Evidence map›Paper›PMID 38441919›Full record

ArticleJMIR research protocols2024

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

Mansour Alotaibi, Anwar B Almutairi, Saleh Alhirsan, Afrah Alkazemi, Maha Alharbi, Naif Alrashdi, Ahmad Taqi, Bibi Alamiri, Laura Vogtle, Mohammed M Alqahtani

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JMIR research protocols, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05675098 (Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 96% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05675098 early_phase1not yet recruitingnot on this map

Effect of Central Nervous System Stimulants on Physical Function in Children With Cerebral Palsy: A Pilot Randomized Controlled Trial

TypeinterventionalSponsorKuwait UniversityRan2023 to 2027Enrolled30ConditionsNeurodevelopmental Disorders, Cerebral PalsyArmsMethylphenidate, Modafinil, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 3 countries.

Mansour Alotaibi *Department of Rehabilitation, Faculty of Applied Medical Sciences, Northern Border University, Arar, Saudi Arabia.ORCID https://orcid.org/0000-0003-2378-3186
Anwar B Almutairi *Department of Physical Therapy, Faculty of Allied Health, Kuwait University, Kuwait City, Kuwait.ORCID https://orcid.org/0000-0001-5489-9929
Saleh Alhirsan *Department of Physical Therapy, College of Applied Medical Sciences, Jouf University, Aljouf, Saudi Arabia.ORCID https://orcid.org/0009-0007-5701-391X
Afrah Alkazemi *Department of Pharmacy Practice, College of Pharmacy, Kuwait University, Kuwait City, Kuwait.ORCID https://orcid.org/0000-0003-2456-8736
Maha Alharbi *Department of Pharmacy Practice, College of Pharmacy, Kuwait University, Kuwait City, Kuwait.ORCID https://orcid.org/0000-0003-3493-7099
Naif AlrashdiDepartment of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Majmaah University, Al-Majmaah, Saudi Arabia.ORCID https://orcid.org/0000-0002-2263-1968
Ahmad TaqiDepartment of Pharmacy Practice, College of Pharmacy, Kuwait University, Kuwait City, Kuwait.ORCID https://orcid.org/0009-0000-4299-3707
Bibi AlamiriKuwait Center for Mental Health, Public Authority for Disability Affairs, Almanara, Kuwait.ORCID https://orcid.org/0000-0001-7133-9069
Laura VogtleDepartment of Occupational Therapy, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.ORCID https://orcid.org/0000-0003-4559-0537
Mohammed M AlqahtaniDepartment of Respiratory Therapy, College of Applied Medical Sciences, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.ORCID https://orcid.org/0000-0003-1656-0881
Kuwait University · KWJouf University · SAKing Saud bin Abdulaziz University for Health Sciences · SAMajmaah University · SANorthern Border University · SAUniversity of Alabama at Birmingham · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCerebral 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.

objectiveThe 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.

methodsThis 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.

resultsThe 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.

conclusionsThe 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 registrationClinicalTrials.gov NCT05675098; https://clinicaltrials.gov/study/NCT05675098. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53728.

Indexed as

central nervous systemcerebral palsychildchildrenCNS stimulantsCPefficacygross motor functionimpairmentKuwaitmedicationsmethylphenidatemodafinilmotor performancemovementpediatricpediatricsphysical functionphysical therapypsychostimulantrehabilitationsafetyspasticitytolerability

Identifiers

PMID38441919
PMCPMC10951828
OpenAlexW4392473527

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.