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临床试验/NCT05204225
NCT05204225已完成不适用

ReHand. The First Tablet Solution for the Neurological Post-Stroke Rehabilitation of the Most Functional Body Segment, The Hand

University of Seville3 个研究点 分布在 2 个国家目标入组 33 人开始时间: 2022年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
3
主要终点
Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)

研究概览

简要总结

Stroke is the third leading cause of disability worldwide, with the hand being one of the segments whose affectation generates the greatest limitation in functional ability and quality of life. Neurorehabilitation is the most effective therapy as long as it is implemented both in the early (post-hospital stages) and in an intensive approach. However, the resources of healthcare systems are not enough to address the neurorehabilitation needs of patients with hand affectation after stroke. Thus, current scientific literature advocates transferring such rehabilitation to the patient's home through therapeutic exercise programs - whose clinical and economic effectiveness has already been demonstrated - as a way of reducing the consumption of resources. In order to achieve this, telerehabilitation is suggested as one of the most viable formats. However, current telerehabilitation systems such as video games and virtual reality do not provide a fully viable solution, mainly due to the lack of scalability and penetration of the technology, and the lack of a hand specific approach, whose importance is crucial in the recovery of function and autonomy in Activities of Daily Living (ADL). Different articles and reviews confirm the potential of tablet devices to solve these issues given their scalability and the multisensory feedback provided, making possible a more productive and intensive motor training and sensory stimulation in order to optimize cortical reorganization and neuroplasticity after a stroke. Both health professionals and patients have expressed the need for a specific Tablet application for neurorehabilitation of the hand after stroke, that follows the precepts established by the evidence. However, the lack of specific applications for this approach means that existing apps are used as an adaptation. Therefore, we propose the development and preliminary validation of ReHand, the first Tablet application developed according to the needs of healthcare professionals and patients, and the precepts of the most updated scientific literature, which allows the patient to perform an active therapy adapted to its hand limitations, and the healthcare professional to monitor their patient's home performance.

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)

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

  • Older than 18 years.
  • From 1 week to 6 months after stroke
  • Ischemic or hemorrhagic stroke confirmation by computed tomography or magnetic resonance imaging.
  • No previous impairments of the upper limb with the stroke affectation.
  • Score above 20 on the Minimental State Examination test.
  • Alertness and medical stability declared by the responsible neurologist and with ability to follow simple verbal commands
  • Ability to move fingers, even partially.

排除标准

  • Acute traumatic or orthopedic involvement of the limb in concern.
  • Unstable medical condition (life expectancy less than 3 months, uncontrolled hypertension, unstable angina, recent myocardial infarction, etc.).
  • Any medical condition that may confound interpretation of results or put the patient at risk (e.g. amputated finger, psychiatric illness, etc.).

结局指标

主要结局

Motor function of the upper limb using Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE)

时间窗: Change from Baseline Fugl-Meyer Motor Assessment of the Upper Extremity (FMA-UE) at 4 weeks.

A specific scale for the assessment of sensorimotor function of the upper limb after stroke. It includes 33 items, which are rated from 0 to 2 (0 = cannot perform it, 1 = partially perform it, 2 = maximum performance). Its overall score range from 0 to 66. Higher values correspond to greater motor ability.

次要结局

  • Dexterity assessed using the Nine Hole Peg Test(Change from Baseline Nine Hole Peg Test at 4 weeks)
  • Grip strength assessed using a hydraulic grip dynamometer(Change from Baseline Grip Strength at 4 weeks)
  • Pinch strength assessed using a hydraulic pinch dynamometer(Change from Baseline Pinch Strength at 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Rodríguez

Principal Investigator, PhD Candidate

University of Seville

研究点 (3)

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