NCT03726385

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 27, 2018

Last Update Submit

October 29, 2018

Conditions

Keywords

cerebral palsyupper extremity rehabilitationneurodevelopmental therapyphysiotherapy and rehabilitationvisual feedback device

Outcome Measures

Primary Outcomes (6)

  • Range of motion (ROM)

    Upper extremity ROM measured with universal goniometer.

    Eight weeks

  • Spasticity

    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.

    Eight weeks

  • Grip and pinch strength

    Grip and pinch strength measured with dynamometer.

    Eight weeks

  • Hand Skills

    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.

    Eight weeks

  • Functional Abilities

    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).

    Eight weeks

  • Functional Level

    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.

    Eight weeks

Study Arms (2)

Group I

Group I: The control group. Participants in this group received only NDT based upper extremity rehabilitation. Number of the participants were 19.

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.

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilbade Education and Rehabilitation Center

Istanbul, Eyup, 34050, Turkey (Türkiye)

Location

Related Publications (26)

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    PMID: 27134357BACKGROUND
  • 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.

    PMID: 12736885BACKGROUND
  • 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.

    PMID: 17156693BACKGROUND
  • 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.

    PMID: 25703777BACKGROUND
  • 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.

    PMID: 25015650BACKGROUND
  • 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.

    PMID: 24849793BACKGROUND
  • 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.

    PMID: 24145046BACKGROUND
  • Klimont L. Principles of Bobath neuro-developmental therapy in cerebral palsy. Ortop Traumatol Rehabil. 2001;3(4):527-30.

    PMID: 17984909BACKGROUND
  • 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.

    PMID: 20095955BACKGROUND
  • 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.

    PMID: 18811712BACKGROUND
  • 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.

    PMID: 29756481BACKGROUND
  • 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.

    PMID: 17224660BACKGROUND
  • 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.

    PMID: 11510322BACKGROUND
  • 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.

    PMID: 9183258BACKGROUND
  • 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.

    PMID: 28626301BACKGROUND
  • 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.

    PMID: 10873519BACKGROUND
  • 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.

    PMID: 28109566BACKGROUND
  • 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.

    PMID: 18318732BACKGROUND
  • 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.

    PMID: 11510308BACKGROUND
  • 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.

    PMID: 20088994BACKGROUND
  • 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.

    PMID: 16700929BACKGROUND
  • 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.

    PMID: 16059855BACKGROUND
  • 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.

    PMID: 18190538BACKGROUND
  • 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.

    PMID: 26579699BACKGROUND
  • 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.

    PMID: 11058007BACKGROUND
  • 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.

    PMID: 25653079BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Tugba Kuru Colak

    Marmara University Institute of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Physiotherapy Department

Study Record Dates

First Submitted

October 27, 2018

First Posted

October 31, 2018

Study Start

January 8, 2018

Primary Completion

May 21, 2018

Study Completion

June 1, 2018

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations