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临床试验/NCT06132646
NCT06132646尚未招募不适用

Effectiveness of a Global Proprioceptive Training After Wrist Fracture

University of Malaga0 个研究点目标入组 28 人开始时间: 2024年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
28
主要终点
Change in function related with daily living activities

研究概览

简要总结

The goal of this randomized clinical trial is to compare how a program of proprioceptive exercises for the wrist could influence in pain, functionality and quality of life in people that have suffered a wrist fracture. The main questions it aims to answer are:

  • Evaluate the effect of a specific proprioceptive program on pain and functionality.
  • Study the relationship between proprioception deficit and functionality.

Intervention will be:

  • Control group: participants of this group are going to receive only standard rehabilitation program after wrist fracture.
  • Experimental group: participants of this group are going to receive standard rehabilitation program after distal radius fracture and a specific proprioceptive program.

Researchers will compare control and experimental group to see if a implantation of a proprioceptive program for the wrist has benefits on pain, function and quality of life.

详细描述

Distal radius fracture (DRF) is one of the most frequent injuries in the upper limb, corresponding to 1/6 of the total fractures of the body. It appears mostly in >50 years old women (due to osteoporosis and menopause) but it is also frequent in middle age men as a consequence of a big trauma during sport activities or working. This injury can be treated conservative of surgically, but regardless of the treatment, it always has a period of immobilization between 3 and 6 weeks.

The term "proprioception" was firstly described by Sherrington in 1906 as "perception" of body position and movement. The presence and quantity of mechanoreceptors in the joint determine its proprioceptive capacity. In the 1990s, the presence of mechanoreceptors on the wrist was described, and subsequent studies allowed us to determine that the dorsal and ulnar ligaments of the wrist have a rich innervation of mechanoreceptors. With these findings, we can hypothesize various clinical applications, both for working on wrist proprioception in the early stages of proprioceptive reeducation without risking tissue damage and for neuromuscular work after fracture consolidation, with the goal of regaining fluid and balanced movement. Previous studies on the ankle, knee, and shoulder have shown that the implementation of a proprioceptive program in the rehabilitation process can improve traumatic instability and pain. Given that the wrist shares similarities with these joints in terms of proprioceptive innervation, we can hypothesize that a specific proprioceptive exercise program for the wrist may be beneficial in the recovery after a wrist fracture.

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
Single (Participant)

盲法说明

Participants will be anonymized with a number and randomized with a web program (random.org)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (equal or more than 18 y/o).
  • Suffering a wrist fracture and have passed immobilization period.
  • Agree and sign informed consent.

排除标准

  • Not had suffered a wrist fracture, being in the immobilization period or not authorized by his/her orthopedic surgeon to start with rehabilitation.
  • Suffer any mental, cognitive, neurological or musculoskeletal disorder.
  • Previous injury or pathology of the upper limb affected.
  • Previos surgery on the upper limb affected.
  • Have cervical pathology/impairment.
  • Suffering from blindness.

结局指标

主要结局

Change in function related with daily living activities

时间窗: Baseline, 4 weeks and 3 months.

Measured with QuickDASH. 11 items, 0=no disability and 100= total disability

Change in perception of pain, referred to wrist

时间窗: Baseline, 4 weeks and 3 months

Pain measured with Numerical Rating Scale (NRS) 0= no pain and 10=worst pain

Change in hand and wrist function related with difficulties in performing daily living activities

时间窗: Baseline, 4 weeks and 3 months

Measured with Patient-rated wrist evaluation (PRWE). 15 items in 2 subscales, function (10 items) and pain (5 items). Punctuation could be from 0 to 50 in each subscale, where 50 points means worse pain/function.

次要结局

  • Change in strength(Baseline, 4 weeks and 3 months.)
  • Change in Perception of Quality of life(Baseline, 4 weeks and 3 months)
  • Changes in proprioception, position terms(Baseline, 4 weeks and 3 months)
  • Change in range of motion of the wrist(Baseline, 4 weeks and 3 months.)
  • Changes in proprioception, strength terms(Baseline, 4 weeks and 3 months)

研究者

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

Leire Cruz-Gambero

Principal Investigator

University of Malaga

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