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临床试验/NCT03937492
NCT03937492Unknown不适用

EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL

Ergoterapia Manoegomito Sagl0 个研究点目标入组 60 人开始时间: 2019年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Range Of Motion

研究概览

简要总结

The study would like show that patients who follow a protocol with GMI are less probability to develop CRPS

详细描述

Distal radius fractures (DRF) has a high frequency in adults. Studies show that the upper limb is frequently affected by CRPS, especially if is preceded by a fracture.

Recent studies suggest that changes in cortical structures can contribute to the onset of CRPS.

GMI is a approved and efficacy method in CRPS rehabilitation, because it trains modified cortical areas throught 3 stadies: left-right discrimination, visual motor imagery and mirror therapy.

Literature shows that there are any studies about GMI efficacy on prevention CRPS in DRF after surgery.

This study would like to demostrate that, appling GMI in the early stages of rehabilitation plus standard rehabilitation protocol of DRF after surgery, CRPS cases are reducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with distal radius fracture after surgery
  • 18 to 75 years old
  • Male and female

排除标准

  • uncompliants patients
  • patients with neurological disorders or cognitive impairment
  • patients with TFCC injury or both ulna and radius fractures
  • patients with visually impairment
  • patients who don't speak or understand oral and written italian language

研究组 & 干预措施

A group

Experimental

In this group patients follow standard treatment after radius fracture plus GMI procol

干预措施: GMI protocol (Other)

A group

Experimental

In this group patients follow standard treatment after radius fracture plus GMI procol

干预措施: Standard Rehabilitation Protocol (Other)

B group

Active Comparator

In this group patients follow standard treatment after radius fracture

干预措施: Standard Rehabilitation Protocol (Other)

结局指标

主要结局

Range Of Motion

时间窗: Baseline and 8 weeks

Change in active and passive range of motion about hand and wrist

次要结局

  • Patient-rated wrist/hand evaluation (prwhe)(Baseline and 8 weeks)
  • Jamar hand dynamometer(Baseline and 8 weeks)
  • McGill pain questionnaire(Baseline and 8 weeks)

研究者

发起方
Ergoterapia Manoegomito Sagl
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pagella Susanna

Principal Investigator

Ergoterapia Manoegomito Sagl

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