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Идёт набор NCT06893718

Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.

Без фазы С лечением Autism Spectrum Disorder

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: Compressions Stocking Group, Treadmill Training Group.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 6 лет — 12 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Treadmill Training With and Without Compression Stockings on Toe Walking and Balance in Children With Autism.

Обзор

Autism Spectrum Disorder (ASD) affects around 1.7% of US children, with co-occurring conditions like ADHD, anxiety, and epilepsy complicating daily functioning. Early intervention strategies, such as sensory-based therapies and physical exercises like treadmill training, are used to improve motor skills and overall functioning in children with ASD. A randomized controlled trial is being conducted to evaluate the impact of treadmill interventions on children with toe-walking behaviors. Participants will be assigned to either Group A or Group B, with treadmill sessions with or without compression stockings. The study aims to investigate the potential benefits of treadmill therapy as part of a multidisciplinary approach to treating ASD.

Подробное описание

Autism spectrum disorder (ASD) is a complex neurodevelopmental condition characterized by difficulties in social communication, repetitive behaviors, and sensory sensitivities, typically appearing early in life. The disorder's prevalence varies globally, with recent estimates in the US showing approximately 1.7% of children affected. Diagnosis relies on comprehensive evaluations using standardized tools, such as the Autism Diagnostic Observation Schedule, to assess behavioral patterns and developmental history. Individuals with ASD often experience cooccurring conditions like ADHD, anxiety, and epilepsy, which can further impact daily functioning. Motor abnormalities, including toe-walking, are observed in some cases and may indicate underlying neurological issues or developmental delays. Early intervention, including sensory-based therapies and physical exercises like treadmill training, aims to improve motor skills and overall functioning in children with ASD, highlighting the importance of multidisciplinary support for optimal developmental outcomes.

The study will be a Randomized Controlled Trial (RCT) designed to investigate the impact of treadmill interventions on children with autism spectrum disorder (ASD) who exhibit toe-walking behaviors. Legal guardians will receive comprehensive information about the research objectives, methods, and potential benefits, and informed consent will be obtained prior to participation. Initial assessments will thoroughly evaluate each participant's baseline strength, frequency of toe walking, and balance using standardized tools like the 50-foot walk test for toe walking and the Pediatric Balance Scale for balance assessment. Participants meeting specific inclusion criteria: children diagnosed with ASD, displaying toe walking more than 30% of the time, and compliant with the treatment protocol and Exclusion Criteria: Associated orthopedic conditions, underlying genetic disorders, global developmental delay, patient's parents'/guardians' refusal to provide informed consent will be assigned to either Group A or Group B by Non- Probability Convenient Sampling technique. Group A will undergo treadmill sessions while wearing compression stockings for one hour before and during a 10-minute treadmill walk, with incline adjustments from 10% to 12% over six weeks. Group B will undergo identical treadmill sessions without compression stockings. The study will be conducted in a controlled environment at a single autism center, ensuring consistent conditions for both groups. IBM SPSS Statistics version 27 will be used for data analysis.

Вмешательства

  • Другое Compressions Stocking Group
    * Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed * Speed: Constant speed of 3.4 mph. * Warm up: Calf stretch 10 reps/ 2 sets.
  • Другое Treadmill Training Group
    * Incline: Initially 5% incline and after 4 weeks an incline of 10% will be observed * Speed: Constant speed of 3.4 mph. * Warm up: Calf stretch 10 reps/ 2 sets.

Первичные конечные точки

  • Pediatric Balance Scale [Срок оценки: baseline, 3rd week, 6th week.]
  • Toe Walking [Срок оценки: baseline, 3rd week, 6th week.]

Критерии участия

Критерии включения

  • Children with ASD who toe walk.
  • Gait disorder more than 30% of the time.
  • Compliance with our treatment protocol.
  • Children whose guardians agreed on the study

Критерии исключения

  • Associated orthopedic conditions.
  • Underlying genetic disorders.
  • Global developmental delay.
  • Patient's parents'/guardians' refusal to provide informed consent

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
Другое

Центры проведения

Пакистан · 1 центр
  • Muhammad Asif Javed — Lahore

Публикации

  • Dehghani M, Jafarnezhadgero AA, Darvishani MA, Aali S, Granacher U. Effects of an 8-week multimodal exercise program on ground reaction forces and plantar pressure during walking in boys with autism spectrum disorder. Trials. 2023 Mar 8;24(1):170. doi: 10.1186/s13063-023-07158-7. PMID 36890589
  • Grandits JB, Kent HW, Sanborn SM, Pilcher JJ. The effect of compression on repetitive behaviors and task participation in children with autism spectrum disorder. Front Psychol. 2023 Dec 13;14:1292439. doi: 10.3389/fpsyg.2023.1292439. eCollection 2023. PMID 38162972

Идентификаторы

NCT: NCT06893718 · REC/RCR/AHS/25/qutbia abaq

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗