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临床试验/NCT06385574
NCT06385574招募中不适用

The Effects of Technological Based Rehabilitation on Individuals With Rheumatic Disease With Hand Involvement

Akdeniz University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Hand grip strength measurement

研究概览

简要总结

Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life.

详细描述

In the study, 45 adult individuals diagnosed with rheumatic disease with hand involvement will be randomly divided into 3 groups. The first group will be given virtual reality exercises via Leap Motion Controller. Virtual reality exercises will be applied 30 minutes a day, 3 days a week for 8 weeks. To the second group, a conventional hand rehabilitation program will be applied under the supervision of a physiotherapist. The hand rehabilitation program will be applied 30 minutes a day, 3 days a week for 8 weeks. The third group will be the control group, which continues with its routine medications and is not included in any exercise program. After randomization, the individuals' joint range of motion, gross and fine grip strength, functionality, and disease activities will be evaluated. Evaluations will be made twice, at the beginning and at the end of the 8-week program. Disease Activity Score 28 (DAS 28), hand dynamometer, picnometer, Jebsen Hand Function Test, Nine Hole Peg Test, Duruoz Hand Index and Michigan Hand Outcome questionnairre will be used for evaluation.

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 (Investigator, Outcomes Assessor)

盲法说明

Investigator and outcome assessors do not know which patient is in which group.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Having been diagnosed with a rheumatic disease that meets the latest criteria by a rheumatologist
  • •Involvement in hand joints (pain, swelling, tenderness)
  • •Being 18 years or older
  • •Being on stable drug treatment for the last 6 months
  • •Having sufficient cooperation to participate in the study
  • •Volunteering to participate in the study

排除标准

  • •Not volunteering to participate in the study
  • •Having difficulty in cooperating at work
  • •Having an additional orthopedic and/or neurological disease that will affect hand functions

研究组 & 干预措施

Conventional exercise group

Experimental

Hand exercises (wrist flexion, extension and deviations)) will be applied to individuals in this group under the supervision of a specialist physiotherapist for 45 minutes, 2 days a week for 8 weeks.

干预措施: Virtual reality therapy (Other)

Control group

No Intervention

This group is waiting list. After the study, patients will do hand exercises with the leap motion controller device.

Virtual reality therapy group

Experimental

Individuals in this group will be given hand exercises (wrist flexion, extension and deviations) for 45 minutes, 2 days a week for 8 weeks, using a leap motion control device and games selected in accordance with this device.

干预措施: Virtual reality therapy (Other)

结局指标

主要结局

Hand grip strength measurement

时间窗: 8 weeks

Hand grip strength will be measured with a Jamar hydraulic hand dynamometer. Grip tests will be performed in the standard position recommended by the American Association of Hand Therapists. This is the standard position; The patient will be seated in a position that provides 90-20 degree flexion of the hip and knee, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation. The measurement will be repeated three times. There will be a 15-second rest break at the end of each measurement. As a result, the average of three measurements will be recorded.

Jebsen Hand Function Test (JHFT)

时间窗: 8 weeks

This test consists of tasks involving grasping types commonly used in daily living activities and evaluates people's speed in these tasks. Each stage of the Jebsen Taylor Hand Function Test, which consists of seven sub-steps, will be explained to the individuals in detail before the task and the individuals will be asked to try the task. Estimated time to complete 7 subtasks is 20 minutes. Individuals will complete tasks with both their dominant and non-dominant hands. The task will start with the practitioner's "start" command, and when the task is completed, the test performance will be recorded separately for the tested hand as the time to complete the task. Below is the tasks. Task 1: Stack 4 checkers, Task 2: Card flipping, Task 3: Collecting objects, Task 4: Writing,Task 5: Eating, Task 6: Moving Light Objects, Task 7: Moving Heavy Objects

Duruoz Hand Index (DHI)

时间窗: 8 weeks

The test consists of 18 questions. It is a simple, useful and reliable test that is presented by separating daily life functions (kitchen, clothing, cleaning, workplace and other daily life activities), does not require additional training and equipment for the test, and takes approximately 2-3 minutes to apply. It is a simple and understandable test in which questions are answered according to a Likert scale, with a minimum score of 0 and a maximum of 90 points. A lower score indicates a better functional state.

Nine Hole Peg Test (NHPT)

时间窗: 8 weeks

This device is a device consisting of a square platform and a storage box. There are 9 holes in the square-shaped area (12.7x2cm) and 9 cylinders suitable for these holes. The diameter of the holes is 0.71 cm, the diameter of the cylinders is 0.64 cm, the length is 3.2 cm, the distance between the holes is 3.2 cm, the hole depth is 1.3 cm and the size of the storage box is 13x13 cm. During the test, the patient sits at the table with the 9-hole board, and the patient is asked to quickly take the 9 cylinders from the storage box, place them in the holes in random order, and quickly remove them from the holes without taking a break and place them in the storage box. Meanwhile, time is measured in seconds with a stopwatch. The test is performed 2 times consecutively for both hands and the average of the result is taken. The total test score is calculated by taking the average of the scores for both hands.

Michigan Hand Outcome questionnaire (MHQ)

时间窗: 8 weeks

This questionnaire is a scale consisting of six sections and 57 different items. It helps us question how well patients perform tasks they frequently perform. The patient answers the questions according to the Likert measurement method, which gives values from one to five. Each of the 6 different categories in the scale is scored uniquely. High scores indicate good functionality.

次要结局

  • Hand fine grip strength measurement(8 weeks)
  • Disease Activity Score 28 (DAS 28)(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 Investigator

Akdeniz University

研究点 (1)

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