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临床试验/NCT06356766
NCT06356766招募中不适用

Investigation of Effectiveness of Modified Duran Protocol Via Telerehabilitation After Zone 2 Flexor Tendon Injury Repair of the Hand

Istanbul University2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2024年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
2
主要终点
Range of Motion

研究概览

简要总结

The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.

The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.

The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.

Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.

SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p <0.05 considered significant in all assessments, and accepted as two-tailed.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with isolated Zone 2 flexor digitorum profundus (FDP) and flexor digitorum superficialis (FDS) injuries,
  • Repair performed within the first 72 hours post-injury,
  • Individuals aged between 18 and 55 years,
  • Patients willing to participate in the study,
  • Ability to attend sessions regularly.

排除标准

  • Fingers with concomitant fractures, digital nerve injuries, vascular injuries, or significant skin loss accompanying flexor tendon injuries,
  • Bilateral flexor tendon injuries,
  • Patients with replantation or revascularization,
  • Flexor Pollicis Longus tendon injuries of the thumb due to differences in protocols applied and measurement of final outcomes,
  • Patients unable to understand and perform postoperative exercises

结局指标

主要结局

Range of Motion

时间窗: First week, 5th week, 6th week, 12th week

Modified Strickland Formula

次要结局

  • Pain of the affected hand(First week, 5th week, 6th week, 12th week)
  • Muscle Strength(12th week)
  • DASH(First week, 5th week, 6th week, 12th week)

研究者

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

Fatma Merih Akpınar

Assistant Professor

Istanbul University

研究点 (2)

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