Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke

Официальное название

Effect of Combining Mirror Therapy With Soft Robotic Glove on Hand Function Recovery in Post-Stroke Hemiplegic Patients: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

The results of this study are expected to provide evidence regarding the effectiveness of integrating mirror therapy with robotic-assisted rehabilitation approaches for improving upper limb recovery after stroke. This may support the development of more effective rehabilitation protocols for patients with post-stroke hemiplegia.

Вмешательства

• Другое Conventional Rehabilitation
  Standard rehabilitation therapy focused on improving upper limb function in individuals with stroke
• Другое Mirror Therapy
  A rehabilitation technique using a mirror to create a visual illusion of movement in the affected limb to improve motor recovery after stroke.
• Устройство Soft Robotic Glove
  A wearable soft robotic glove designed to assist hand movement and facilitate motor recovery in individuals with stroke
• Комбинированный продукт Mirror Therapy plus Soft Robotic Glove
  Participants receive a combined intervention consisting of mirror therapy and soft robotic glove training

Первичные конечные точки

• Upper Limb Motor Function (Fugl-Meyer Assessment for Upper Extremity, FMA-UE) [Срок оценки: Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up.]
• Functional Use of Affected Limb (Functional Test of Upper Limb Hemiplegia - Hong Kong, FTHUE-HK) [Срок оценки: Baseline, 4 weeks during intervention, immediately post-intervention (6 weeks), and 3-month follow-up]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• Rehabilitation and Neurology Outpatient Unit — Baghdad

Публикации

• Ko MJ, Chuang YC, Ou-Yang LJ, Cheng YY, Tsai YL, Lee YC. The Application of Soft Robotic Gloves in Stroke Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2023 Jun 2;13(6):900. doi: 10.3390/brainsci13060900. PMID 37371378
• Qian J, Liang C, Liu R, Yu J, Yang T, Bai D. Combination of robot-assisted glove and mirror therapy improves upper limb motor function in subacute stroke patients: a randomized controlled pilot study. Front Neurol. 2025 Jun 16;16:1602896. doi: 10.3389/fneur.2025.1602896. eCollection 2025. PMID 40589984

Идентификаторы

NCT: NCT07467915 · UOB-MT-SRG-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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