- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Gyeongsangbuk-do
-
Gyeongsan-si, Gyeongsangbuk-do, Corée du Sud, 38453
- Daegu University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Berg Balance Scale (BBS)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Functional Reach Test (FRT)
Délai: Baseline and after 6 weeks of intervention
|
Maximum forward reach distance in centimetres while standing, measured with the Functional Reach Test; greater distance indicates better dynamic balance.
|
Baseline and after 6 weeks of intervention
|
|
Falls Efficacy Scale (FES)
Délai: Baseline and after 6 weeks of intervention
|
Fall-related self-efficacy assessed with the Falls Efficacy Scale; higher scores indicate greater confidence in performing activities without falling.
|
Baseline and after 6 weeks of intervention
|
|
Harris Hip Score (HHS)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
Lower Extremity Functional Scale (LEFS)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean COP velocity, eyes open (cm/s)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP root mean square distance, eyes closed (cm)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP 95% confidence ellipse area, eyes closed (cm^2)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP sway path length, eyes closed (cm)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP mediolateral range, eyes closed (cm)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
Mean COP velocity, eyes closed (cm/s)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP mediolateral range, eyes open (cm)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP sway path length, eyes open (cm)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP 95% confidence ellipse area, eyes open (cm^2)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
|
COP root mean square distance, eyes open (cm)
Délai: Baseline and after 6 weeks of intervention
|
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.
|
Baseline and after 6 weeks of intervention
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Deok Hoon Jun, Daegu University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 1040621-202509-HR-074
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .