- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gyeongsangbuk-do
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Gyeongsan-si, Gyeongsangbuk-do, 대한민국, 38453
- Daegu University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Berg Balance Scale (BBS)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional Reach Test (FRT)
기간: 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)
기간: 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)
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean COP velocity, eyes open (cm/s)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Deok Hoon Jun, Daegu University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1040621-202509-HR-074
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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