دورية أكاديمية
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Psychostimulant Medications for Physical Function and Spasticity in Children With Cerebral Palsy: Protocol for a Randomized Controlled Trial.

التفاصيل البيبلوغرافية
العنوان: Psychostimulant Medications for Physical Function and Spasticity in Children With Cerebral Palsy: Protocol for a Randomized Controlled Trial.
المؤلفون: Alotaibi M; Department of Rehabilitation, Faculty of Applied Medical Sciences, Northern Border University, Arar, Saudi Arabia.; Center for Health Research, Northern Border University, Arar, Saudi Arabia., Almutairi AB; Department of Physical Therapy, Faculty of Allied Health, Kuwait University, Kuwait City, Kuwait., Alhirsan S; Department of Physical Therapy, College of Applied Medical Sciences, Jouf University, Aljouf, Saudi Arabia., Alkazemi A; Department of Pharmacy Practice, College of Pharmacy, Kuwait University, Kuwait City, Kuwait., Alharbi M; Department of Pharmacy Practice, College of Pharmacy, Kuwait University, Kuwait City, Kuwait., Alrashdi N; Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Majmaah University, Al-Majmaah, Saudi Arabia.; The Health and Scientific Research Center, Majmaah University, Majmaah, Saudi Arabia., Taqi A; Department of Pharmacy Practice, College of Pharmacy, Kuwait University, Kuwait City, Kuwait., Alamiri B; Kuwait Center for Mental Health, Public Authority for Disability Affairs, Almanara, Kuwait., Vogtle L; Department of Occupational Therapy, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States., Alqahtani MM; Department of Respiratory Therapy, College of Applied Medical Sciences, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.; King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
المصدر: JMIR research protocols [JMIR Res Protoc] 2024 Mar 05; Vol. 13, pp. e53728. Date of Electronic Publication: 2024 Mar 05.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101599504 Publication Model: Electronic Cited Medium: Print ISSN: 1929-0748 (Print) Linking ISSN: 19290748 NLM ISO Abbreviation: JMIR Res Protoc Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Toronto : JMIR Publications
مستخلص: Background: Cerebral palsy (CP) is a prevalent nonprogressive disorder that leads to impaired movement (ie, spasticity), posture, and balance, which affects functions such as walking and upper extremity tasks. Current medical treatments show efficacy in improving motor performance but have considerable side effects. Emerging off-label use of central nervous system (CNS) medications for improving motor performance has shown promising results in children with CP and other populations.
Objective: The aim of this study is to describe a protocol for a pilot randomized controlled trial (RCT) to examine the safety, tolerability, and efficacy of methylphenidate (MPH) and modafinil on spasticity and motor performance in children with CP.
Methods: This will be a protocol study for a pilot, triple-masked, placebo-controlled RCT (a class I trial following the American Academy of Neurology criteria) with blinded patients, outcome assessors, and intervention delivery team. Eligible children should be diagnosed with CP levels I or II based on the Gross Motor Function Classification System and be aged between 7 and 12 years. Thirty-six children with CP will be randomized into 3 groups to receive (1) MPH (2.5 mg of MPH + 100 mg placebo), (2) modafinil (100 mg modafinil + 2.5 mg placebo), or (3) a placebo (2.5 mg placebo + 100 mg placebo), in addition to physical therapy for 12 weeks. Primary outcomes include the Gross Motor Function Measure-66 and the Modified Ashworth Scale. Secondary outcomes include the Timed Up and Go test, 5 Time Sit to Stand test, Modified Clinical Test for Sensory Interaction of Balance, and 10-Meter Walk Test.
Results: The protocol has been accepted by Kuwait University (VDR/EC-225) and the Ministry of Health of Kuwait (2022/2157). The inclusion of participants will start in June 2024.
Conclusions: The combination of CNS stimulant medications and controlling for rehabilitation has not been studied yet. The findings of this study may determine if using CNS stimulant medications is beneficial for the reduction of spasticity and improvement of physical function in children with spastic CP.
Trial Registration: ClinicalTrials.gov NCT05675098; https://clinicaltrials.gov/study/NCT05675098.
International Registered Report Identifier (irrid): PRR1-10.2196/53728.
(©Mansour Alotaibi, Anwar B Almutairi, Saleh Alhirsan, Afrah Alkazemi, Maha Alharbi, Naif Alrashdi, Ahmad Taqi, Bibi Alamiri, Laura Vogtle, Mohammed M Alqahtani. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.03.2024.)
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فهرسة مساهمة: Keywords: CNS stimulants; CP; Kuwait; central nervous system; cerebral palsy; child; children; efficacy; gross motor function; impairment; medications; methylphenidate; modafinil; motor performance; movement; pediatric; pediatrics; physical function; physical therapy; psychostimulant; rehabilitation; safety; spasticity; tolerability
سلسلة جزيئية: ClinicalTrials.gov NCT05675098
تواريخ الأحداث: Date Created: 20240305 Latest Revision: 20240322
رمز التحديث: 20240322
مُعرف محوري في PubMed: PMC10951828
DOI: 10.2196/53728
PMID: 38441919
قاعدة البيانات: MEDLINE
الوصف
تدمد:1929-0748
DOI:10.2196/53728