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ArticleTrials2024

Does somatosensory discrimination therapy alter sensorimotor upper limb function differently compared to motor therapy in children and adolescents with unilateral cerebral palsy: study protocol for a randomized controlled trial.

Lize Kleeren, Lisa Mailleux, Belinda McLean, Catherine Elliott, Griet Dequeker, Anja Van Campenhout, Jean-Jacques Orban de Xivry, Geert Verheyden, Els Ortibus, Katrijn Klingels and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06006065 (The Effectiveness of an Intensive Upper Limb Therapy Program Focused on Somatosensation in Children and Adolescents With Unilateral Cerebral Palsy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 42% 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.

NCT06006065 phase2unknown statusnot on this map

The Effectiveness of an Intensive Upper Limb Therapy Program Focused on Somatosensation in Children and Adolescents With Unilateral Cerebral Palsy

TypeinterventionalSponsorHilde FeysRan2023 to 2024Enrolled50ConditionsCerebral Palsy, Spastic, Hemiplegic Cerebral PalsyArmsUpper limb somatosensory discrimination therapy, Upper limb motor therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

11 authors at 4 institutions in 2 countries.

Lize KleerenKU Leuven, Department of Rehabilitation Sciences, Research Group for Neurorehabilitation, Leuven, B-3001, Belgium. lize.kleeren@kuleuven.be.ORCID http://orcid.org/0000-0002-4649-4662
Lisa MailleuxKU Leuven, Department of Rehabilitation Sciences, Research Group for Neurorehabilitation, Leuven, B-3001, Belgium.
Belinda McLeanCurtin School of Allied Health, Faculty of Health Sciences, Curtin University, Perth, Australia.
Catherine ElliottCurtin School of Allied Health, Faculty of Health Sciences, Curtin University, Perth, Australia.
Griet DequekerUniversity Hospitals Leuven, Cerebral Palsy Reference Centre, Leuven, B-3000, Belgium.
Anja Van CampenhoutKU Leuven, Child and Youth Institute, Leuven, B-3000, Belgium.
Jean-Jacques Orban de XivryKU Leuven, Leuven Brain Institute, Leuven, B-3000, Belgium.
Geert VerheydenKU Leuven, Department of Rehabilitation Sciences, Research Group for Neurorehabilitation, Leuven, B-3001, Belgium.
Els OrtibusKU Leuven, Child and Youth Institute, Leuven, B-3000, Belgium.
Katrijn KlingelsKU Leuven, Department of Rehabilitation Sciences, Research Group for Neurorehabilitation, Leuven, B-3001, Belgium.
Hilde FeysKU Leuven, Department of Rehabilitation Sciences, Research Group for Neurorehabilitation, Leuven, B-3001, Belgium.
KU Leuven · BEHasselt University · BERega Institute for Medical Research · BEThe Kids Research Institute Australia · AU

Funding

Fonds Wetenschappelijk Onderzoek 11PP224NFonds Wetenschappelijk Onderzoek G0C4919N
6 · The paper itself

Abstract

backgroundBesides motor impairments, up to 90% of the children and adolescents with unilateral cerebral palsy (uCP) present with somatosensory impairments in the upper limb. As somatosensory information is of utmost importance for coordinated movements and motor learning, somatosensory impairments can further compromise the effective use of the impaired upper limb in daily life activities. Yet, intervention approaches specifically designated to target these somatosensory impairments are insufficiently investigated in children and adolescents with uCP. Therefore, the aim of this randomized controlled trial (RCT) is to compare the effectiveness of somatosensory discrimination therapy and dose-matched motor therapy to improve sensorimotor upper limb function in children and adolescents with uCP, who experience somatosensory impairments in the upper limb. We will further explore potential behavioral and neurological predictors of therapy response.

methodsA parallel group, evaluator-blinded, phase-II, single-center RCT will be conducted for which 50 children and adolescents with uCP, aged 7 to 15 years, will be recruited. Participants will be randomized to receive 3 weekly sessions of 45 minutes of either somatosensory discrimination therapy or upper limb motor therapy for a period of 8 weeks. Stratification will be performed based on age, manual ability, and severity of tactile impairment at baseline. Sensorimotor upper limb function will be evaluated at baseline, immediately after the intervention and after 6 months follow-up. The primary outcome measure will be bimanual performance as measured with the Assisting Hand Assessment. Secondary outcomes include a comprehensive test battery to objectify somatosensory function and measures of bimanual coordination, unimanual motor function, and goal attainment. Brain imaging will be performed at baseline to investigate structural brain lesion characteristics and structural connectivity of the white matter tracts. DISCUSSION: This protocol describes the design of an RCT comparing the effectiveness of somatosensory discrimination therapy and dose-matched motor therapy to improve sensorimotor upper limb function in children and adolescents with uCP. The results of this study may aid in the selection of the most effective upper limb therapy, specifically for children and adolescents with tactile impairments.

trial registrationClinicalTrials.gov (NCT06006065). Registered on August 8, 2023.

Indexed as

Cerebral PalsyAdolescentBrainChildHandHumansRandomized Controlled Trials as TopicUpper ExtremityBimanual performanceNeuroimagingOccupational therapyPhysiotherapyRandomized controlled trialSensorimotor functionSomatosensationUnilateral cerebral palsyUpper extremity

Identifiers

PMID38409060
PMCPMC10895830
OpenAlexW4392163919

What OpenQuestion holds

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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.