Effect of Combining Mirror Therapy With Soft Robotic Glove on Hand Function Recovery in Post-Stroke Hemiplegic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Upper Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)
研究概览
简要总结
Post-stroke hemiplegia frequently results in impaired upper limb function, which significantly affects independence and quality of life. Various rehabilitation approaches have been developed to improve motor recovery, including mirror therapy and robotic-assisted training. Mirror therapy uses visual feedback to stimulate neural plasticity and enhance motor recovery, while soft robotic gloves assist repetitive hand movements and facilitate functional training.
This randomized controlled trial aims to investigate the effect of combining mirror therapy with a soft robotic glove on hand function recovery in patients with post-stroke hemiplegia. Participants will be randomly assigned to different intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation.
The primary outcome will assess improvement in upper limb motor function using validated clinical assessment tools. Secondary outcomes will evaluate functional hand performance and activities of daily living. The findings of this study may contribute to improving rehabilitation strategies for stroke survivors and provide evidence for integrating innovative rehabilitation technologies into clinical practice.
详细描述
Stroke is one of the leading causes of long-term disability worldwide and commonly results in upper limb motor impairment. Recovery of hand function is essential for improving independence in activities of daily living. However, rehabilitation of the affected upper limb remains a major challenge in stroke management.
Mirror therapy is a rehabilitation technique that provides visual feedback by reflecting movements of the unaffected limb in a mirror, creating the illusion that the affected limb is moving normally. This approach is believed to promote cortical reorganization and enhance motor recovery. In recent years, robotic-assisted rehabilitation devices, including soft robotic gloves, have been developed to provide repetitive, task-specific training and facilitate motor relearning.
Soft robotic gloves are wearable assistive devices designed to support hand movements and enable repetitive practice of grasping and releasing tasks. These devices provide controlled assistance during rehabilitation exercises and may enhance the intensity and effectiveness of therapy.
This study is designed as a randomized controlled trial to evaluate the effectiveness of combining mirror therapy with soft robotic glove training in improving hand function among patients with post-stroke hemiplegia. Eligible participants will be randomly assigned to intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation.
The intervention program will be delivered over a structured rehabilitation period, and clinical assessments will be conducted at baseline and after completion of the intervention. Outcome measures will focus on upper limb motor recovery, hand function performance, and functional independence.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-70 years with first-ever ischemic or hemorrhagic stroke confirmed by imaging (CT or MRI)
- •Moderate upper limb motor impairment (Fugl-Meyer Assessment Upper Extremity [FMA-UE] score 20-50)
- •Ability to follow simple instructions (Six-Item Cognitive Impairment Test, 6CIT)
- •Ability to sit independently for at least 30 minutes
- •Medically stable and cleared to participate in rehabilitation interventions
- •Willingness to provide informed consent and adhere to the study protocol
排除标准
- •Severe upper limb spasticity (Modified Ashworth Scale ≥ 3)
- •Cognitive or psychiatric disorders interfering with participation
- •Other neurological or musculoskeletal conditions affecting upper limb function (e.g., Parkinson's disease, multiple sclerosis, fractures)
- •Prior exposure to intensive Mirror Therapy or Soft Robotic Gloves
- •Visual impairment that cannot be corrected with glasses or contact lenses
- •Uncontrolled cardiovascular or other medical conditions that would prevent safe participation
研究组 & 干预措施
Conventional Rehabilitation
Participants receive conventional upper limb rehabilitation therapy according to standard clinical practice for stroke rehabilitation
干预措施: Conventional Rehabilitation (Other)
Mirror Therapy
Participants receive mirror therapy sessions designed to improve motor function of the affected upper limb following stroke.
干预措施: Mirror Therapy (Other)
Soft Robotic Glove Training
Participants perform upper limb training using a soft robotic glove device to assist hand movement and improve motor recovery after stroke.
干预措施: Soft Robotic Glove (Device)
Mirror Therapy plus Soft Robotic Glove
Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training to enhance upper limb motor recovery after stroke.
干预措施: Mirror Therapy plus Soft Robotic Glove (Combination Product)
结局指标
主要结局
Upper Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE)
时间窗: Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up.
Assesses motor recovery of the affected upper limb following stroke, including voluntary movement, coordination, and reflex activity using a standardized stroke-specific motor scale. Scores range from 0 to 66, with higher scores indicating better motor recovery and motor performance.
Functional Use of Affected Limb (Functional Test of Upper Limb Hemiplegia - Hong Kong, FTHUE-HK)
时间窗: Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up
Evaluates functional use of the affected upper limb in individuals with hemiplegia through hierarchical task performance. Scores range from Level 1 (no active movement) to Level 7 (advanced functional hand use), with higher levels indicating greater functional recovery.
次要结局
未报告次要终点
研究者
Mohammed Hindi Jaryan
PhD Candidate
University of Baghdad