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Набор скоро начнётся NCT07308054

The Effects of Fresnel Prism Glasses on Visual Perception, Balance, Gait and Functional Independence in Post-Stroke Patients

Без фазы С лечением Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fresnel Prism Glasse, Convetional physical therapy.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: 55 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This randomized controlled trial aims to evaluate the effects of Fresnel prism glasses on visual perception, balance, gait, and functional independence in post-stroke patients. Stroke survivors, particularly those with right hemisphere involvement, often experience visuospatial deficits such as unilateral spatial neglect, leading to impaired balance, abnormal gait, and reduced functional independence. Fresnel prism glasses offer a low-cost, non-invasive intervention that may improve visuospatial alignment and postural control by modifying visual input. Adult post-stroke patients will be randomly allocated into an intervention group receiving Fresnel prism glasses alongside conventional physical therapy, and a control group receiving conventional therapy alone. Outcome measures will include the Motor-Free Visual Perception Test, Berg Balance Scale, Functional Independence Measure, and JAKC Observational Gait Analysis. Assessments will be conducted at baseline, post-intervention, and follow-up. The study is expected to provide evidence on whether Fresnel prism glasses can serve as an effective adjunct to conventional rehabilitation for improving mobility, balance, and functional outcomes in stroke survivors.

Подробное описание

Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with impairments in balance, gait, motor function, and visuospatial perception. Among these deficits, unilateral spatial neglect (USN) is particularly common following right hemisphere stroke and significantly limits functional recovery. Individuals with USN often demonstrate impaired awareness of the contralesional space, distorted midline perception, postural asymmetry, and abnormal gait patterns, which collectively increase the risk of falls and dependence in activities of daily living. Despite advances in conventional stroke rehabilitation, including physical and occupational therapy, many patients continue to experience persistent functional limitations, highlighting the need for innovative and adjunctive rehabilitation strategies.

Recent developments in neurorehabilitation emphasize sensory-based interventions that promote neuroplasticity by modifying sensory input. Fresnel prism glasses represent a low-cost, non-invasive visual intervention designed to shift the visual field and facilitate visuospatial realignment. By altering visual input, Fresnel prisms may enhance sensory integration and improve postural control, balance, and gait performance in stroke survivors. Preliminary studies have demonstrated improvements in balance measures, gait symmetry, and visual perception following prism use; however, findings remain inconsistent, and evidence regarding functional outcomes and long-term effects is limited.

This randomized controlled trial aims to evaluate the effectiveness of Fresnel prism glasses as an adjunct to conventional physiotherapy in post-stroke patients. Eligible participants with a confirmed diagnosis of stroke will be randomly allocated into two groups: an experimental group receiving Fresnel prism glasses in addition to standard rehabilitation, and a control group receiving conventional physiotherapy alone. The intervention will be delivered over a defined treatment period, with assessments conducted at baseline and post-intervention.

Primary outcome measures will assess balance and postural control using standardized tools such as the Berg Balance Scale and Functional Reach Test. Secondary outcomes will include gait analysis, visual perception, and functional independence measured through validated clinical scales. The study also seeks to examine whether visual realignment through Fresnel prisms can facilitate weight transfer toward the affected side and reduce asymmetry during standing and walking.

The findings of this study are expected to contribute to the growing body of evidence on sensory-based rehabilitation interventions for stroke. By addressing current gaps related to functional outcomes and feasibility, this research may help establish Fresnel prism glasses as an effective, accessible adjunct therapy in stroke rehabilitation, particularly in resource-limited settings. Ultimately, the study aims to support improved mobility, independence, and quality of life among stroke survivors.

Вмешательства

  • Устройство Fresnel Prism Glasse
    Fresnel prism glasses consist of lightweight, flexible, press-on plastic prism lenses with a power of 15 prism diopters, affixed to the inner surface of standard spectacle lenses. The prisms are designed to shift the visual field horizontally to promote visuospatial realignment and improve sensory integration during functional activities. Participants assigned to the experimental group will wear Fresnel prism glasses during supervised physiotherapy sessions. The intervention will be administere
  • Поведенческое Convetional physical therapy
    Conventional physiotherapy will be provided to all participants in both groups according to standard neurorehabilitation protocols. The program will include balance exercises, gait training, strengthening exercises, postural alignment activities, weight-shifting exercises, and task-oriented functional training. Participants in the control group will receive conventional physiotherapy alone, without Fresnel prism glasses, for the same duration and frequency as the experimental group.

Первичные конечные точки

  • Motor-Free Visual Perception Test [Срок оценки: Baseline, before intervention, 8 weeks post intervention]
  • Berg Balance Scale [Срок оценки: baseline, before interventio, 8 weeks post intervention]
  • Functional Independence Measure [Срок оценки: baseline, before intervention, 8 weeks post intervention]
  • JAKC's Observational Gait Analysis [Срок оценки: Baseline, before intervention, 8 week post intervention]

Критерии участия

Inclusion Criteria Right hemisphere with left side neglect (14). Adults (40-65 years old) who have experienced an ischemic stroke for the first time (1-3 months post-stroke) are eligible (15) A score of 2-4 in the Functional Ambulation Category (FAC) (16) and MMSE ≥24 (to guarantee training-related cognitive ability)(17). Patient who can walk more than 10m Independently Exclusion Criteria Severe comorbidities, such as neurological or orthopedic disorders and impair gait(18) Hearing and vision problems that are not assisted. Patients with profound sensory impairment or significant cognitive dysfunction(19) Individuals who have recently suffered from cardiac failure, myocardial infarction, or other severe illnesses(20)

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Ha SY, Sung YH. Effects of Fresnel prism glasses on balance and gait in stroke patients with hemiplegia: A randomized controlled trial pilot study. Technol Health Care. 2020;28(6):625-633. doi: 10.3233/THC-191973. PMID 32280072

Идентификаторы

NCT: NCT07308054 · UBAS/ERB/FpRS/25/035

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗