- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07792343
Effects of Balance Training on Balance and Fall Confidence After Hip Replacement Surgery
Effects of Perturbation-Based Balance Training on Balance Ability and Fall Efficacy in Patients After Total Hip Arthroplasty: A Randomized Controlled Trial
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Total hip arthroplasty (THA) is commonly performed to reduce pain and improve functional mobility in patients with hip joint disorders. However, many patients continue to experience impaired balance control, decreased proprioception, muscle weakness, and fear of falling after surgery. These impairments may negatively affect gait stability, activities of daily living, and quality of life.
Traditional balance training programs mainly focus on static posture control and predictable weight-shifting tasks. However, such approaches may not adequately improve reactive postural control required for unexpected balance disturbances encountered during daily activities. Perturbation-based balance training (PBT) has recently gained attention as an intervention designed to improve reactive balance control by exposing individuals to unexpected external disturbances and encouraging adaptive postural responses.
This study aims to investigate the effects of perturbation-based balance training using pressure biofeedback in patients following total hip arthroplasty. The pressure biofeedback system provides controlled instability and real-time sensory feedback during balance tasks, allowing participants to improve postural control strategies and weight-shifting ability.
Thirty patients who underwent THA will be recruited and randomly assigned to either an experimental group or a control group. The experimental group will receive perturbation-based balance training using pressure biofeedback in addition to conventional physical therapy, while the control group will perform conventional balance training with conventional physical therapy. Interventions will be performed 5 times per week for 6 weeks.
Outcome measures will include balance performance assessed by the Berg Balance Scale (BBS), Functional Reach Test (FRT), and center of pressure (COP) parameters measured using a Wii Balance Board. Falls efficacy will be evaluated using the Falls Efficacy Scale (FES). Hip function and lower extremity function will be assessed using the Harris Hip Score (HHS) and Lower Extremity Functional Scale (LEFS).
The findings of this study may provide evidence supporting the clinical applicability of perturbation-based balance training using pressure biofeedback as an effective rehabilitation strategy for improving postural stability and reducing fall risk after THA.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Gyeongsangbuk-do
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Gyeongsan-si, Gyeongsangbuk-do, Korea Południowa, 38453
- Daegu University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Patients who underwent total hip arthroplasty (THA)
- Postoperative period between 2 weeks and 6 months
- Ability to understand and follow therapist instructions
- Able to stand independently with or without an assistive device
- Berg Balance Scale (BBS) score between 21 and 45
- Receiving inpatient rehabilitation and physical therapy
Exclusion Criteria:
- Severe cognitive impairment (K-MMSE < 18)
- Severe visual impairment or vestibular dysfunction
- Any neurological or musculoskeletal disorder affecting balance other than THA
- Unstable cardiovascular or medical conditions that could interfere with participation
- Inability to safely participate in balance training
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Pressure Biofeedback-Based Perturbation Balance Training Group
Participants will receive perturbation-based balance training using pressure biofeedback in addition to conventional physical therapy.
The intervention will be conducted for 15 minutes per session, five times per week, for six weeks.
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Participants performed perturbation-based balance training using pressure biofeedback devices in addition to conventional physical therapy.
During standing tasks, pressure biofeedback units were placed under both feet, and temporary instability was induced by adjusting air pressure to alter support surface stability.
Participants performed progressive balance tasks including static standing, weight shifting, multidirectional reaching, and PNF-based reaching patterns.
Training intensity and task difficulty were progressively increased according to participant performance.
The intervention was conducted for 15 minutes per session, 5 sessions per week, for 6 weeks under therapist supervision.
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Aktywny komparator: Conventional Balance Training
Participants performed traditional balance training combined with conventional physical therapy.
Training included static and dynamic balance exercises, weight shifting, postural control tasks, and functional reaching activities without pressure biofeedback.
The intervention was conducted for 30 minutes per session, 5 sessions per week, for 6 weeks.
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Participants in the control group received traditional balance training without pressure biofeedback.
The intervention included static and dynamic balance exercises, postural control training, weight-shifting tasks, and posture transition activities.
The training tasks were performed in the same sequence and progression as the experimental group, but without perturbation induced by pressure biofeedback devices.
Participants received training for 30 minutes per session, 5 times per week, for 6 weeks in addition to conventional physical therapy.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Berg Balance Scale (BBS)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Functional balance assessed with the Berg Balance Scale, a 14-item performance-based scale scored from 0 to 56, with higher scores indicating better balance.
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Baseline and after 6 weeks of intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Functional Reach Test (FRT)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Maximum forward reach distance in centimetres while standing, measured with the Functional Reach Test; greater distance indicates better dynamic balance.
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Baseline and after 6 weeks of intervention
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Falls Efficacy Scale (FES)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Fall-related self-efficacy assessed with the Falls Efficacy Scale; higher scores indicate greater confidence in performing activities without falling.
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Baseline and after 6 weeks of intervention
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Harris Hip Score (HHS)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Hip function assessed with the Harris Hip Score, covering pain, function, deformity and range of motion, scored from 0 to 100, with higher scores indicating better hip function.
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Baseline and after 6 weeks of intervention
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Lower Extremity Functional Scale (LEFS)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Lower-limb function assessed with the Lower Extremity Functional Scale, a 20-item self-report questionnaire scored from 0 to 80, with higher scores indicating better function.
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Baseline and after 6 weeks of intervention
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Mean COP velocity, eyes open (cm/s)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Mean velocity of centre-of-pressure displacement during quiet standing with eyes open, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP root mean square distance, eyes closed (cm)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Root-mean-square distance of the centre-of-pressure from its mean position during quiet standing with eyes closed, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP 95% confidence ellipse area, eyes closed (cm^2)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Area of the 95% confidence ellipse fitted to the centre-of-pressure distribution during quiet standing with eyes closed, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP sway path length, eyes closed (cm)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Total length of the centre-of-pressure trajectory during quiet standing with eyes closed, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP mediolateral range, eyes closed (cm)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Range of centre-of-pressure excursion in the mediolateral direction during quiet standing with eyes closed, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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Mean COP velocity, eyes closed (cm/s)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Mean velocity of centre-of-pressure displacement during quiet standing with eyes closed, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP mediolateral range, eyes open (cm)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Range of centre-of-pressure excursion in the mediolateral direction during quiet standing with eyes open, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP sway path length, eyes open (cm)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Total length of the centre-of-pressure trajectory during quiet standing with eyes open, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP 95% confidence ellipse area, eyes open (cm^2)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Area of the 95% confidence ellipse fitted to the centre-of-pressure distribution during quiet standing with eyes open, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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COP root mean square distance, eyes open (cm)
Ramy czasowe: Baseline and after 6 weeks of intervention
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Root-mean-square distance of the centre-of-pressure from its mean position during quiet standing with eyes open, measured with a Nintendo Wii Balance Board and Balancia software; mean of three 30-second trials.
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Baseline and after 6 weeks of intervention
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Deok Hoon Jun, Daegu University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
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
Słowa kluczowe
Inne numery identyfikacyjne badania
- 1040621-202509-HR-074
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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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