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临床试验/NCT05080738
NCT05080738已完成不适用

Investigation of Upper Extremity Home Exercises Effects on Grip Strength, Range of Motion, Activity Performance and Funcionality in Patients With Scleroderma

Pamukkale University2 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Activity Performance

研究概览

简要总结

Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population.

This study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. In our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.

详细描述

The primary aim of the study is to examine the effects of upper extremity exercises on joint range of motion, grip strength, activity performance and functionality in patients with scleroderma, and thus contribute to the standardization of exercise protocols for the upper extremity in patients with scleroderma. The secondary aim of the study is to ensure the independence of scleroderma patients in their daily living activities and to increase their quality of life.

At least 46 scleroderma patients meeting the inclusion criteria will be included in the study. Demographic information form, Canadian Activity Performance Measurement (COPM), Arm, Shoulder and Hand Problems Questionnaire (DASH), Chronic Rheumatological Influence of the Hands Assessment and Measurement Score Questionnaire (SACRAH), Duruöz Hand Index (DHI) will be applied to the patients, upper extremity joint range of motion will be applied, gross and fine grip strength measurements will be made.

After the initial evaluation, patients will be randomized to intervention and control groups. Upper extremity home exercises including stretching and strengthening will be taught to the intervention group, and they will be asked to do it 5 days a week for 8 weeks. For eight weeks, the patients will be supported by the phone by the physiotherapist and it will be checked whether they do the exercises. The control group will be trained on the principles of joint protection. At the end of eight weeks, patients will have their final evaluation and analysis.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of SSc according to 2013 ACR/EULAR criteria
  • Having upper extremity/hand involvement
  • Voluntary and consent to participate in the study

排除标准

  • Having a known diagnosis of additional rheumatological disease
  • Diagnosis of any known non-rheumatic disease
  • Existence of deformity that prevents doing the exercises
  • Presence of active digital ulcer Being involved in another rehabilitation program
  • Having cognitive disorder
  • Failure to give consent to participate in the study

结局指标

主要结局

Activity Performance

时间窗: 8 weeks

Canadian Activity Performance Measure (Canadian Occupational Performance Measure=COPM/COPM): COPM is a standard measurement tool used to identify an individual's activity performance problems and measure performance satisfaction. COPM is administered as a semi-structured interview. The patient is asked to identify, discuss and rank certain activities that cause him or her difficulty. The five most important issues (as chosen by the patient) are recorded and the patient is asked to indicate their perception of how well they are currently performing the task and to rate how satisfied they are with this level of performance on a scale of 1 to 10 (1-5 not able to / not at all satisfied). not staying and being able to do it very well / extremely satisfied). Performance (COPM-P) and satisfaction (COPM-S) scores are summed separately and divided by five (number of problem areas). This gives average performance and satisfaction scores.

Grip strength

时间窗: 8 weeks

Gross grip strength will be measured with a hand dynamometer (Jamar) 3 times for both hands while the patient is sitting with the elbows bent at 90 degrees near the body and the average will be taken. Fine grip strength will be measured and recorded with a pinchmeter as lateral, triple and fingertip.

次要结局

  • Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH(8 weeks)
  • Disabilities of Arm, Shoulder and Hand questionnaire:(8 weeks)
  • Range of Motion(8 weeks)
  • Duruöz Hand Index (Duruöz Hand Index=DHI/DEI)(8 weeks)

研究者

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

Sebahat Yaprak Cetin,PT

Principal Investigators

Pamukkale University

研究点 (2)

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