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临床试验/CTRI/2024/07/070644
CTRI/2024/07/070644尚未招募3 期

Effect of exergaming with active passive trainer on lower extremity functions in patients with stroke: A pilot randomized controlled trial

MGM Institute of Physiotherapy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Lower extremity functions

研究概览

简要总结

Patients with stoke will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be explained. Demographic data will be noted. Patients will be screened according to inclusion and exclusion criteria and eligible participants will be included in the study. Before collection of the data, patients will be explained about the study aim and procedure in detail and informed written consent will be obtained from the patients. The participants will be interviewed and the information will be gathered about their demographic data, health related information like past medical history, duration since stroke, investigations. The Pre assessment data will be obtained using Fugl-Meyer scale for lower limb, Time up and go test, 6-minute walk test and functional independence scale. Participants will divide into two groups intervention group and control group using a computer generated numbers. The intervention will be given for 5 days/ week for 6 weeks(21,29). The intervention will include a 20-45minute exergaming session with active passive trainer, followed by a conventional therapy session. In this study, we will utilize an Active Passive Trainer (Kinetic Kinevia) in conjunction with a laptop running the Zwift application. The Zwift application, preinstalled on the laptop, offers a user-friendly interface allowing navigation through various virtual worlds such as Watopia, a fictional island, and customization of avatars. Zwift tracks various performance metrics, such as distance, speed, and power output, allowing patients to monitor their progress over time and set goals for improvement. Experience points are earned by completing rides, races, or other activities in Zwift. As users accumulate XP, they level up and unlock new virtual items, routes, and challenges. Leveling up can also provide access to advanced training plans and workouts. Experience points are earned by completing rides, workouts, races, or other activities in Zwift.  Speed sensors will be affixed to the patient’s paretic limb using a strap, establishing wireless communication with the Zwift application on the laptop through Bluetooth connectivity. These sensors will detect movement patterns as the patient pedals, facilitating the synchronization of the avatar’s speed within the virtual environment to correspond with the patient’s pedaling speed. This alignment of the avatar’s speed and the patient’s actual pedaling motion will significantly enhance the immersive experience, fostering improved concentration and engagement during training sessions. Data collection will be done before 1st week of intervention and at the end of 6thweek of intervention. Data will be entered in Microsoft Excel analyzed using SPSS (Statistical Package for Social Science) version 27.0 and graph pad prism 7.0 version. The data will be represented in the form of visual impression like line diagram, bar diagram and statistical analysis will be done .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients who are diagnosed with stroke from 1 month to 1 year 2.Both male and female.
  • 3.Patients with the first episode of stroke.
  • 4.Mini-Mental State Examination Score more than 24 5.Brunnstrom motion recovery stage of 4 or greater.

排除标准

  • 1.Vision defects such as Blindness and visual field defects.
  • 2.Hearing impairments such as deafness 3.Cardiovascular diseases such as unstable heart diseases 4.Musculoskeletal problems such as severe arthritis and fracture 5.Other Neurological problems such a History of seizures or epilepsy, Parkinson disease, multiple sclerosis, peripheral neuropathy.

结局指标

主要结局

Lower extremity functions

时间窗: Pre and post intervention period (6 weeks)

次要结局

  • Endurance(Pre and post intervention period (6 weeks))
  • Functional independence(Pre and post intervention period (6 weeks))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Smitesh Patil

MGM Institute of physiotherapy

研究点 (1)

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