跳至主要内容
临床试验/NCT07435688
NCT07435688已完成不适用

Comparison of The Effectiveness Of Mirror Therapy And Mirror Mode of a Hand Robot in Upper Extremity Motor Recovery After Stroke

Zeynep Lide Uz2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Fugl Meyer Assesment

研究概览

简要总结

The goal of this clinical trial is to compare the effectiveness of conventional mirror therapy and robotic mirror mode training in promoting upper extremity motor recovery in adult patients with ischemic stroke during the early subacute phase. The main questions it aims to answer are:

Does mirror mode of a robotic hand device result in greater motor function recovery compared to conventional mirror therapy?

Are there differences between the groups in somatosensory improvement and gross motor skill outcomes?

Do both intervention modalities result in clinically significant improvements in motor and functional outcomes?

Researchers will compare a conventional mirror therapy group and a robotic-assisted mirror mode group to determine which provides more significant gains in motor function, somatosensory input, and functional use of the paretic arm.

Participants will:

Receive standard physiotherapy sessions for 6 weeks

Be randomly assigned to either mirror therapy or robotic mirror mode intervention

Be evaluated using Fugl-Meyer Assessment, ARAT, Box and Block Test, Wolf Motor Function Test and Tactile/proprioceptive sensory test using Fugl-Meyer Assessment Sensory subsection.

详细描述

Upper extremity motor impairment is one of the leading causes of functional disability following stroke. Although conventional therapies promote some degree of recovery, restoring hand function remains a major challenge, particularly in patients with severe paresis. Mirror therapy has been widely used due to its affordability and portability. However, proprioceptive feedback limitations and the potential mismatch between visual and somatosensory input reduce its effectiveness.

This study investigates an innovative approach that combines visual illusion and proprioceptive input using a robotic hand device in mirror mode. The robotic intervention is designed to synchronize joint motion with visual feedback, potentially enhancing the mirror neuron system's activation and promoting neuroplastic changes more efficiently than conventional mirror therapy.

The study will be conducted over a 6-week period with stroke patients in the early subacute phase. Both groups will receive equivalent durations of upper limb training in addition to conventional physiotherapy.

This trial aims not only to compare motor outcomes but also to evaluate whether motor improvements translate into functional hand use and to explore differences in somatosensory gains between interventions. By addressing both visual and proprioceptive components of motor learning, this research may guide future clinical strategies for individualized stroke rehabilitation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Due to the nature of the intervention, participant and therapist blinding was not feasible, and outcome assessments were performed without masking.

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

  • Having a ischemic/hemorrhagic stroke diagnosis through MRI and/or CT
  • Volunteering to enter the study
  • First ever stroke or no sequeale (mRS 0)
  • Being in subacute/chronic phase of stroke (between 1st week to 1 year)
  • Having a adequate sitting balance or able to maintain upright sitting position for 30 minutes
  • Having a motor deficit in the hand (Brunnstrom hand motor recovery stages 1-4 )
  • Having a full range of motion in hand

排除标准

  • Severe Pain (VAS ≥ 8)
  • Having a neurological or orthopedic problem in hand
  • Severe spatial hemineglect (NIHSS 11th subscale> 1)
  • Spasticity (mAS ≥ 2)
  • Visual/auditory loss that affects treatment
  • Unstable Vital Signs

研究组 & 干预措施

Mirror Therapy Group

Active Comparator

The group who receives conventional mirror therapy

干预措施: Therapy Mirror (Device)

Hand Robot Group

Active Comparator

The group who receives mirror mode of a soft robotic glove

干预措施: Hand Robot Mirror Mode (Device)

结局指标

主要结局

Fugl Meyer Assesment

时间窗: 30 minutes

The Fugl-Meyer Assessment-Upper Extremity is a stroke-specific, performance-based impairment scale and gold-standard measure of post-stroke motor recovery that quantifies upper limb motor function using a standardized ordinal scoring system assessing reflex activity, movement control, coordination, and joint function.

次要结局

  • Action Research Arm Test(15 minutes)
  • Wolf Motor Function Test(30 minutes)
  • Box and Block Test(5 minutes)

研究者

发起方
Zeynep Lide Uz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeynep Lide Uz

Physiotherapist

Istanbul University - Cerrahpasa

研究点 (2)

Loading locations...

相似试验

Comparison of the Effectiveness of Mirror Therapy... | 临床试验