Mid-term Efficacy and Results of Postoperative Relaxation and Underfloor Classical Massage Methods and Training in Proximal Femur Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Sole sensory testing with Semmes-Weinstein Monofilament
研究概览
简要总结
The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology Service of Muğla Sıtkı Koçman University Training and Research Hospital and who have undergone proximal femur fracture surgery and meet the study criteria. It is aimed to investigate the mid-term efficacy of relaxation exercises and classical massage of the sole of the foot applied in addition to the conventional physiotherapy program in the postoperative in-hospital period in patients with proximal femur fracture.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 50 years and older who were diagnosed with proximal femur fracture and underwent surgery
- •No medical contraindications that would limit the ability to exercise
- •Having a caregiver who can supervise the exercise program after discharge
- •To be able to understand simple commands and to have signed the consent form
排除标准
- •Patients with pathological fractures and/or multiple fractures
- •Those with serious early complications
- •Terminally ill patients
- •Circumstances that would interfere with conducting assessments or communicating
- •Lack of cooperation during the study
- •Scoring ≤14 on the Mini Mental State Examinatio
结局指标
主要结局
Sole sensory testing with Semmes-Weinstein Monofilament
时间窗: Change from Baseline Semmes-Weinstein Monofilament Test at 3 days
The filament is imposed horizontally against the skin until there is a visible bending of the fiber. The patient then verbally assesses whether the sensation is perceived. Starting with the thinnest filament, thick filament is used sequentially until the patient feels it.
Hospital Anxiety and Depression Scale (HADS)
时间窗: Change from Baseline HADS at 3 days
The HADS consists of two subscales, one with seven items measuring anxiety and the other with seven items measuring depression, which are scored separately. Each item is answered by the patient on a 4-point response category (0 to 3), so that possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. 0 to 7 is considered "normal", 8 to 10 "mild", 11 to 14 "moderate" and 15 to 21 "severe".
Nottingham Hip Fracture Score (NHFS)
时间窗: Change from Baseline NHFS at 3 days
The Nottingham Hip Fracture Score is an aggregate score of seven preoperative variables that gives an estimated risk of 30-day postoperative mortality using a standard logistic regression. This score is calculated based on age, gender, comorbidities, place of residence (i.e. home or institutional care), abbreviated mental test score (AMTS) and hemoglobin level at admission. Higher scores indicate better condition.
Barthel Index (BI)
时间窗: Change from Baseline BI at 3 days
The Barthel Index was developed as a measure to assess disability in patients with neuromuscular and musculoskeletal disorders undergoing inpatient rehabilitation. A maximum total score of 100 can be obtained. Higher score indicates better condition.
EQ-5D-3L Quality of Life Scale
时间窗: Change from Baseline EQ-5D-3L at 3 days
The EQ-5D-3L provides information on three aspects of quality of life. Each dimension has three levels of impairment: no problems (level 1), some problems (level 2) and extreme problems (level 3). The score ranges from less than 0 to 1 (where 0 is a health status equivalent to death and negative values are worse than death) and 1 is the most positive score (the best perceived level according to the five dimensions included in the scale). Finally, the EQ VAS score is obtained by asking patients to rate their health status on a 20 cm vertical scale. The scale ranges from 0 to 100, with 0 meaning "worst imaginable health" and 100 meaning "best imaginable health".
Tampa Scale for Kinesiophobia (TSK)
时间窗: Change from Baseline TSK at 3 days
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Visual Analog Scale (VAS)
时间窗: Change from Baseline VAS at 3 days
On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).
次要结局
未报告次要终点
研究者
Fatih Ozden
Assistant Professor
Muğla Sıtkı Koçman University