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临床试验/NCT05413031
NCT05413031已完成不适用

Treatment of Finger Extensor Tendon Rupture - Comparison Between Static and Relative Motion Splints

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年1月30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
26
试验地点
1
主要终点
Fingers range of motion

研究概览

简要总结

Different splints are used after hand extensor tendon repair (including relative motion splint, static splint, etc.) There is no consensus regarding the benefits of either one.

The aim of this study is to compare clinical outcomes after using different orthoses and rehabilitation methods after hand extensor tendon repair.

Patients are randomly assigned after signing consent to either immobilization with a static splint or a relative motion splint. Patients are examined after 2 and 5 months postoperatively for finger range of motion, grip strength, and DASH questionnaire.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with hand extensor tendon tear in zones 4-7 after surgical repair, that are able to sign a consent form.

排除标准

  • •patients that did not arrive for a follow-up meeting after 2 months.

研究组 & 干预措施

relative motion splint

Active Comparator

干预措施: relative motion splint (Device)

static splint

Active Comparator

干预措施: static splint (Device)

结局指标

主要结局

Fingers range of motion

时间窗: 5 months after surgical repair

Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.

Grip strength

时间窗: 5 months after surgical repair

Measured with the Jamar Hand Dynamometer

The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

时间窗: 5 months after surgical repair

The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

Grip strength

时间窗: 2 months after surgical repair

Measured with the Jamar Hand Dynamometer

Fingers range of motion

时间窗: 2 months after surgical repair

Range of motion in the Metacarpophalangeal joints, Proximal and Distal interphalangeal joints.

The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

时间窗: 2 months after surgical repair

The scale ranges from 0-to 100 and a higher score interprets as a worse outcome.

次要结局

  • Fingers range of motion(The change between 2 and 5 months after surgical repair)
  • Grip strength(The change between 2 and 5 months after surgical repair)
  • The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire(The change between 2 and 5 months after surgical repair)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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