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临床试验/NCT03618576
NCT03618576Unknown不适用

Effectiveness of the Computerized Balance Rehabilitation After Hip Fracture Surgery

Seoul National University Hospital0 个研究点目标入组 40 人开始时间: 2018年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Change of Berg balance scale

研究概览

简要总结

The overall functional gain by balance rehabilitation after hip fracture surgery has not yet been fully investigated. Therefore, clinical studies should be conducted to evaluate the effectiveness of systematic and safe balance rehabilitation in patients after hip fracture. Investigators aim to evaluate the effect of computer-based balance specific exercise on the performance and balance ability of the elderly women who underwent hip fracture surgery. Investigators also investigate the intervention can reduce their fear of falling and coping ability. This study was designed as a prospective, open-label, single-center trial at a tertiary hospital setting. During the 2-week postoperative intervention period, patients will participate in the hospital's exercise program beginning 5-7 days after hip fracture surgery. All participants will follow the computer-based balance specific exercise program. Functional outcomes will be measure periodically for 6 months after surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Elderly female patients (≥ 65 years old) who have undergone surgery for femoral neck, intertrochanteric, or subtrochanteric fracture, regardless of surgery type (internal fixation, bipolar hemiarthroplasty, or total hip arthroplasty)

排除标准

  • hip surgery for infection, arthritis, implant loosening, or avascular necrosis;
  • femoral shaft fracture, acetabular fracture, isolated fracture of the greater or lesser tuberosity, or periprosthetic fracture;
  • pathologic fracture;
  • combined multiple fracture;
  • revision surgery;
  • severe cognitive dysfunction (obey command ≤ 1 step);
  • cannot stand by supporting a fixed walker at 5 days after operation;
  • patients who refuse to participate in a clinical trial

研究组 & 干预措施

Balance exercise group

Experimental

During the 2-week postoperative intervention period, patients will participate in the hospital's exercise program beginning 5-7 days after HFS. All participants will follow the computer-based balance specific exercise (BSE) program.

干预措施: Balance specific exercise (Procedure)

结局指标

主要结局

Change of Berg balance scale

时间窗: Change from Baseline Berg balance scale at 6 months

Berg balance scale (total score; 0 to 56)

次要结局

  • Functional Ambulatory Category(Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery)
  • Short physical performance scale(Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery)
  • Functional Independence Measure: locomotion(Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery)
  • Modified falls efficacy scale(Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery)
  • Presence of Fear of falling(Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery)
  • Modified Barthel index(Before intervention, After 2 weeks' intervention, 3 and 6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Yoon Lee

Associate Professor

Seoul National University Hospital

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