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临床试验/NCT06128187
NCT06128187Unknown不适用

The Effect of Dual Task Training With Virtual Reality on Upper Extremity Functions and Cognitive Functions in Stroke Patients

Muş Alparslan University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Box and Block test (BTT)

研究概览

简要总结

Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients. Our aim is to determine the effectiveness of dual-task upper extremity training compared to single-task training.

详细描述

Purpose: To investigate the effect of upper extremity single and double task training using virtual reality on upper extremity functions, cognitive functions and dual task performance in stroke patients.

Materials and Methods: The study was planned on patients who applied to Erenkoy Physical Therapy and Rehabilitation Hospital and were diagnosed with hemiplegia by a specialist neurologist. Participants who met the inclusion criteria in the study will be divided into two groups as Group 1 = study group and group = 2 control groups by computerized randomization method. For the evaluation of upper extremity functions of the participants whose socio-demographic characteristics were recorded; Fugl Mayer Upper Extremity Assessment Scale, Box and Blocks Test (BBT), Stroop Test and Montreal Cognitive Assessment Scale (MOCA) will be used to evaluate cognitive functions. The Barthel index of daily living activities of the patients and the Stroke-Specific Quality of Life Assessment Scale will be used to evaluate the health-related quality of life. Evaluation of double-task performance will be evaluated by the Box and Blocks Test (BBT) and a cognitive task added to the Xbox 360 Kinect game apps. Participants will be evaluated 4 times before the treatment, after the treatment and at the 1st month and 3rd month after the treatment in order to see the sustainability of the effect of the rehabilitation program.

Patients in both groups will receive a conventional upper extremity rehabilitation program (neurophysiological methods, joint range of motion exercises, strengthening exercises, occupational therapy) and 30 minutes of virtual reality training for 6 weeks, 5 days a week, for 45 minutes daily. Participants in the study group will be given double-task training in addition to stroke rehabilitation and virtual reality training. Dual task training will be performed with the addition of cognitive tasks in addition to virtual reality training.

Cognitive Tasks;

  1. Attention-oriented, e.g. Counting numbers: Counting numbers backwards three by three from the participant rhythmically,
  2. For memory, e.g. describing activities of daily living: Describing an event from the participant in detail,
  3. For executive functions, e.g. Verbal communication: It will be planned in the form of giving the participant a letter from the alphabet and asking for words in certain categories such as plants, animals and countries. As progress is made, the difficulty of the missions will increase.

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)

盲法说明

Participants were enrolled in treatment without being aware of differences in treatment between groups

入排标准

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

入选标准

  • •Patients who are diagnosed with hemiplegia for the first time
  • •Patients aged ≥18 years
  • •Medically stable
  • •According to Brunnstrom stages, the upper extremity is at stage 3 and above
  • •Must have the ability to understand, hear and speak sufficiently to perform treatment with a game console.
  • •Montreal Cognitive Assessment (MoCA) score ≥ 21
  • •Patients who are literate

排除标准

  • •Presence of high blood pressure, heart disease, vision problems
  • •Those with risk of shoulder subluxation and fracture
  • •Hemiplegic side, with joint movement limitation in the upper extremity Having a history of epileptic seizures

研究组 & 干预措施

Control Group

Active Comparator

Participants will undergo a conventional upper extremity rehabilitation program for 45 minutes daily, 5 days a week, for 6 weeks. After the conventional rehabilitation program, 30 minutes of virtual reality training for the upper extremity will be applied.

干预措施: Control Group (Other)

Study Group

Active Comparator

Participants will undergo a conventional upper extremity rehabilitation program for 45 minutes a day, 5 days a week, for 6 weeks. In addition to the conventional rehabilitation program, dual-task training will be provided with a 30-minute virtual reality training program. Cognitive tasks will be given in addition to virtual reality training as dual-task training.

干预措施: Study Group (Other)

结局指标

主要结局

Box and Block test (BTT)

时间窗: 18 weeks

Box and Block test (BBT) was used to measure unilateral gross manual dexterity. This test consists of moving, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60seconds. The patients had number of blocks moved within 60seconds was recorded. The higher number of blocks moved, the higher score you get.

次要结局

  • Stroke Specific Quality Of Life scale (SS-QOL)(18 weeks)
  • Barthel index(18 weeks)
  • Montreal Cognitive Assessment (MoCA)(18 weeks)
  • Fugl-Meyer Assessment (FMA-UL)(18 weeks)
  • oktem SBST(18 weeks)
  • stroop test(18 weeks)
  • Digit Span Test (DST)(18 weeks)

研究者

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

Ramazan Öztürk

physiotherapist

Marmara University

研究点 (2)

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