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Идёт набор NCT07484464

Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome

Без фазы С лечением Down Syndrome

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: OTAGO Exercises.
Кому может быть актуально
Состояния в реестре: Down Syndrome. Базовые параметры: 8 лет — 14 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 OTAGO Exercise Program On Balance, Endurance And Motor Coordination In Children With Down Syndrome

Обзор

The study will use a quasi-experimental design conducted over ten months in pediatric physiotherapy departments of tertiary care hospitals and special education schools. It will include 30 children aged 6-14 years with mild to moderate intellectual disability, selected after eligibility screening and guardian consent. Outcomes will be assessed using BOT-2, Berg Balance Scale, MMSE-C, and Six-Minute Walk Test to measure motor skills, balance, cognition, and endurance. Ethical approval will be obtained from the Research Ethical Committee of Riphah International University, Lahore, and data will be analyzed using SPSS version 26.0.

Подробное описание

Children with Down syndrome (DS) commonly face challenges such as reduced muscle tone, joint instability, and impaired coordination, all of which can impact their balance, mobility, and physical independence. While Otago exercises have proven effective in enhancing balance and coordination in older adults and adults with Down syndrome, their application in children with DS remains limited and underexplored.

The study will employ a quasi-experimental design. Data will be collected from the pediatric physiotherapy departments of tertiary care hospitals and special education schools. The duration of the study will be ten months following the approval of the research synopsis. A total of 30 children, aged between 6 and 14 years and diagnosed with mild to moderate intellectual disability, will be recruited. All referred participants will undergo screening to assess their eligibility based on predefined inclusion criteria. Informed consent will be obtained from the guardians of participants who meet the eligibility requirements prior to their enrollment in the study. Outcome measures will include the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2), the Berg Balance Scale (BBS), and Mini-Mental State Examination for Children (MMSE-C), and the Six-Minute Walk Test (6MWT) to assess endurance capacity. The research synopsis will be submitted to the Research Ethical Committee of Riphah International University, Lahore, for ethical approval. Data will be analyzed using SPSS version 26.0

Вмешательства

  • Другое OTAGO Exercises
    1. WarmUp (510 mins) Marching on the spot Gentle arm swings Neck, shoulder, ankle movements 2. Strength Exercises (3 times/week using ankle weights): Knee Extensions (seated leg straightening) Knee Flexions (standing leg curls) Hip Abductions (leg lifts to the side) Hip Extensions (leg lifts backward) Calf Raises (rise onto toes, holding support) Toe Raises (lift toes while heels remain on ground) 3. Balance Exercises (at least 3 times/week): Heel to Toe Stand One Leg Stand Sit to Stand

Первичные конечные точки

  • Bruininks-Oseretsky Test of Motor Proficiency [Срок оценки: Baseline, 8 weeks]
  • Berg Balance Scale [Срок оценки: Baseline, 8 weeks]
  • Mini Mental State Examination (MMSE) [Срок оценки: Baseline, 8 weeks]
  • Six-Minute-Walk-Test (6MWT) [Срок оценки: Baseline, 8 weeks]

Критерии участия

Критерии включения

  • • Clinically diagnosed with Trisomy 21.
  • Aged between 8-14 years.(29)
  • Able to follow basic verbal instructions.
  • Ambulatory with or without assistive devices

Критерии исключения

  • • Severe visual or auditory impairments.
  • Patient with moderate to severe cognitive impairments. (29)
  • Co-morbid neurological conditions (e.g., uncontrolled seizures, cerebral palsy).
  • Cardiac contraindications to moderate physical activity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Gulab Devi — Lahore

Публикации

  • Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4. PMID 20817938

Идентификаторы

NCT: NCT07484464 · REC/RCR&AHS/FATIMATARIQ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗