Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy
29 de octubre de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
De observación
Inscripción (Actual)
38
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Eyup
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Istanbul, Eyup, Pavo, 34050
- Dilbade Education and Rehabilitation Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
4 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Range of motion (ROM)
Periodo de tiempo: Eight weeks
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Upper extremity ROM measured with universal goniometer.
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Eight weeks
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Spasticity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Eight weeks
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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
Periodo de tiempo: Eight weeks
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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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Tugba Kuru Colak, Marmara University Institute of Health Sciences
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de enero de 2018
Finalización primaria (Actual)
21 de mayo de 2018
Finalización del estudio (Actual)
1 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
27 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
29 de octubre de 2018
Publicado por primera vez (Actual)
31 de octubre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
29 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DilbadeEdRehabCtr
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .