Determination of the Minimal Clinically Important Difference of the Push-Off Test in Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Range of Motion (ROM) Measurement
研究概览
简要总结
The aim was to determine the minimal clinically important difference of the push-off test in distal radius fractures.
详细描述
To interpret a treatment effect and a change that is meaningful for the patient, it is important to use the minimal clinically important difference (MCID) of the push-off test (POT). The MCID represents the smallest numerical change that can be perceived as beneficial by the patient. A numerical change smaller than the MCID, even if statistically significant, does not represent a clinically meaningful change. Because the MCID defines a difference that is considered important for patients, it can also serve as a basis for estimating the required sample size in the design of future studies.
Another important metric is the minimal detectable change (MDC). The MDC represents the smallest amount of change that exceeds the measurement error of an instrument. Therefore, any change smaller than the MDC may be the result of measurement variability. To ensure that the MDC is sufficiently small to detect the MCID, the MCID should be greater than the MDC. The MDC of the POT has been investigated in patients with wrist or elbow pathologies; however, to date, the MCID has not been established in patients with distal radius fractures.
In summary, the POT is a test that objectively evaluates axial loading of the upper extremity in the presence of hand or wrist pathology. However, to ensure the reliability of preliminary findings and to support its integration into hand therapy practice, further studies are needed to evaluate its measurement properties using specific patient samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of distal radius fracture (DRF) and treatment with either conservative or surgical methods
- •Voluntary participation
- •Age between 18 and 65 years
- •Having a cognitive level sufficient to understand the assessment methods and follow instructions
排除标准
- •Presence of concomitant musculoskeletal or neurovascular injuries in the affected extremity
- •Presence of a neurological, orthopedic, rheumatologic, or metabolic condition that could affect the affected extremity
研究组 & 干预措施
All patients
All patients diagnosed with distal radius fractures who were treated conservatively or surgically
干预措施: Physical therapy (Other)
结局指标
主要结局
Range of Motion (ROM) Measurement
时间窗: Assessments will be performed at the 12th and 18th weeks after the fracture.
Forearm pronation and supination, as well as wrist flexion, extension, radial deviation, and ulnar deviation, will be measured using a universal goniometer.
Patient-Rated Wrist Evaluation (PRWE)
时间窗: Assessments will be performed at the 12th and 18th weeks after the fracture.
The questionnaire assesses the severity of wrist pain and the level of disability in activities of daily living. It consists of two subscales comprising a total of 15 items. The pain subscale includes questions related to pain intensity and frequency, while the function subscale consists of six items related to specific activities and four items related to usual daily activities.
Push-Off Test (POT)
时间窗: Assessments will be performed at the 12th and 18th weeks after the fracture.
The POT determines the amount of force that an individual can transmit through the upper extremity. The measurement is performed using a hand dynamometer with the dynamometer handle inverted. The test is conducted while the participant is standing at the edge of a high table, and compensatory movements are not permitted. The tested extremity is positioned with the shoulder in approximately 30° of extension, the elbow in 30° of flexion, and the forearm, wrist, and hand positioned in a manner comfortable for the individual. Measurements are repeated three times for each extremity, and the mean value is recorded in kilograms.
Gross Grip Strength Test
时间窗: Assessments will be performed at the 12th and 18th weeks after the fracture.
Grip strength is measured using a hand dynamometer in accordance with the standard measurement protocol of the American Society of Hand Therapists.
次要结局
未报告次要终点
研究者
HANDE USTA
Assistant Professor
Pamukkale University