Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy
1 other identifier
observational
38
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedOctober 31, 2018
October 1, 2018
4 months
October 27, 2018
October 29, 2018
Conditions
Keywords
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
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)
Related Publications (26)
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.
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PMID: 12736885BACKGROUNDYam 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: 17156693BACKGROUNDJames 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: 25703777BACKGROUNDGilliaux 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.
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PMID: 25653079BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tugba Kuru Colak
Marmara University Institute of Health Sciences
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