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临床试验/NCT04684225
NCT04684225已完成不适用

Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma

Istanbul University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Hand Mobility in Scleroderma (HAMIS)

研究概览

简要总结

Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma

详细描述

The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of home-exercises.

Firstly, the evaluation results will be published; and after all data are collected, the results will be published.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with scleroderma
  • Stability of medical treatments
  • To be able to adapt to the exercises

排除标准

  • The patient has a history of neurological disease or trauma that may affect his symptoms
  • Systemic involvement that affects the treatment process
  • Being in the active phase of the disease

研究组 & 干预措施

Telerehabilitation

Experimental

Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients via telerehabilitation for 3 sessions per week.

干预措施: Hand Therapy via Telerehabilitation (Other)

Home-exercises

Experimental

Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied by their own at home for 3 sessions per week.

干预措施: Hand Therapy via home-exercises (Other)

Control

No Intervention

They will have no intervention for 8 weeks. After the period, they will do home exercises.

结局指标

主要结局

Hand Mobility in Scleroderma (HAMIS)

时间窗: change from baseline at 8 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

  • 9-Hole Peg Test(change from baseline at 8 weeks)
  • Scleroderma Health Assessment Questionnaire (SHAQ)(change from baseline at 8 weeks)
  • Semmes Weinstein Monofilaman Test(change from baseline at 8 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)

研究点 (1)

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