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临床试验/NCT07715526
NCT07715526已完成不适用

Comparıson Of The Effects Of Vırtual Realıty-Based Walkıng Exercıse And Treadmıll Exercıse On Balance, Fear Of Fallıng, Motor And Respıratory Functıons, And Fatıgue In Patıents Wıth Chronıc Stroke

Istinye University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2026年3月15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
26
试验地点
1
主要终点
Respiratory Outcome Measures - Volume (L)

研究概览

简要总结

The aim of this study is to compare the effects of virtual reality-based walking exercises and treadmill walking exercises on balance, fear of falling, motor function, respiratory function, and fatigue in individuals who have had a stroke.

The main questions it aims to answer are:

How do virtual reality-based gait exercises and treadmill exercises affect balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke? H0: There is no statistically significant difference between virtual reality-based gait exercises and treadmill exercises in terms of their effects on balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke.

H1: There is a statistically significant difference between virtual reality-based gait exercises and treadmill exercises in terms of their effects on balance, fear of falling, motor and respiratory functions, and fatigue in patients with chronic stroke.

详细描述

This research will be conducted to determine the degree of difference between virtual reality-based walking exercises and treadmill walking exercises in individuals who have had a stroke, when comparing their effects on balance, fear of falling, motor function, respiratory function, and fatigue.

In this study, the data collection process will begin after participants sign a voluntary consent form. Following consent, a structured sociodemographic data form will be completed using face-to-face interviews to determine the sociodemographic characteristics of the participants. This form will record information such as gender, age, height, and weight.

The Mini Mental State Test will be used to assess eligibility for inclusion in the study. The Mini Mental State Test is a widely used, quick, and standardized measurement tool for assessing individuals' cognitive levels. The test covers different cognitive domains such as attention, memory, orientation, compliance with verbal and written instructions, copying complex shapes, and spontaneous sentence writing. The highest possible score on the test is 30, and cognitive levels are classified as low, medium, or high based on the scores obtained. The Turkish adaptation of the test will be used in this study.

Participants' respiratory functions will be assessed using a spirometer and a Pulmonary Function Test. Measurements will be administered before and after treatment, both assessment times, by the same researcher. Tests will be conducted in accordance with internationally accepted criteria for admissibility and reproducibility, and the test will be repeated until at least three valid results are obtained for each measurement. Individual characteristics of participants, such as age, gender, height, and body weight, will be considered in the evaluation of measurement results. Respiratory parameters to be recorded will include: forced expiratory volume in the first second, forced vital capacity, the ratio between these two parameters, peak expiratory flow, mid-expiratory flow rate, maximum voluntary ventilation, and vital capacity values.

To assess respiratory muscle strength, maximum inspiratory pressure and maximum expiratory pressure measurements will be taken using an intraoral pressure measuring device. Measurements will be performed according to a standard measurement protocol. During maximum inspiratory pressure measurement, the participant will be in an upright seated position, a nasal clip will be used to prevent air passage through the nose, and the mouthpiece will be positioned to prevent air leakage. The participant will be asked to perform a maximum inspiration lasting at least 1.5 seconds after maximum expiration. The measurement will be repeated three times, and the highest value obtained will be recorded. Results will be expressed in centimeters of water pressure.

研究设计

研究类型
Interventional
分配方式
Non 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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic stroke patients with hemiparesis (stroke >6 months post-stroke).
  • No visual, auditory, or communication problems.
  • No additional neurological, cardiovascular, orthopedic, etc. conditions causing balance problems. Mini-Mental State Assessment (MMSE) score ≥24
  • Functional Ambulation Classification (FAS) level 4-5
  • Impaired pulmonary function (FEV1/FVC <70% with spirometry)
  • Providing informed consent and being a volunteer
  • Speaking and understanding Turkish.

排除标准

  • Peripheral occlusive arterial disease
  • Uncontrolled hypertension (≥190/110 mmHg)
  • History of epilepsy
  • Inability to respond to visual and sensory stimuli
  • Orthopedic problems restricting movement in the lower extremities
  • Having undergone any botulinum toxin application or surgery within the last 6 months
  • Having neglect syndrome or speech disorders
  • Vestibular system problems or use of medications that may affect the vestibular system

结局指标

主要结局

Respiratory Outcome Measures - Volume (L)

时间窗: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

Respiratory parameters will be assessed at baseline and Week 6 using a COSMED PONY spirometer, with the best of three acceptable attempts recorded for each measure. The primary spirometric outcomes in this category include FEV1 (L), FVC (L), and VC (L).

Respiratory Outcome Measures - Ratio (%)

时间窗: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

The FEV1/FVC ratio (%) will be recorded as a separate spirometric outcome.

Respiratory Outcome Measures - Flow Rate (L/min)

时间窗: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

Peak expiratory flow (PEF) and maximum voluntary ventilation (MVV) will be measured in L/min.

Respiratory Outcome Measures - Flow Rate (L/s)

时间窗: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

Forced expiratory flow at 25-75% of the pulmonary volume (FEF 25-75%) will be measured in L/s.

Respiratory Outcome Measures - Pressure (cmH₂O)

时间窗: FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT

Maximum inspiratory and expiratory pressures (MIP and MEP) will be measured using a pressure manometer with a nasal clip, with the highest of three attempts recorded in cmH₂O.

次要结局

  • EVALUATION OF MOTOR FUNCTIONS(FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT)
  • ASSESSMENT OF FEAR OF FALLING(FROM REGISTRATION TO THE END OF 6 WEEKS OF TREATMENT)
  • ASSESSMENT OF FUNCTIONAL INDEPENDENCE(UNTIL THE END OF 6 WEEKS OF TREATMENT)
  • EVALUATION OF FUNCTIONAL AMBULATION(UNTIL THE END OF 6 WEEKS OF TREATMENT)
  • ASSESSMENT OF FUNCTIONAL CAPACITY(UNTIL THE END OF 6 WEEKS OF TREATMENT)
  • ASSESSMENT OF FATIGUE(UNTIL THE END OF 6 WEEKS OF TREATMENT)

研究者

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

Gökay Küçükyılmaz

BSc

Istinye University

研究点 (1)

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