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临床试验/NCT03689660
NCT03689660Unknown不适用

The Feasibility of Virtual Reality in Children With Neuromuscular Disease and the Effectiveness of Virtual Reality and Biofeedback Training on Functional Levels of Children With Neuromuscular Disease

Merve Kurt2 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2019年2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
24
试验地点
2
主要终点
The Motor Function Measure-32

研究概览

简要总结

Our study is a randomized controlled study and the subjects included in the study will be divided into three groups as virtual reality training, biofeedback training, and conventional rehabilitation.

详细描述

We have 3 purposes:

  1. Determine the feasibility of virtual reality training in children with neuromuscular disease.
  2. To determine the effect of virtual reality, biofeedback training, and conventional rehabilitation on functional levels and balances of children with neuromuscular disease.
  3. To compare the motivation of children with neuromuscular disease to virtual reality, biofeedback training, and conventional rehabilitation.

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

Nope

入排标准

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

入选标准

  • Volunteer to participate in the study
  • Being diagnosed with the neuromuscular disease
  • No other systemic or neurological disease
  • No significant visual or auditory loss
  • Continuation of ambulation (10 m walking independently)
  • Be able to understand simple commands

排除标准

  • Performing a drug change at 3 months before treatment or during treatment which may affect muscle strength
  • Acute inflammation in the musculoskeletal system
  • Finding any orthopedic problem that prevents activities during the research

结局指标

主要结局

The Motor Function Measure-32

时间窗: 30 minutes

MFM-32 is a scale developed to evaluate motor functions of children and adults with neuromuscular disease. The scale can be used to evaluate both in children with and without walking problems.The MFM-32 consists of 32 items. Each item is answered with a 4-point likert scale (0 = cannot initiate the exercise or maintain its starting position, 1 = partially completes the exercise, 2 = completes exercises with compensations, slowly or roughly, 3 = completes the exercise in the standard pattern). The scale can be used for the evaluation of individuals aged between 6 and 60 years.

Feasibility of Virtual Reality

时间窗: 1 Minutes

The feasibility of virtual reality will be examined by laboratory tests. Laboratory tests to be carried out are as follows: Creatine Kinase, Lactate Dehydrogenase (LDH), Myoglobin, Serum Electrolytes, C-Reactive Protein levels. These are agents that are indicative of muscle destruction or inflammation. Will be evaluated in order to follow muscle destruction.

Pediatric Functional Independence Measure

时间窗: 5 minutes

WeeFIM consists of 18 items divided into 6 sub-scales (self-care, sphincter control, mobility, locomotion, communication, social communication). Each item is scored from 1 to 7. A higher score indicates a better functional level.

Balance Master System

时间窗: 20 minutes

The static and dynamic balance evaluated using the Balance Master System ver. 8.1. (NeuroCom International Inc. Clackamas, OR, USA) force platform system which has multiple testing protocols designed to examine balance. The system includes a computer linked force plate that records data with the aid of crystal transducers.

Vignos Scale

时间窗: 2 Minutes

The Vignos Scale has been developed to evaluate the lower extremity functions. The scale allows the lower extremity functions to be scored between 1 (can walk and climb stairs without help) and -10 (bed dependent).

Pediatric Motivation Scale

时间窗: 5 Minutes

The PMOT is recommended for assessing motivation to rehabilitation program in children aged 8 to 18 years. It comprises six subscales (effort-importance, interest-enjoyment, competence, relatedness, autonomy, and value-usefulness) with total 21 items. While the 19 items of the scale are answered with a 6-point smiley face scale (1 = absolutely false, 6 = absolutely correct), there are 2 open-ended questions on the scale. The high scores in each sub-scales indicate that the child's motivation in that sub-section is high. A higher total score indicates that the motivation is intrinsically arranged and that the child has a high motivation. From this point of view, the scale gives information about both the type of motivation and the amount of motivation of the child.

Visual Analog Scale

时间窗: 1 Minute

Visual Analog Scale will be applied to evaluate muscle pain. It has a fixed line between two end adjectives of 100 mm length. The end adjectives in our study will be "no pain" and "too much pain".

次要结局

  • Fall Frequency(1 Minute)
  • Stand Up from Supine Position Test(1 Minutes)
  • Stair Climb Test(2 Minutes)
  • Pediatric Functional Reaching Test(1 Minute)
  • Muscle Strength Test with Hand Held Dinamometer(20 minutes)
  • Timed Up Go Test(2 Minutes)
  • T-shirt Wear Remove Test(2 Minutes)

研究者

发起方
Merve Kurt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merve Kurt

Research Assistant

Dokuz Eylul University

研究点 (2)

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