including stretching, spinal mobility, lumbopelvic control, and balance exercises.
Pain severity, proprioception, functional status, balance, physical performance, and quality of life will be assessed before and after treatment by an assessor blinded to group allocation.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Sefa Gumruk Aslan
- Numer telefonu: +903122911503
- E-mail: sefagumrukk@gmail.com
Lokalizacje studiów
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Ankara, Turcja (Türkiye)
- Rekrutacyjny
- Ankara Gaziler physical therapy and rehabilitation hospital
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Kontakt:
- Sefa Gumruk Aslan
- Numer telefonu: +903122911503
- E-mail: sefagumrukk@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Individuals aged between 18 and 55 years
- Presence of chronic low back pain lasting at least 3 months
- Pain intensity score of 3 or higher on the Visual Analog Scale (VAS)
- Individuals with sufficient cognitive ability to understand and follow study procedures
- Willingness to participate voluntarily in the study
Exclusion Criteria:
- Participation in a similar training program within the last 12 months
- History of lower extremity or spinal surgery
- Presence of non-mechanical low back pain, inflammatory disease, or tumor
- Uncontrolled hypertension or cardiac disease
- History of malignancy
- Presence of radicular symptoms associated with low back pain
- Progressive neurological deficits
- Neurogenic claudication
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Home Exercise Program
Participants in this group will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
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Participants will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
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Eksperymentalny: Huber 360 Sensorimotor Training
Participants in this group will receive a sensorimotor training protocol using the Huber 360 balance system.
The intervention will include progressive rotational and oscillatory exercises aimed at improving proprioception, balance, neuromuscular control, and movement control.
Sessions will be performed for 30 minutes, twice weekly for 5 weeks.
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Participants will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
Participants will receive sensorimotor training using the Huber 360 balance system.
The protocol will include progressive rotational and oscillatory exercises designed to improve proprioception, balance, neuromuscular control, and movement control in patients with chronic low back pain.
Sessions will be performed for 30 minutes, twice weekly for 5 weeks.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Lumbar Proprioception Assessment
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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Lumbar proprioception will be assessed using lumbar repositioning tests at 60 degrees flexion and 15 degrees extension.
Participants will be asked to reproduce target lumbar positions, and the angular repositioning error will be recorded.
Lower repositioning error values indicate better lumbar proprioceptive accuracy.
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Before treatment and immediately after completion of the 5-week intervention program
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pain Severity Assessed by Visual Analog Scale
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain severity.
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Before treatment and immediately after completion of the 5-week intervention program
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Functional Status Assessed by Oswestry Disability Index
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI).
Higher scores indicate greater disability.
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Before treatment and immediately after completion of the 5-week intervention program
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Balance and Limits of Stability Assessed by Huber 360
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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Static balance, dynamic balance, and limits of stability will be assessed using the Huber 360 balance system.
Better balance performance and improved stability limits indicate better postural control.
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Before treatment and immediately after completion of the 5-week intervention program
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Lumbar Flexion Range of Motion
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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Physical performance will be assessed using a Physical Performance Test Battery including lumbar flexion range of motion, 50-step walking test, 5-minute walking test, five-repetition sit-to-stand test, ten-repetition trunk flexion test, and forward reaching with weight.
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Before treatment and immediately after completion of the 5-week intervention program
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Quality of Life Assessed by Short Form-36
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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Quality of life will be assessed using the Short Form-36 (SF-36).
Higher scores indicate better health-related quality of life.
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Before treatment and immediately after completion of the 5-week intervention program
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50-Step Walking Test
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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he time required to complete the 50-step walking test will be recorded in seconds
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Before treatment and immediately after completion of the 5-week intervention program
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Five-Minute Walking Test
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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The time required to complete five sit-to-stand repetitions will be recorded in seconds.
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Before treatment and immediately after completion of the 5-week intervention program
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Ten-Repetition Trunk Flexion Test
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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The time required to complete ten trunk flexion repetitions will be recorded in seconds.
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Before treatment and immediately after completion of the 5-week intervention program
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Forward Reaching with Weight Test
Ramy czasowe: Before treatment and immediately after completion of the 5-week intervention program
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Forward reaching distance while holding weight will be measured in centimeters.
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Before treatment and immediately after completion of the 5-week intervention program
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CLBP-MBP-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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