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临床试验/NCT05821335
NCT05821335尚未招募不适用

The Development and Investigation of Effectiveness of Leap Motion Based Gamefication Exercises in Hand Rehabilitation of the Individuals With Systemic Sclerosis

Istanbul University0 个研究点目标入组 32 人开始时间: 2023年5月30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
32
主要终点
modified Hand Mobility in Scleroderma (mHAMIS)

研究概览

简要总结

Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis

详细描述

The aim of this project is to develop Leap Motion Sensor-assisted rehabilitation games that can be easily applied in hand rehabilitation in individuals with SSc, motivating, directing to the right exercise, providing therapeutic evaluation and feedback during the game, and comparing the effectiveness of these rehabilitation games with traditional rehabilitation applications.

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 (Outcomes Assessor)

盲法说明

Assessment and treatment will be done by different investigators.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having the ability to adapt to exercises
  • Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods

排除标准

  • Having a diagnosis of juvenile-onset SSc
  • Having a history of neurological disease or trauma that will affect hand functions
  • Receiving another treatment, such as intra-articular injection, surgery, that may affect hand rehabilitation in the last 6 months
  • Having systemic involvement that may affect the treatment process or activities of daily living

结局指标

主要结局

modified Hand Mobility in Scleroderma (mHAMIS)

时间窗: change from baseline at 5 weeks

Hand Mobility in Scleroderma is a hand function test developed for adults who have systemic sclerosis. HAMIS consists of 9 items designed to measure all movements assessed in an ordinary range of motion-measured hand test. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The total score of HAMIS for each hand is 370 Sandqvist and Eklund Vol. 13, No. 6, December 2000 27, which represents a high degree of dysfunction.

次要结局

  • Skin Hardness(change from baseline at 5 weeks)
  • Grip Strength(change from baseline at 5 weeks)
  • Finger Joint Range of Motion(change from baseline at 5 weeks)
  • Purdue Pegboard Test(change from baseline at 5 weeks)

研究者

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

Tugba Civi Karaaslan

Research Assistant

Istanbul University - Cerrahpasa (IUC)

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