The Impact of Virtual Reality Games on Upper Extremity Function, Activity, and Participation in Hemiplegic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fugl-Meyer assessment for upper extremity
研究概览
简要总结
This study aims to evaluate the effectiveness of Leap Motion-supported virtual reality therapy, applied in addition to traditional rehabilitation programs, in individuals who develop hemiplegia after a cerebrovascular accident. The study will examine the effects of this additional therapy on upper extremity functions, activities of daily living, and participation levels.
详细描述
Hemiplegic patients experience significant limitations in their activities of daily living (ADL) and participation levels due to marked losses in upper extremity function following stroke. Approximately 80% of individuals who have had a stroke experience impairment in upper extremity function, and because the upper extremity plays a critical role in many motor functions, these impairments significantly affect independence. Therefore, initiating upper extremity rehabilitation early and tailoring it to the individual's needs is of great importance for functional improvement. Various treatment methods are used in stroke rehabilitation to support physical, functional, and psychological recovery.
In recent years, virtual reality-based technologies have been increasingly used in rehabilitation processes due to their ability to increase motivation, enable intensive and repetitive motor training, and provide environmental feedback. Leap Motion-based virtual reality applications enable patients to participate in therapy through safe, interactive, and task-oriented activities by allowing three-dimensional perception of upper extremity movements.
The aim of this study is to compare the effects of Leap Motion-based virtual reality rehabilitation, applied in addition to conventional treatment, on the functional development of the plegic upper extremity, activities of daily living, and participation levels compared to the group receiving conventional treatment alone.
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
- Single (Outcomes Assessor)
盲法说明
The study was conducted in a single-blind manner, only the evaluator did not know which patient was in the experimental group and which patient was in the control group. Due to the nature of the treatment, the patients and the occupational therapist performing the game were not blinded.
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 must be above eighteen years of age
- •Have had a first-time stroke
- •Be within twelve months of stroke
- •Have a Brunnstrom score of four or more for the upper extremity
- •Be cognitively adequate (scoring ≥23 on the mini-mental test scale)
排除标准
- •Being in the unstable phase of the disease
- •Visual and/or auditory impairments
- •Unilateral spatial neglect (hemineglect)
- •Modified Ashworth Scale score of ≥3 in the affected upper limb
- •Had a history of botulinum toxin A (Botox) injection in the affected upper limb within the previous six months
- •Other systemic neuromuscular disorders (exc; Alzheimer Disease, Parkinson Disease, Multipl Sclerosis...)
- •Have cerebellar involvement characterised by dysmetria, dysdiadochokinesia or ataxia
- •Have a prior orthopaedic or neuromuscular injuries affecting both upper limbs
- •Have impaired static sitting balance
研究组 & 干预措施
control group
The control group received conventional rehabilitation for 1 hour every day, 5 days a week for 4 weeks.
干预措施: conventional rehabilitation (Other)
experimental group
In addition to conventional rehabilitation, participants in the experimental group received Leap Motion-based virtual reality therapy 5 days per week for 4 weeks. For this purpose, the Leap Motion device, leased from Becure GmbH (GOSB Teknopark Hightech Building, Gebze, Kocaeli, Turkey), was used to deliver a computer-based HandROM program designed to improve upper extremity functions. Each session consisted of 4 games, played for 10 minutes each, resulting in a total of 40 minutes of additional upper extremity exercise per day. Four therapeutic games used in intervention are as follows: Leap Maze, Leap Ball , Pong and CatchAPet. During the games, patients performed forearm pronation-supination, wrist flexion-extension, and finger flexion-extension movements.
干预措施: leap motion based virtual reality rehabilitation (Device)
experimental group
In addition to conventional rehabilitation, participants in the experimental group received Leap Motion-based virtual reality therapy 5 days per week for 4 weeks. For this purpose, the Leap Motion device, leased from Becure GmbH (GOSB Teknopark Hightech Building, Gebze, Kocaeli, Turkey), was used to deliver a computer-based HandROM program designed to improve upper extremity functions. Each session consisted of 4 games, played for 10 minutes each, resulting in a total of 40 minutes of additional upper extremity exercise per day. Four therapeutic games used in intervention are as follows: Leap Maze, Leap Ball , Pong and CatchAPet. During the games, patients performed forearm pronation-supination, wrist flexion-extension, and finger flexion-extension movements.
干预措施: conventional rehabilitation (Other)
结局指标
主要结局
Fugl-Meyer assessment for upper extremity
时间窗: baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3)
In our study, we used the upper extremity motor evaluation part of the Fugl-Meyer scale. This scale is valid and reliable in evaluating motor recovery after stroke. This scale has 4 subheadings: arm evaluation (maximum 36 points), wrist evaluation (10 points), hand evaluation (maximum 14 points), coordination and speed (maximum 6 points). It consists of 33 items scored from 0 to 2. '0: Cannot realize, 1: Partially realizes, 2: Completely realizes'. A maximum of 66 points can be obtained in the upper extremity scoring. Higher scores indicate better motor recovery.
次要结局
- Selective Control of the Upper Extremity Scale(baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3))
- Stroke Specific Quality of Life Scale(baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3))
- Turkish Version of Disabilities of The Arm, Shoulder and Hand(baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3))
- nine hole peg test(baseline (T0), at the end of treatment (T1), one month after treatment completion (T2), and three months after treatment completion (T3))
研究者
Pinar Dogan
Medical doctor
Gaziosmanpasa Research and Education Hospital