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Идёт набор NCT06748248

Suspension Therapy Effects on Mobility and Balance in Down Syndrome

Без фазы С лечением Down Syndrome (DS)

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: suspension Therapy, Routine Treatment.
Кому может быть актуально
Состояния в реестре: Down Syndrome (DS). Базовые параметры: 3 лет — 6 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
Пакистан
Следующий шаг
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Официальное название

Effects of Suspension Therapy on Mobility and Balance in Children With Down Syndrome

Обзор

Down syndrome (DS) is one of the most common congenital disorders. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. These factors are responsible for the developmental challenges faced by children with Down syndrome. These individuals also present with balance dysfunctions. Neuromuscular and musculoskeletal impairments due to the chromosomal abnormality lead to developmental delay. These children also exhibit poor balance with greater instability and inefficient compensatory mechanisms including altered center of pressure displacement and trunk stiffening that predisposes them to falls. The aim of this study is to determine the Effects of Suspension Therapy (ST) on mobility and balance of children with Down syndrome. Suspension Therapy using Universal exercise Unit (UEU) is a three dimensional (3D) cage, consists of system of pulleys, suspensions, belts for supporting and elastic cords. Suspension Therapy is based on the concept of unloading the body against gravity and to perform movement of weak part of body.

Подробное описание

The current study will be Randomized Controlled Trial. Inclusion criteria for the study will be children with Down syndrome (DS) of mild to moderate mental retardation aged between 3 and 6 years. Patients with any cardiac issue and orthopedic limitation to exercise such as hip, knee, foot or spinal deformities will be excluded from the study. A sample of 26 children with DS will be selected from both genders. Tools used for data collection will be Pediatric Balance scale (PBS), Four square step test (FSST), Timed up and Go test (TUG) and 1Minute Walk Test (1MWT). Participants will be measured before and after treatment to assess changes. Interventions are carried out 5 days in a week for one hour daily. In this study descriptive statistical tools will used to analyze the data. Data will be analyzed through SPSS version 23.00.

Вмешательства

  • Другое suspension Therapy
    suspension therapy for individuals with Down syndrome is an approach that focuses on improving mobility and balance through different activities that will be conducted through universal exercise unit. This method involves organizing individuals with Down syndrome into two groups. Group A will perform Suspension Therapy in addition to routine physical therapy. These routine exercises will consist of stretching exercises (arm raises, chest stretch, leg swings, hamstring stretch, cat-cow poses, sta
  • Другое Routine Treatment
    Group B will perform routine physical therapy (RPT) alone. These routine exercises will consist of stretching exercises (particularly upper and lower body stretches and full body stretches). Stretches will be gentle and avoid bouncing. Hold for each stretch will be 15-30 seconds. Balance and coordination exercises (Walking on balance beams, obstacle courses) will be performed as RPT. The exercise program will gradually increase in intensity in accordance with each participant's functional improv

Первичные конечные точки

  • 1 Minute Walk Test [Срок оценки: 1 minute]
  • Four Square Step Test [Срок оценки: 15 seconds]
Вторичные конечные точки (2)
  • Pediatric balance scale [Срок оценки: 15 to 20 minutes]
  • Timed Up and Go Test [Срок оценки: The Timed Up and Go Test typically takes about 5 to 10 minutes to complete. This includes time for instructions the actual test which usually lasts 10 to 30 seconds depending on the individual and scoring.]

Критерии участия

Inclusion Criteria: • Diagnosed children with Down syndrome with mild (IQ: 69-50) to moderate (IQ: 50-35) mental retardation

  • Aged between 3 to 6 years
  • Both gender
  • Able to follow the instructions
  • Able to stand and walk

Exclusion Criteria: • Any Cardiovascular disease

  • Visual and Hearing impairment
  • Orthopedic limitation to exercise such as hip, knee, foot or spinal deformities

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
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 2 центра
  • Riphah International University — Lahore
  • Riphah International Universiy — Lahore

Публикации

  • Mendez-Martinez M, Rodriguez-Grande EI. Effects of therapeutic exercise on the motor function of adults with Down syndrome: a systematic review and meta-analysis. Sci Rep. 2023 Dec 11;13(1):21962. doi: 10.1038/s41598-023-48179-1. PMID 38081839

Идентификаторы

NCT: NCT06748248 · REC/RCR/AHS/24/Sidra Rukhsar

Первоисточники (государственные реестры)

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