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临床试验/NCT03651479
NCT03651479已完成不适用

The Comparison of Virtual and Real Boxing Training in Hemiparetic Stroke Patients: a Randomized Controlled Study

Eastern Mediterranean University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年11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
40
试验地点
2
主要终点
Wolf Motor Function Test

研究概览

简要总结

The aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.

详细描述

The use of computer systems has become a highly accepted approach in neurorehabilitation currently. Virtual reality (VR) is frequently used in different disease groups for this purpose. By using various VR equipment (sensors, balance board, control, etc.), exercises can be individualized to suit individual needs and aim to stimulate neural plasticity according to motor learning principles with repetitive activities.

In recent years, it has been observed that boxing training (boxing therapy) in individuals with neurological diseases (e.g. Parkinson's disease and stroke) gives positive results. It has been shown in the literature there are short and long-term improvement in daily life activities, quality of life, balance and gait functions after boxing training in patients with Parkinson' disease despite the progressive nature of Parkinson's disease. Additionally it was found that boxing program in sitting has positive effects on upper extremity functions, balance, walking and quality of life in stroke patients. In the literature, there were no studies comparing virtual and boxing therapy in stroke patients. Therefore, the aim of this study is to compare the effects of virtual and real boxing training in addition to neurodevelopmental training (NDT) on cognitive status, upper extremity functions, balance and activities of daily living in hemiparetic stroke patients.

Patients who have had a stroke for the first time with hemiparesis, who are between the ages of 18-70, who has Mini Mental Test score above 23, whose functional level is less than 4 according to the Modified Rankin Scale, who has upper extremity spasticity lower than 3 on Modified Ashworth Scale will be included in this study. In case of hypertension which may prevent rehabilitation, heart disease, subluxation and fracture at the shoulder, visual impairment, limitation in passive normal joint movement in hemiplegic side, botulinum toxin administration or surgical operation in the last 6 months patients will not be excluded.

All the patients will be measured with Addenbrooke's Cognitive Assessment (ACA), Minnesota Hand Skill Test, Wolf Motor Function Test (WMFT), Fullerton Advanced Balance Scale (FAB), Frenchay Activity Index (FAI) and video boxing analysis of punching.The measurements will be made at the beginning of the treatment (0 weeks) and at the end of the treatment (8 weeks).

NDT approaches consist of upper extremity facilitation techniques and activities in accordance with the patient's functional level, weight transfer and walking exercises to increase sitting and standing balance, mat exercises with the same purpose considering the functional level for each patient. In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks. In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with first time ever stroke
  • Patients with hemiparesis
  • Patients who are between the ages of 18-70
  • Patients who has Mini Mental Test score above 23
  • Patients whose functional level is less than 4 according to the Modified Rankin Scale
  • Patients who has upper extremity spasticity lower than 3 on Modified Ashworth Scale

排除标准

  • Hypertension
  • Heart disease
  • Subluxation and fracture at the shoulder
  • Visual impairment
  • Limitation in passive normal joint movement in hemiplegic side
  • Botulinum toxin administration or surgical operation in the last 6 months patients

结局指标

主要结局

Wolf Motor Function Test

时间窗: 8 weeks

Wolf Motor Function Test (WFMT) quantifies upper extremity motor ability through the use of timed and functional tasks. The widely used version of the WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 15 to subject functional ability during various tasks. Performances are scored using a 6-point functional ability scale and the less affected upper extremity followed by the most affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum total score is 75 and minimum is 0. Lower scores indicating lower functional levels.

次要结局

  • Video Boxing Analysis of Punching(8 weeks)
  • Addenbrooke's Cognitive Assessment(8 weeks)
  • Frenchay Activities Index(8 weeks)
  • Minnesota Manual Dexterity Test(8 weeks)
  • Fullerton Advanced Balance Scale(8 weeks)

研究者

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

Gözde İyigün

Faculty member

Eastern Mediterranean University

研究点 (2)

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