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临床试验/NCT05148585
NCT05148585Unknown不适用

Efficacy Of Activity-Based Intervention On Activity, Participation And Kinesiophobia In Patients With Flexor Tendon Injury

Pamukkale University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
The Canadian occupational performance measure

研究概览

简要总结

The aim of our study is to determine the effect of activity-based intervention on the activity, participation levels and kinesiophobia (fear of movement) of the patients by evaluating the person, environment and activity using the Person-Environment-Occupation model (PEO) in the rehabilitation of hand forearm flexor tendon injuries.

详细描述

Our study will be carried out on housewives who were operated by Pamukkale University Education, Application and Research Center Directorate Orthopedics and Traumatology and Plastic, Reconstructive and Aesthetic Surgery Services due to flexor tendon injury in the forearm or hand.

Patients will be evaluated at the 7th, 12th and 24th weeks post-operatively, before the start of the post-operative physiotherapy program.

The data obtained from the study will be analyzed with the PASW Statistics 18 Release 18.0.0 program. Whether the data fit the normal distribution will be determined using the Shapiro-Wilk test. If parametric conditions are not met, Wilcoxon Signed Rank Test and Friedman Analysis of Variance will be used for intragroup comparisons, and Mann-Whitney U Test will be used for intergroup comparisons. Statistical significance level will be taken as p<0.05.

The physiotherapy program will start the post-operative first week for both group. Activity-based therapy group will have activity exercises that is meaningful for the patients, once a week one hour addition to the physiotherapy.

Patients to be included in groups were randomized in a single block order using Random Allocation Software 1.0.0.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Those between the ages of 18-65
  • flexor tendon injury
  • Primary tendon repair performed

排除标准

  • Presence of major nerve injury (radial, ulnar, median nerve)
  • Presence of concomitant injuries (fracture, joint injury, ligament injury)
  • Presence of any previous or ongoing orthopedic, neurological, rheumatological and metabolic disease or disorder in the relevant extremity

结局指标

主要结局

The Canadian occupational performance measure

时间窗: six month

The Canadian occupational performance measure, was used to determine the effect of the intervention on the participant's self-determined occupational performance goals. A scale of one to ten was used, where ten was the most important goal needed to be attained by the participants. Using the same scale, the participants were asked to rate the performance of the occupations and satisfaction with their performance. Both the sum of performance and satisfaction scores were divided by the number of identified problems to compute the overall score for analysis.

Tampa Kinesiophobia Scale

时间窗: six month

It is a 17-item scale developed to measure fear of movement and/or (re) injury. A high score indicates a high level of kinesiophobia. A score of \<37 indicates low kinesiophobia, and a score≥37 indicates a high level of kinesiophobia.

次要结局

  • grip strength(6 month)
  • jebsen taylor hand function test(six month)
  • Visual Analog Scale(7 weeks)
  • range of motion(six month)
  • Michigan Hand Outcome Questionnaire:(six month)

研究者

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

Sumeyye Cildan Uysal

MSc

Pamukkale University

研究点 (1)

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