Идёт набор NCT04975646

Goal Attainment Scaling in Upper Limb Spasticity Treatment

Без фазы С лечением Ischemic Stroke Hemorrhagic 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: Prescribed exercise program.
Кому может быть актуально: Состояния в реестре: Ischemic Stroke, Hemorrhagic Stroke. Базовые параметры: от 18 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: Словения
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Goal Attainment Scaling in Upper Limb Spasticity Treatment With Botulinum Toxin and the Influence of Regular Exercise for Spastic Upper Limb on Quality of Life in Patients After Stroke

Обзор

Patients after stroke with upper limb spasticity treated with botulinum toxin-A (BTX-A) will be included in this two-part study. In the first part, goal attainment scaling and comprehensive assessment of motor functioning will be performed before BTX-A application and after two weeks. In the second part, the patients will be randomised into a test group performing prescribed regular exercise for two weeks and a control group exercising at their own discretion during the same period, whereby the patients' health-related quality of life will be assessed at the beginning and end of the two-week period.

Подробное описание

Goal setting will be performed by the patient together with the physician according to the SMART principle (specific, measureable, achievable, realistic, time bound). The goals will be classified according to the International Classification of Functioning, Disability and Health. Goal attainment will be assessed using the Goal Attainment Scale - Light. Comprehensive assessment of motor functioning will address range of motion, spasticity, pain, degree of motor disability and degree of dependence in daily activities. The prescribed exercises for the test group will be passive or active, depending on spasticity of the impaired upper limb. Both groups will keep an Exercise Diary during the second part of the study.

Вмешательства

Поведенческое Prescribed exercise program
Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.

Первичные конечные точки

GAS-Light [Срок оценки: At baseline, after 2 weeks (i.e., at the end of the 1st part of the study)]
SQoL-6D [Срок оценки: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]

Вторичные конечные точки (6)

ROM [Срок оценки: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
MAS [Срок оценки: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
PSFS [Срок оценки: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
VAS [Срок оценки: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
BSR [Срок оценки: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]
MRS [Срок оценки: Start of the 2nd part of the study (i.e., after 2 weeks), end of the 2nd part of the study (i.e., after 4 weeks)]

Критерии участия

Критерии включения

patient's or caregiver's approval
ischemic or hemorrhagic stroke diagnosed using head CT/MRI
at least one upper limb muscle spasticity (MAS ≥ 3)
candidate for BTX-A treatment or already given BTX-A in the past
patient's or caregiver's capability for goal attainment protocol cooperation (Mini Mental Examination ≥ 24 points)