Evidence map›Paper›PMID 32807229›Full record

ArticleTrials2020

Integrative medicine rehabilitation for children with cerebral palsy: a study protocol for a multicenter pragmatic randomized controlled trial.

Mi-Joo Lee, Young-Ju Yun, Sun-Ae Yu, Yong-Beom Shin, Soo-Yeon Kim, Jun-Hee Han

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Meridian acupuncture plus massage for children with spastic cerebral palsy.American journal of translational research · 2021
    Article
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

6 authors.

Mi-Joo LeeDepartment of Korean Gynecology, CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-Do, South Korea.
Young-Ju YunDepartment of Integrative Medicine, School of Korean Medicine, Pusan National University, 20, Geumo-ro Mulgeum-eup, Yangsan-si Gyeongsangnam-do, 50612, Pusan, Republic of Korea. mdkmdyun@pusan.ac.kr.ORCID http://orcid.org/0000-0002-4598-2322
Sun-Ae YuDepartment of Pediatrics, College of Korean Medicine, Dong-Eui University, Pusan, South Korea.
Yong-Beom ShinDepartment of Rehabilitation Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Pusan, South Korea.
Soo-Yeon KimDepartment of Rehabilitation Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, South Korea.
Jun-Hee HanDepartment of Statistics & Institute of Statistics, Hallym University, Chuncheon, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTraditional Korean medicine (TKM) has been employed for the treatment of children with cerebral palsy in Korea; however, the addition of TKM to usual rehabilitation (UR) treatment is hindered by insufficient evidence of clinical improvement with TKM in patients with cerebral palsy. In this study, we will evaluate the effectiveness and safety of integrative medicine rehabilitation (IMR) for cerebral palsy through a randomized controlled clinical study.

methodsEighty children (2-6 years old) diagnosed with cerebral palsy will be recruited and randomly divided into groups A and B. Patients in group A will receive IMR with UR, while those in group B will receive only UR during weeks 1-12 of the study. IMR includes acupuncture treatment (head and limb acupuncture) three times a week and the administration of herbal medicine (Yukgunza-tang and Yukmijihwang-tang extracts) twice a day in parallel with UR. Evaluations will be conducted at the beginning of the study and at 12 and 24 weeks (follow-up). The primary outcome is the Gross Motor Function Measure-88 score, and the secondary outcomes are the scores for the Goal Attainment Scale, Korean Bayley Scales of Infant Development III, and the Pediatric Quality of Life Inventory, and adverse events. DISCUSSION: This will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea. The results will help to demonstrate if IMR is an effective therapeutic approach for cerebral palsy.

trial registrationMinistry of Food and Drug Safety 31361 ( http://www.mfds.go.kr ). Registered on 29 June 2017. Clinical Research Information Service KCT0002620 ( https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=9819 ). Registered on 29 December 2017.

Indexed as

Cerebral PalsyIntegrative MedicineChildChild, PreschoolHumansInfantMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeRepublic of KoreaTreatment OutcomeCerebral palsyChildrenGoal attainment scale (GAS)Gross motor function measure (GMFM)Integrative medicine rehabilitation (IMR)Korean Bayley scales of infant development III (K-BSID III)Pediatric quality of life inventory (PedsQL)Randomized controlled trialRehabilitation

Identifiers

PMID32807229
PMCPMC7430116

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.