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临床试验/NCT05796843
NCT05796843已完成不适用

360 Degrees Virtual Reality-based Mirror Therapy for Upper Extremity Rehabilitation Among Stroke Patients

Sahmyook University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年4月1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
45
试验地点
2
主要终点
Fugl-Meyer Assessment for upper extremity (FMA-UE)

研究概览

简要总结

The goal of this randomized controlled trial is to compare the effects of 360 degree virtual reality-based mirror therapy (360MT) to traditional mirror therapy (TMT) and conventional physical therapy (control group) on upper extremity function among stroke patients.

The main questions it aims to answer are:

  • Would 360MT be more effective when treated for 4 weeks in outcome measure ments including: Fugl-Meyer Assessment for upper extremity (FMA-UE); manual function test (MFT); and box & block test (BBT)?
  • How would particants' experience be in terms of satisfactory and enjoyment during 360MT?

The study will have three groups of participants who will be involved in different tasks:

  • 360MT group: will receive mirror therapy using a virtual reality device (HMD) and perform tasks with their paralyzed hand. Sessions will last 30 minutes, 3 times a week for 4 weeks.
  • TMT group: will receive mirror therapy using an acrylic mirror and perform finger, wrist, elbow exercises using their paralyzed limb. Sessions will last 30 minutes, 3 times a week for 4 weeks.
  • Control group: will receive conventional physical therapy consisting of exercises for the upper extremity, 60 minutes per day, 5 sessions a week, for 4 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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • who have not passed 12 months since onset;
  • who can understand and follow instructions;
  • who have ≥21 scores in Korean version of Mini-Mental State Examination (MMSE-K);
  • who have mild to moderate motor impairment according to the Fugl Meyer Assessment (FMA) scores

排除标准

  • patients who have any kinds of mental disorder and/or Alzheimer's disease;
  • who have orthopedic and/or musculoskeletal injury;
  • who have apraxia; and
  • who have previous experiences of participating in investigations and/or mirror therapy.

结局指标

主要结局

Fugl-Meyer Assessment for upper extremity (FMA-UE)

时间窗: Changes from baseline after 4 weeks of intervention

The test is one of the most frequently used evaluation tools that quantitatively assesses recovery after stroke by measuring motor skills, balance ability, sensory function, and range of motion. The maximum total score for FMA-UE is 66 points, containing 18 items to evaluate shoulder, elbow, and forearm; 5 for the wrist; 7 for the hand; and 3 items for coordination.

次要结局

  • Box & Block Test (BBT)(Changes from baseline after 4 weeks of intervention)
  • Manual Function Test (MFT)(Changes from baseline after 4 weeks of intervention)

研究者

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

Sungbae Jo

Physical Therapist

Sahmyook University

研究点 (2)

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