跳至主要内容
临床试验/NCT07533734
NCT07533734尚未招募不适用

The Effect of an Augmented Reality-Based Mirror Therapy System on Upper Extremity Motor Recovery and Functional Activity Level in Stroke Patients

Marmara University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Fugl-Meyer Assessment - Upper Extremity

研究概览

简要总结

Objective The aim of this study is to investigate the effects of an augmented reality-based mirror therapy system (MirrARm), developed using sensor-based tracking and visual feedback principles, on upper extremity motor recovery and functional activity levels in patients with stroke.

Research Questions

This study seeks to address the following questions:

Does the MirrARm system improve upper extremity motor recovery and functional activity levels in patients with stroke?

Are the effects of the MirrARm system on upper extremity motor recovery and functional activity levels greater than those of conventional mirror therapy in patients with stroke?

Study Design and Comparison The MirrARm system will be compared with conventional mirror therapy to evaluate its effectiveness in patients with stroke.

Participants and Procedures Participants will take part in a treatment program administered three days per week for a total duration of eight weeks. Outcome measures will be assessed at baseline (Week 0), at mid-intervention (Week 4), and at the end of the intervention period (Week 8).

详细描述

The aim of this study is to develop an augmented reality-based mirror therapy system, MirrARm, based on sensor-based tracking and visual reflection principles, and to investigate its effects on upper extremity motor recovery and functional activity levels in patients with stroke.

In this study, individuals with stroke who meet the inclusion criteria will be randomly assigned into two groups using stratification based on age, sex, and Fugl-Meyer Upper Extremity scores. The groups will be the Augmented Reality-Based Mirror Therapy group (AR-MT) and the Conventional Mirror Therapy group (C-MT). All participants will receive conventional physiotherapy training for 30 minutes per session, three days per week, for eight weeks. Participants in the AR-MT group will additionally receive 30 minutes of exercise training using the MirrARm system three days per week for eight weeks, while participants in the C-MT group will receive exercise training using conventional mirror therapy for the same duration and frequency.

In this study, augmented reality-based mirror therapy training will be delivered using the MirrARm system. The MirrARm system will consist of a 27-inch computer monitor, a Leap Motion Controller motion-tracking sensor, and a laptop computer. The monitor will be placed on a work table and will display images transmitted from the connected laptop computer. The Leap Motion sensor will also be connected to the laptop computer and positioned on the table in front of the monitor. The Leap Motion sensor will be used to transfer participants' hand movements to the screen in real time. Through its software features, the MirrARm system will display movements performed with one hand on the screen as if they were being performed by the opposite hand.

The software infrastructure of the MirrARm system will be developed using the Unity 6.1 game engine. Participants' hand movements will be tracked with high precision in a three-dimensional environment using the official software development kits (SDKs) and libraries of the Leap Motion device. Applications will be designed using ready-made or customized Unity assets positioned within a three-dimensional coordinate system in the Unity environment, and realistic physical interactions will be provided through Unity's NVIDIA PhysX-based physics engine. The operation of the application will be controlled through custom MonoBehaviour-based scripts developed using the C# programming language. These scripts will dynamically manipulate Transform component properties of scene objects, including position, rotation, and scale; process user interactions through event-based triggers; and execute predefined functions within the game loop. Objects requiring physical interaction will be assigned Unity's Rigidbody component to provide physical properties such as mass, gravity, and collision responses, and interaction regions will be defined using Collider components.

During training sessions using the MirrARm system, participants with stroke will be seated in front of the screen on a back-supported chair and will perform the tasks included in gamified therapeutic activities using their unaffected upper limb, while observing these movements on the screen as if they were being performed by the affected upper limb.

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

Separate participant information forms will be prepared for each study group. This approach will ensure that participants are not informed about the intervention applied in the other group.

The researcher responsible for assessing the outcome measures will be blinded to participants' group allocation.

入排标准

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

入选标准

  • First-ever unilateral stroke diagnosed by a specialist physician,
  • Presence of post-stroke hemiplegia,
  • Age ≥ 18 years,
  • Time since stroke between 3 and 12 months,
  • Score ≥ 24 on the Standardized Mini-Mental State Examination,
  • Upper extremity motor score ≤ 22 on the Fugl-Meyer Assessment.

排除标准

  • Inability to sit independently in a supported chair,
  • Insufficient communication ability due to aphasia,
  • Presence of structural and/or acquired impairments limiting active movement of the unaffected upper limb,
  • Presence of visual or visual-perceptual impairments,
  • Presence of unilateral neglect,
  • Presence of neurological, psychiatric, cognitive, or oncological disorders other than stroke.

研究组 & 干预措施

Augmented Reality-Based Mirror Therapy Group

Experimental

Participants in this group will undergo an 8-week training program administered three days per week. Each session will consist of 30 minutes of augmented reality-based mirror therapy exercise training using the MirrARm system developed by the research team, followed by 30 minutes of conventional physiotherapy treatment.

干预措施: Augmented Reality-Based Mirror Therapy (Other)

Augmented Reality-Based Mirror Therapy Group

Experimental

Participants in this group will undergo an 8-week training program administered three days per week. Each session will consist of 30 minutes of augmented reality-based mirror therapy exercise training using the MirrARm system developed by the research team, followed by 30 minutes of conventional physiotherapy treatment.

干预措施: Conventional Physiotherapy Treatment (Other)

Conventional Mirror Therapy Group

Active Comparator

Participants in this group will undergo an 8-week training program administered three days per week. Each session will consist of 30 minutes of exercise training using a mirror box followed by 30 minutes of conventional physiotherapy treatment.

干预措施: Conventional Mirror Therapy (Other)

Conventional Mirror Therapy Group

Active Comparator

Participants in this group will undergo an 8-week training program administered three days per week. Each session will consist of 30 minutes of exercise training using a mirror box followed by 30 minutes of conventional physiotherapy treatment.

干预措施: Conventional Physiotherapy Treatment (Other)

结局指标

主要结局

Fugl-Meyer Assessment - Upper Extremity

时间窗: Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based measure developed in Sweden by Fugl-Meyer and colleagues in 1975 to evaluate motor function, balance, sensation, and joint functioning in individuals after stroke. The upper extremity subscale (FM-UE) is widely regarded as the gold standard for assessing upper limb motor impairment and quantifying motor recovery following stroke.

Wolf Motor Function Test

时间窗: Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

The Wolf Motor Function Test (WMFT) is a standardized assessment developed to evaluate upper extremity motor function in individuals with moderate to severe motor impairment. The test was originally developed by Wolf and colleagues and later modified by Morris and colleagues. The modified version of the WMFT will be used in this study. The WMFT consists of 17 tasks. For 15 tasks, data are collected in two domains: Functional ability and Performance time. The remaining two tasks assess upper extremity muscle strength and will not be included in the present study.

The Chedoke Arm and Hand Activity Inventory-9

时间窗: Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).

The Chedoke Arm and Hand Activity Inventory (CAHAI) is a standardized assessment with detailed administration and scoring guidelines designed to evaluate functional performance of the upper extremity in individuals after stroke. Because the original version is time-consuming to administer, a shortened 9-item version (CAHAI-9) was developed. The CAHAI-9 will be used in this study to assess functional upper limb activity.

次要结局

  • Motor Activity Log-28(Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).)
  • Grip Strength(Assessments will be conducted at three time points: at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验