- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03726385
Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy
29. oktober 2018 opdateret af: Dilara Merve Sarı
Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions
The purpose of the study was to investigate the effectiveness of Cogniboard® Light Trainer, an education device with visual feedback that is added to the Neurodevelopmental Therapy Method (NDT) based upper extremity rehabilitation in children with cerebral palsy, on upper extremity functions such as joint range of motion (ROM), muscle tone, grip strength, pinch strength and functional abilities.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Children with the diagnosis of Cerebral Palsy, aged between 4 and 18 years were included in the study, who were volunteered to participate.
The participants were randomly assigned into two groups; A total of 16 sessions of rehabilitation program were applied for 2 days a week for 8 weeks.
The treatment programs applied are; Group I: NDT based upper extremity rehabilitation, Group II: NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training.
In the cases, pre- and post-treatment spasticity was defined with 'Modified Ashworth Scale'; upper extremity joint range of motion (ROM) with 'goniometer'; grip and pinch strength with 'dynamometer'; hand skills with 'Minnesota Hand Skill Test'; functional abilities with 'Childhood Health Assessment Questionnaire (CHAQ) and functional level with 'Gross Motor Function Classification System (GMFCS)'.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
38
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Eyup
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Istanbul, Eyup, Kalkun, 34050
- Dilbade Education and Rehabilitation Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Participants of the study were selected among the children who applied to Dilbade Education and Rehabilitation Center for rehabilitation.
Simple random sampling method was applied to group selection.
Beskrivelse
Inclusion Criteria:
- Having the diagnosis of Cerebral Palsy (CP),
- Aged between 4-18,
- Having 1+ upper extremity spasticity at max according to the Modified Ashworth Scale (MAS),
- To be able to cooperate with exercises
Exclusion Criteria:
- Having mental retardation report,
- Having congenital deformities,
- Epilepsy history,
- Having cardiac, orthopedic, visual and hearing problems,
- Application of Botulinum Toxin (BOTOX) to the upper extremity in past six month.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Group I
Group I: The control group.
Participants in this group received only NDT based upper extremity rehabilitation.
Number of the participants were 19.
|
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Group II
Group II: The study group.
Participants in this group received NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training.
Number of the participants were 19.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Range of motion (ROM)
Tidsramme: Eight weeks
|
Upper extremity ROM measured with universal goniometer.
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Eight weeks
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Spasticity
Tidsramme: Eight weeks
|
Spasticity defined with Modified Ashworth Scale (MAS).
The MAS measures resistance during passive soft-tissue stretching.
Scoring: 0= normal tone.
1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension.
1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM.
2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved.
3= considerable increase in muscle tone, passive movement difficult.
4= affected part(s) rigid in flexion or extension.
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Eight weeks
|
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Grip and pinch strength
Tidsramme: Eight weeks
|
Grip and pinch strength measured with dynamometer.
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Eight weeks
|
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Hand Skills
Tidsramme: Eight weeks
|
Hand skills was assessed with Minnesota Dexterity Test (MMDT).
MMDT is a standardized test for the evaluation of a subject's ability to move small objects various distances.
The score on the test is the total seconds required to complete chosen number of test trials.
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Eight weeks
|
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Functional Abilities
Tidsramme: Eight weeks
|
Functional abilities was assessed with Childhood Health Assessment Questionnaire (CHAQ).
CHAQ is used to assess health status in children.
It assesses functional ability in 8 domains of physical function (30 items) for children.
Each item is scored on a four point scale ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), 3 (unable to do).
The mean score of the eight domains finally makes up the disability index and ranges from 0 (no disability) to 3 (disabled).
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Eight weeks
|
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Functional Level
Tidsramme: Eight weeks
|
Functional level was defined with Gross Motor Function Classification System (GMFCS).
GMFCS looks at movements such as sitting, walking and use of mobility devices.
It provides a clear description of a child's current gross motor function.
Level I can climb stairs without the use of a railing.
Level II can walk in most settings and climb stairs holding onto a railing.
Level III needs usage of a hand held mobility device, may climb stairs holding onto a railing with assistance.
Level IV requires physical assistance or powered mobility in most settings.
Level V children are transported in a manuel wheelchair in all settings, they are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements.
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Eight weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Tugba Kuru Colak, Marmara University Institute of Health Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Acar G, Altun GP, Yurdalan S, Polat MG. Efficacy of neurodevelopmental treatment combined with the Nintendo((R)) Wii in patients with cerebral palsy. J Phys Ther Sci. 2016 Mar;28(3):774-80. doi: 10.1589/jpts.28.774. Epub 2016 Mar 31.
- Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1.
- Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
- Saposnik G, Mamdani M, Bayley M, Thorpe KE, Hall J, Cohen LG, Teasell R; EVREST Steering Committee; EVREST Study Group for the Stroke Outcome Research Canada Working Group. Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system. Int J Stroke. 2010 Feb;5(1):47-51. doi: 10.1111/j.1747-4949.2009.00404.x.
- Shechtman O, Gestewitz L, Kimble C. Reliability and validity of the DynEx dynamometer. J Hand Ther. 2005 Jul-Sep;18(3):339-47. doi: 10.1197/j.jht.2005.04.002.
- James S, Ziviani J, Ware RS, Boyd RN. Relationships between activities of daily living, upper limb function, and visual perception in children and adolescents with unilateral cerebral palsy. Dev Med Child Neurol. 2015 Sep;57(9):852-7. doi: 10.1111/dmcn.12715. Epub 2015 Feb 23.
- Chiu HC, Ada L, Lee HM. Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial. Clin Rehabil. 2014 Oct;28(10):1015-24. doi: 10.1177/0269215514533709. Epub 2014 May 21.
- MacIntosh A, Lam E, Vigneron V, Vignais N, Biddiss E. Biofeedback interventions for individuals with cerebral palsy: a systematic review. Disabil Rehabil. 2019 Oct;41(20):2369-2391. doi: 10.1080/09638288.2018.1468933. Epub 2018 May 12.
- Gilliaux M, Renders A, Dispa D, Holvoet D, Sapin J, Dehez B, Detrembleur C, Lejeune TM, Stoquart G. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial. Neurorehabil Neural Repair. 2015 Feb;29(2):183-92. doi: 10.1177/1545968314541172. Epub 2014 Jul 11.
- Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27.
- Ozdogan H, Ruperto N, Kasapcopur O, Bakkaloglu A, Arisoy N, Ozen S, Ugurlu U, Unsal E, Melikoglu M; Paediatric Rheumatology International Trials Organisation. The Turkish version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ). Clin Exp Rheumatol. 2001 Jul-Aug;19(4 Suppl 23):S158-62.
- Klingels K, De Cock P, Molenaers G, Desloovere K, Huenaerts C, Jaspers E, Feys H. Upper limb motor and sensory impairments in children with hemiplegic cerebral palsy. Can they be measured reliably? Disabil Rehabil. 2010;32(5):409-16. doi: 10.3109/09638280903171469.
- Avery LM, Russell DJ, Raina PS, Walter SD, Rosenbaum PL. Rasch analysis of the Gross Motor Function Measure: validating the assumptions of the Rasch model to create an interval-level measure. Arch Phys Med Rehabil. 2003 May;84(5):697-705. doi: 10.1016/s0003-9993(02)04896-7.
- Yam WK, Leung MS. Interrater reliability of Modified Ashworth Scale and Modified Tardieu Scale in children with spastic cerebral palsy. J Child Neurol. 2006 Dec;21(12):1031-5. doi: 10.1177/7010.2006.00222.
- Hutzler Y, Lamela Rodriguez B, Mendoza Laiz N, Diez I, Barak S. The effects of an exercise training program on hand and wrist strength, and function, and activities of daily living, in adults with severe cerebral palsy. Res Dev Disabil. 2013 Dec;34(12):4343-54. doi: 10.1016/j.ridd.2013.09.015. Epub 2013 Oct 18.
- Klimont L. Principles of Bobath neuro-developmental therapy in cerebral palsy. Ortop Traumatol Rehabil. 2001;3(4):527-30.
- Koman LA, Williams RM, Evans PJ, Richardson R, Naughton MJ, Passmore L, Smith BP. Quantification of upper extremity function and range of motion in children with cerebral palsy. Dev Med Child Neurol. 2008 Dec;50(12):910-7. doi: 10.1111/j.1469-8749.2008.03098.x. Epub 2008 Sep 20.
- Narayanan UG. The role of gait analysis in the orthopaedic management of ambulatory cerebral palsy. Curr Opin Pediatr. 2007 Feb;19(1):38-43. doi: 10.1097/MOP.0b013e3280118a6d.
- Park EY, Kim WH. Effect of neurodevelopmental treatment-based physical therapy on the change of muscle strength, spasticity, and gross motor function in children with spastic cerebral palsy. J Phys Ther Sci. 2017 Jun;29(6):966-969. doi: 10.1589/jpts.29.966. Epub 2017 Jun 7.
- Plautz EJ, Milliken GW, Nudo RJ. Effects of repetitive motor training on movement representations in adult squirrel monkeys: role of use versus learning. Neurobiol Learn Mem. 2000 Jul;74(1):27-55. doi: 10.1006/nlme.1999.3934.
- Ruperto N, Ravelli A, Pistorio A, Malattia C, Cavuto S, Gado-West L, Tortorelli A, Landgraf JM, Singh G, Martini A; Paediatric Rheumatology International Trials Organisation. Cross-cultural adaptation and psychometric evaluation of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ) in 32 countries. Review of the general methodology. Clin Exp Rheumatol. 2001 Jul-Aug;19(4 Suppl 23):S1-9.
- Serdaroglu A, Cansu A, Ozkan S, Tezcan S. Prevalence of cerebral palsy in Turkish children between the ages of 2 and 16 years. Dev Med Child Neurol. 2006 Jun;48(6):413-6. doi: 10.1017/S0012162206000910.
- Spittle AJ, Doyle LW, Boyd RN. A systematic review of the clinimetric properties of neuromotor assessments for preterm infants during the first year of life. Dev Med Child Neurol. 2008 Apr;50(4):254-66. doi: 10.1111/j.1469-8749.2008.02025.x. Epub 2008 Jan 7. Erratum In: Dev Med Child Neurol. 2008 Oct;50(10):800.
- Tesio L, Simone A, Zebellin G, Rota V, Malfitano C, Perucca L. Bimanual dexterity assessment: validation of a revised form of the turning subtest from the Minnesota Dexterity Test. Int J Rehabil Res. 2016 Mar;39(1):57-62. doi: 10.1097/MRR.0000000000000145.
- Tredgett MW, Davis TR. Rapid repeat testing of grip strength for detection of faked hand weakness. J Hand Surg Br. 2000 Aug;25(4):372-5. doi: 10.1054/jhsb.2000.0433.
- Zoccolillo L, Morelli D, Cincotti F, Muzzioli L, Gobbetti T, Paolucci S, Iosa M. Video-game based therapy performed by children with cerebral palsy: a cross-over randomized controlled trial and a cross-sectional quantitative measure of physical activity. Eur J Phys Rehabil Med. 2015 Dec;51(6):669-76. Epub 2015 Feb 5.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. januar 2018
Primær færdiggørelse (Faktiske)
21. maj 2018
Studieafslutning (Faktiske)
1. juni 2018
Datoer for studieregistrering
Først indsendt
27. oktober 2018
Først indsendt, der opfyldte QC-kriterier
29. oktober 2018
Først opslået (Faktiske)
31. oktober 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DilbadeEdRehabCtr
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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