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临床试验/NCT03812978
NCT03812978已完成不适用

Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.

Karolinska Institutet4 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2017年3月1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
101
试验地点
4
主要终点
Sport injury adherence scale (SIRAS)

研究概览

简要总结

Can a mobile application improve adherence, self-efficacy and range of motion after flexor tendon repair? A randomized controlled multicenter trial.

Aim Evaluate how the use of a mobile application will affect exercise adherence, range of motion and self-efficacy when compared to standard rehabilitation after flexor tendon repair. Method Multicenter randomized controlled trial. Patients with flexor tendon repair in zone I or II were included and rehabilitated with early active motion and followed 12 weeks post-surgery. Randomization was performed by a computer-generated concealed block to control (n=60) or intervention group (n=60). Both groups received standard rehabilitation according to early active motion. Intervention group also received a smart phone app including; exercise videos, push-notifications for exercise, exercise diary, written information on the surgery, rehabilitation, questions and answers. Evaluation was made at baseline, 2, 6- and 12-weeks after surgery. Primary outcome was physiotherapist rated adherence on the Sport Injury Adherence Scale (SIRAS). Secondary outcome was self-reported adherence, perceived self-efficacy, total Active range of motion (TAM) in the Proximal Interphalangeal (PIP) joint and Distal Interphalangeal (DIP) joint and perceived satisfaction with rehabilitation and information.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years old,
  • Own a mobile phone, fluent in Swedish,
  • Suited for early active motion rehabilitation
  • Injury to one or both of the flexor tendons in the a finger

排除标准

  • concomitant fracture in the hand
  • tendon injury to flexor pollicis longus.
  • Extensor tendon injury in the same hand.

研究组 & 干预措施

Control

No Intervention

Standard treatment

Intervention

Experimental

Standard treatment and intervention (Smart phone application)

干预措施: Smart phone application (Other)

结局指标

主要结局

Sport injury adherence scale (SIRAS)

时间窗: assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)

Physiotherapist rated adherence questionnaire

次要结局

  • Self reported adherence(assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome))
  • Range of motion(assessed at 12 weeks (range 0-240,higher value indicates better outcome ))
  • Athlet injury self efficacy questionnaire (AISEQ)(baseline, 2 and 6 weeks (Change over time))

研究者

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

Marianne Arner

Principal Investigator

Karolinska Institutet

研究点 (4)

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