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Completed

NCT Number: NCT03726385

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dilbade Education and Rehabilitation Center

Istanbul, Eyup, 34050, Turkey (Türkiye)

About this study

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)'.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dilara Merve Sarı

Other

Registry information

Official study title

Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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