跳至主要内容
临床试验/NCT06005857
NCT06005857招募中不适用

Use of Paper- Versus Digital Application-based Exercises to Support the Rehabilitation of People Operated by a Palmar Plate for an Intra-articular Distal Radius Fracture. A Multidisciplinary, Prospective, Randomized, Single-blind, Controlled Trial

Hôpital Fribourgeois2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月23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
40
试验地点
2
主要终点
Range of motion in flexion-extension

研究概览

简要总结

The aim of this study is to evaluate the difference between the use of paper- versus application-based (smartphone application) exercises in the rehabilitation of intra-articular fractures of the distal radius at the Cantonal Hospital of Fribourg, Switzerland.

The operation itself will proceed as usual. However, the rehabilitation will be aided by exercises based either on a paper support or on a digital application (smartphone application), in addition to follow-up by a hand therapist.

The aim is to determine which support provides the best improvement in wrist mobility and function, and to speed up the return to work.

详细描述

The aims of this study are:

  1. To measure range of motion (flexion and extension) of the wrist in usual post-operative hand therapy sustained by the use of a digital application-based home exercise program compared with usual post-operative hand therapy sustained by the use of paper-based (standard) home exercice program.
  2. To measure the following variables in usual post-operative hand therapy sustained by the use of a digital application-based home exercise program compared with usual post-operative hand therapy sustained by the use of paper-based (standard) home exercice program:
  • Patient-Rated Wrist Evaluation score
  • Return to work
  • Retorn to leisure
  • Range of motion in pronation and supination, in radial deviation and ulnar deviation
  • Distal radio-ulnar joint stability
  • Grip strength
  • Key pinch strength
  • Tripod pinch strength
  • Fracture healing
  • Fracture displacement
  • Patient satisfaction with exercise support
  • Patient participation in rehabilitation

Co-primary endpoint: range of motion (ROM) of the wrist, i.e. measured in degrees in flexion and extension.

Secondary endpoints:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Complete intra-articular DRF (classification AO 23 C1, C2 or C3)
  • Simple palmar operative approach
  • Simple palmar plate fixation
  • Age 18-65 years
  • Own either a smartphone or other wireless device
  • Consent form signed
  • French or German speaker

排除标准

  • Extra-articular or partial-articular DRF
  • Double/triple operative approaches needed
  • Bilateral procedure
  • Fracture aged than more of 2 weeks
  • Patient refusal/no informed consent
  • Inability to give informed consent
  • Previous wrist injury or surgery
  • Rheumatoid polyarthritis

结局指标

主要结局

Range of motion in flexion-extension

时间窗: From enrollment to the end of treatment at 3 months

Measurement (in degrees) of joint mobility using a goniometer

次要结局

  • Wrist fonction score(From enrollment to the end of treatment at 3 months)

研究者

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

Estoppey Daniel

Principal Investigator

Hôpital Fribourgeois

研究点 (2)

Loading locations...

相似试验