Comparison of Virtual Reality-Based Mirror Therapy and Functional Electrical Stimulation-Assisted Cycling for Upper Extremity Rehabilitation After Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment
研究概览
简要总结
This randomized controlled, assessor-blinded study aimed to compare the effects of virtual reality-based mirror therapy (VRBMT) and functional electrical stimulation-assisted cycling (FES-cycling) when combined with conventional rehabilitation on upper extremity recovery in patients with stroke.
Participants with first-ever stroke, unilateral hemiplegia, and upper extremity impairment within six months after stroke onset were randomly assigned to one of three groups: conventional rehabilitation alone, conventional rehabilitation plus VRBMT, or conventional rehabilitation plus FES-cycling.
All participants received a four-week rehabilitation program. Upper extremity motor function, functional independence, use of the affected upper extremity in daily activities, and quality of life were assessed before and after the intervention.
详细描述
Stroke frequently results in upper extremity motor impairment, leading to limitations in activities of daily living and reduced quality of life. Although conventional rehabilitation is the standard approach for improving motor recovery after stroke, technology-assisted rehabilitation methods have been developed to enhance neuroplasticity and functional outcomes.
Virtual reality-based mirror therapy provides visual feedback and aims to stimulate motor relearning mechanisms, whereas functional electrical stimulation-assisted cycling combines repetitive movement with electrically induced muscle activation to support motor recovery.
This randomized controlled, assessor-blinded study was designed to compare the additional effects of these two technology-assisted rehabilitation approaches when combined with conventional rehabilitation in patients with post-stroke upper extremity impairment.
Participants were randomly assigned to three parallel treatment groups. Clinical assessments were performed before and after completion of the rehabilitation program by an assessor blinded to group allocation.
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
Outcome assessments were performed by an experienced physiatrist who was 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
- 否
入选标准
- •Age older than 18 years
- •First-ever stroke
- •Unilateral hemiplegia
- •Time since stroke onset ≤6 months
- •Upper extremity Brunnstrom recovery stage between 1 and 4
- •Modified Ashworth Scale score <3 in the affected upper extremity
- •Ability to maintain sufficient sitting balance
排除标准
- •Visual impairment
- •Contraindication to electrical stimulation, including cardiac pacemaker implantation
- •Cognitive impairment (Mini-Mental State Examination score <25)
- •Severe aphasia preventing completion of clinical assessments
- •Presence of additional neurological disorders, including Parkinson's disease, Alzheimer's disease, multiple sclerosis, neuromuscular junction disorders, motor neuron disease, or peripheral nerve lesions
- •Neglect syndrome
- •Orthopedic conditions affecting upper extremity function, including amputation or joint contracture
- •Severe cardiac disease
- •Uncontrolled hypertension
- •Psychiatric disorders such as schizophrenia or bipolar disorder
- •Pregnancy or suspected pregnancy
- •Acute deep vein thrombosis or thrombophlebitis
- •Local infection at the treatment site
研究组 & 干预措施
Conventional Rehabilitation
Participants received a conventional rehabilitation program consisting of neurophysiological exercises, range of motion exercises, strengthening exercises, stretching exercises, balance and coordination training, and ambulation training for 40 minutes per day, five days per week, for four weeks.
干预措施: Conventional Rehabilitation (Other)
Virtual Reality-Based Mirror Therapy
Participants received conventional rehabilitation combined with virtual reality-based mirror therapy using the Neuroforma system. Virtual reality-based mirror therapy was administered for 15 minutes per day, five days per week, for four weeks.
干预措施: Conventional Rehabilitation (Other)
Virtual Reality-Based Mirror Therapy
Participants received conventional rehabilitation combined with virtual reality-based mirror therapy using the Neuroforma system. Virtual reality-based mirror therapy was administered for 15 minutes per day, five days per week, for four weeks.
干预措施: Virtual Reality-Based Mirror Therapy (Device)
Functional Electrical Stimulation-Assisted Cycling
Participants received conventional rehabilitation combined with functional electrical stimulation-assisted cycling using the RT-300 system. FES-cycling therapy was administered five days per week for four weeks.
干预措施: Conventional Rehabilitation (Other)
Functional Electrical Stimulation-Assisted Cycling
Participants received conventional rehabilitation combined with functional electrical stimulation-assisted cycling using the RT-300 system. FES-cycling therapy was administered five days per week for four weeks.
干预措施: Functional Electrical Stimulation-Assisted Cycling (Device)
结局指标
主要结局
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment
时间窗: Baseline and 4 weeks
Upper extremity motor function was evaluated using the upper extremity section of the Fugl-Meyer Assessment (FMA-UE). The FMA-UE assesses motor impairment of the affected upper extremity, with total scores ranging from 0 to 66. Higher scores indicate better upper extremity motor function. Change from baseline to the post-treatment assessment was calculated as the post-treatment score minus the baseline score.
次要结局
未报告次要终点
研究者
Ezgi Aydın
Assistant Professor of Physical Medicine and Rehabilitation
Ankara City Hospital Bilkent