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Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03726385
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dilara Merve Sarı, Dilbade Education and Rehabilitation Center

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.

Condition or disease
Cerebral Palsy

Detailed Description:
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)'.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Official Title: Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Range of motion (ROM) [ Time Frame: Eight weeks ]
    Upper extremity ROM measured with universal goniometer.

  2. Spasticity [ Time Frame: 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.

  3. Grip and pinch strength [ Time Frame: Eight weeks ]
    Grip and pinch strength measured with dynamometer.

  4. Hand Skills [ Time Frame: 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.

  5. Functional Abilities [ Time Frame: 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).

  6. Functional Level [ Time Frame: 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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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726385


Locations
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Turkey
Dilbade Education and Rehabilitation Center
Istanbul, Eyup, Turkey, 34050
Sponsors and Collaborators
Dilara Merve Sarı
Investigators
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Study Director: Tugba Kuru Colak Marmara University Institute of Health Sciences
  Study Documents (Full-Text)

Documents provided by Dilara Merve Sarı, Dilbade Education and Rehabilitation Center:

Additional Information:

Publications:

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Responsible Party: Dilara Merve Sarı, Director of Physiotherapy Department, Dilbade Education and Rehabilitation Center
ClinicalTrials.gov Identifier: NCT03726385     History of Changes
Other Study ID Numbers: DilbadeEdRehabCtr
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilara Merve Sarı, Dilbade Education and Rehabilitation Center:
cerebral palsy
upper extremity rehabilitation
neurodevelopmental therapy
physiotherapy and rehabilitation
visual feedback device
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases