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Набор по приглашению NCT06696989

Comparative Effects of Frenkel's and Core Stability Exercises in Children With Cerebral Palsy

Без фазы С лечением Cerebral Palsy (CP)

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: Frenkel's exercises, Core stability exercises.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy (CP). 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

Comparative Effects of Frenkel's and Core Stability Exercises on Coordination and Balance in Children With Cerebral Palsy

Обзор

The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy.

Подробное описание

Cerebral palsy (CP) is a brain injury that manifests as a mobility and posture impairment in infancy or early childhood. Frenkel exercises are series of movements with increasing difficulty that can be performed by ataxic patients in order to regain coordinated, smooth and rhythmic movement. The Core stability Exercises are for the spine, pelvis, and kinetic chain to all balance properly under stress, core stability is necessary. The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy. This will be a Randomized Clinical Trial in which 50 participants with cerebral palsy will be included as per sample size calculation through non probability convenience sampling technique. The study will be single blinded. Participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two Groups. Group A will receive Frenkel's exercises and Group B will receive core stability exercises, both groups will receive the treatment for 40 minutes with the routine physical therapy for 20 minutes and short-term rest intervals in between for 3 alternative days per week for 12 weeks. Participants initial screening will be done through Gross Motor Function Classification System (GMFCS). The balance will be assessed through the Pediatric Balance Test (PBS), coordination will be assessed through Finger and Nose Test, Heel Shin Test, Catching and Throwing Tasks.

Вмешательства

  • Другое Frenkel's exercises
    In this group, participants will receive Frenkel's exercises, and the total treatment session will be 60 minutes of routine physical therapy, i.e., breathing, stretching, ROM's, and joint mobility, with rest intervals in between for 20 minutes. To begin the intervention, the investigator will perform Frenkel's exercises for 40 minutes in total, with rest intervals between each exercise, initially performing 5 repetitions and then gradually progressing to 10 and then 15 repetitions, respectively,
  • Другое Core stability exercises
    This group participants will receive core stability exercises, and the total treatment session will also be 60 minutes. The routine physical therapy includes breathing, stretching, joint rotations, ROM's, and frequent periods of rest in between the treatment sessions. To begin the intervention the investigator will perform core stability exercises for 40 minutes in total with rest intervals between each exercise and initially performing 5 repetitions and then gradually progressing to 10 and then

Первичные конечные точки

  • Finger to nose test [Срок оценки: 12th week]
  • Heel shin test [Срок оценки: 12th week]
  • Catching and throwing tasks [Срок оценки: 12th week]
  • PBS (Pediatric Ballance Scale) [Срок оценки: 12th week]

Критерии участия

Критерии включения

  • The participants fulfilling the given criteria will be included.
  • Age: 6 To 12 Years
  • Gender: Both male and female
  • Children with ataxic cerebral palsy
  • Children having level II and III on Gross Motor Functional Classification System (GMFCS)
  • Children able to understand the test instruction, able to sit and stand.
  • Children with and without using Botulinum Toxin Injections
  • The Pediatric Balance Scale (PBS) of 54.6

Критерии исключения

  • Severe Cognitive Dysfunction
  • Visual problems
  • Vestibular Dysfunction
  • Uncontrolled epilepsy
  • Severe Orthopedic Condition affecting Lower limbs Mobility

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 · 1 центр
  • RehabCure — Lahore

Публикации

  • Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30. PMID 34325496
  • Hlaing SS, Puntumetakul R, Khine EE, Boucaut R. Effects of core stabilization exercise and strengthening exercise on proprioception, balance, muscle thickness and pain related outcomes in patients with subacute nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Nov 30;22(1):998. doi: 10.1186/s12891-021-04858-6. PMID 34847915
  • Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9. PMID 33557483
  • Ali MS, Awad AS, Elassal MI. The effect of two therapeutic interventions on balance in children with spastic cerebral palsy: A comparative study. J Taibah Univ Med Sci. 2019 Jul 26;14(4):350-356. doi: 10.1016/j.jtumed.2019.05.005. eCollection 2019 Aug. PMID 31488967
  • Manko G, Pieniazek M, Tim S, Jekielek M. The Effect of Frankel's Stabilization Exercises and Stabilometric Platform in the Balance in Elderly Patients: A Randomized Clinical Trial. Medicina (Kaunas). 2019 Sep 11;55(9):583. doi: 10.3390/medicina55090583. PMID 31514453
  • Horber V, Fares A, Platt MJ, Arnaud C, Krageloh-Mann I, Sellier E. Severity of Cerebral Palsy-The Impact of Associated Impairments. Neuropediatrics. 2020 Apr;51(2):120-128. doi: 10.1055/s-0040-1701669. Epub 2020 Mar 2. PMID 32120428
  • Graham D, Paget SP, Wimalasundera N. Current thinking in the health care management of children with cerebral palsy. Med J Aust. 2019 Feb;210(3):129-135. doi: 10.5694/mja2.12106. Epub 2019 Feb 10. PMID 30739332
  • Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022. PMID 35941906

Идентификаторы

NCT: NCT06696989 · REC/RCR&AHS/24/0240

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗