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临床试验/NCT04071002
NCT04071002已完成不适用

Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture

Pamukkale University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2015年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Visual Analogue Scale

研究概览

简要总结

Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.

详细描述

Distal radius fracture (DRF) affects overall health status. The International Classification of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this study was to investigate functional status and activity participation levels of DRF patients.

The patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. The evaluation of the body function and structure were done with Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic evaluations were done. Activity participation assessments were done with Push-Off Test (POT), Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical significance level was p<0,05.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 60
  • Diagnosed with distal radius fracture
  • Primary fixation after injury.

排除标准

  • Bilateral distal radius fracture
  • Concomitant ulna styloid fracture
  • Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb
  • Patients who underwent surgery that involved ipsilateral upper extremity
  • Associated injuries such as nerve or tendon injuries
  • Secondary procedures at follow-up
  • Un-cooperated patients.

研究组 & 干预措施

surgical group

Active Comparator

distal radius fractures that treated volar plate

干预措施: 12 weeks physical therapy programme (Other)

conservative group

Active Comparator

distal radius fractures that treated plaster of paris

干预措施: 12 weeks physical therapy programme (Other)

结局指标

主要结局

Visual Analogue Scale

时间窗: six month

To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.

algometer

时间窗: six month

An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .

radiographic evaluations

时间窗: six month

The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.

Michigan Hand Outcomes Questionnaire (MHOQ)

时间窗: six month

MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.

range of motion

时间窗: six month

An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm.

Jebsen-Taylor Hand Function Test (JTHFT)

时间窗: six month

The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.

grip strength

时间窗: six month

Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation.

Push-Off Test (POT)

时间窗: six month

POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.

Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)

时间窗: six month

It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity.

次要结局

未报告次要终点

研究者

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

HANDE USTA

Principal Investigator, Research Assistant

Pamukkale University

研究点 (2)

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