Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
研究概览
简要总结
A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.
详细描述
The purpose of this prospective study
To develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures.
- Standardization of initial evaluation for fall and re-fracture risks before rehabilitation
- Standardization in initial screening for prevention for common complication after fracture and early diagnosis
- Evidence based standardization in rehabilitation after fragility fracture
- Development for safe return to normal daily life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
- •Type of surgery : Bipolar hemiarthroplasty, THA, ORIF
排除标准
- •Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
- •Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
- •Combined multiple fracture (ex. Upper extremity)
- •Revision operation
- •Disagree to participation for clinical trial
- •Severe cognitive dysfunction (Obey command ≤1)
结局指标
主要结局
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation
时间窗: 0, 3 month, 6 month, 12 month
range, 0 to 5; decreasingly worse
次要结局
- Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines mobility status (KOVAL) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines hand grip strength after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation(0, 3 month, 6 month, 12 month)
- Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation(0, 3 month, 6 month, 12 month)
研究者
Jae-Young Lim
Professor, Department of Rehabilitation Medicine
Seoul National University Bundang Hospital