Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy
29 ottobre 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Stato
Completato
Condizioni
Condizioni
Descrizione dettagliata
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)'.
Tipo di studio
Tipo di studio
Osservativo
Iscrizione (Effettivo)
Iscrizione
38
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Eyup
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Istanbul, Eyup, Tacchino, 34050
- Dilbade Education and Rehabilitation Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Da 4 anni a 18 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
2
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Range of motion (ROM)
Lasso di tempo: Eight weeks
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Upper extremity ROM measured with universal goniometer.
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Eight weeks
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Spasticity
Lasso di tempo: Eight weeks
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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
Lasso di tempo: Eight weeks
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Grip and pinch strength measured with dynamometer.
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Eight weeks
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Hand Skills
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Eight weeks
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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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Tugba Kuru Colak, Marmara University Institute of Health Sciences
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
8 gennaio 2018
Completamento primario (Effettivo)
Completamento primario
21 maggio 2018
Completamento dello studio (Effettivo)
Completamento dello studio
1 giugno 2018
Date di iscrizione allo studio
Primo inviato
Primo inviato
27 ottobre 2018
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
29 ottobre 2018
Primo Inserito (Effettivo)
Primo Inserito
31 ottobre 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
31 ottobre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 ottobre 2018
Ultimo verificato
Ultimo verificato
1 ottobre 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- DilbadeEdRehabCtr
Piano per i dati dei singoli partecipanti (IPD)
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INDECISO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .