- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sefa Gumruk Aslan
- Telefonní číslo: +903122911503
- E-mail: sefagumrukk@gmail.com
Studijní místa
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Ankara, Turecko (Türkiye)
- Nábor
- Ankara Gaziler physical therapy and rehabilitation hospital
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Kontakt:
- Sefa Gumruk Aslan
- Telefonní číslo: +903122911503
- E-mail: sefagumrukk@gmail.com
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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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Experimentální: 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.
|
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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Lumbar Proprioception Assessment
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Severity Assessed by Visual Analog Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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