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临床试验/NCT06299228
NCT06299228Unknown不适用

Sensorimotor Training and Hand Therapy Versus Traditional Hand Therapy Alone Following a Distal Radius Fracture With Volar Plate Fixation: A Randomized Controlled Trial

Hand Surgery Associates LLC2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Active Joint Position Sense (AJPS)

研究概览

简要总结

The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.

详细描述

The study is an interventional study investigating the effectiveness of sensorimotor activities in addition to traditional occupational therapy intervention versus traditional intervention only for patients following a distal radius fracture with volar plate fixation. A convenience sample of patients from 2 outpatient orthopedic hand therapy departments will be invited to participate in the study.

The treatment for both groups will be identical with one group receiving the addition of sensorimotor activities. Participants will be divided into one of the two groups. They will be made aware that at any point they can choose to no longer participate in the study, and it will not affect their treatment.

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

  • Distal radius fracture with volar plate fixation
  • Understand English
  • 18 years or older
  • Available to attend skilled occupational therapy visits a minimum of 1x per week.

排除标准

  • Prior surgery to the involved wrist/hand
  • Cognitive impairment
  • Distal radius fracture managed by casting or by another means of fixation

结局指标

主要结局

Active Joint Position Sense (AJPS)

时间窗: Baseline, 3 and 6 weeks

Range of motion measurement for the wrist, the measurements are recorded in degress of motion and the greater the number of degrees is reflective of greater sensorimotor deficit

次要结局

  • Patient Rated Wrist and Hand Evaluation(Baseline, 3 and 6 weeks)

研究者

发起方
Hand Surgery Associates LLC
申办方类型
Other
责任方
Sponsor

研究点 (2)

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