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Completed

NCT Number: NCT02643160

Analyzing the Effect of Trunk Training on Limbs in Children With Spastic Cerebral Palsy

The purpose of this study is to analyze if trunk training has effects on trunk, upper, lower extremity motor functions in children with spastic Cerebral Palsy. Second purpose is to analyze the relation between trunk control and prematurity, birth weight, upper and lower extremity motor functions in children with spastic Cerebral Palsy.

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Key information

Conditions

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

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Cerebral Palsy (CP) is a condition caused by a lesion occurred in immature brain during prenatal, natal or postnatal period. Children with CP may have motor, cognitive, sensory, auditory, behavioral problems during their lifespan. Spastic type CP is most common type of CP and many children with spastic CP have both trunk and limb impairment. Physiotherapy is very important for improving motor function and protect from secondary impairments in this children and should start as early as possible. The aim of this study is to analyze if trunk training has effects on trunk, upper and lower extremity motor function in children with spastic CP. 38 children with spastic CP between 4-18 years age are included in this study. Both genders are included. The Participants randomized according to their gross motor function classification system levels and their age. Before intervention all groups assessed with assessment tools which assess muscle spasticity, balance, gross motor function, trunk control and walking characteristics. After randomization there wasn't any intervention for control group; they continued their regular physiotherapy in special education centers two times a week. Study group received trunk training two times a week in addition to their regular physiotherapy in special education centers during 8 weeks. After 8 weeks all groups assessed with the same assessment tools.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with spastic cerebral palsy effected bilaterally
  • Between 4-18 years age

Exclusion criteria

  • Received orthopedic surgery during last 6 weeks
  • Receive Botulinum Toxin injection during last 6 weeks
  • Mentally retarded children with communication limitations
  • Had epileptic seizures during last 12 moths -

Treatment and study plan

Functional Trunk Training

Other

The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region

Primary outcomes

  1. Change in trunk control over time assessed with Trunk Control Measurement Scale.

    Time frame: At baseline and 8 weeks after baseline

    Assessing change in trunk control

Secondary outcomes

  1. Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.

    Time frame: At baseline and 8 weeks after baseline

    Assessment of child's daily living activities and participation

  2. Change in muscle activation over time assessed with Surface Electromyography.

    Time frame: At baseline and 8 weeks after baseline

    Assessment of muscle activation

  3. Change in muscle spasticity over time assessed with Modified Tardieu Scale.

    Time frame: At baseline and 8 weeks after baseline

    Assessing muscle spasticity

  4. Change in gross motor function over time assessed with Gross Motor Function Measurement

    Time frame: At baseline and 8 weeks after baseline

    Assessing gross motor function

  5. Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test

    Time frame: At baseline and 8 weeks after baseline

    Assessing upper extremity skills

  6. Change in loco motion over time assessed with Gillette Functional Assessment Scale

    Time frame: At baseline and 8 weeks after baseline

    Assessing loco motion.

  7. Change in walking parameters over time assessed with Physicians Rating Scale

    Time frame: At baseline and 8 weeks after baseline

    Assessing walking parameters

  8. Change in functional loco motion over time assessed with Timed Up and Go Test

    Time frame: At baseline and 8 weeks after baseline

    Assessing functional loco motion

  9. Change in walking speed over time assessed with 1 Minute Walk Test

    Time frame: At baseline and 8 weeks after baseline

    Assessing walking speed

  10. Change in balance over time assessed with Pediatric Balance Scale

    Time frame: At baseline and 8 weeks after baseline

    Assessing balance

  11. Change in impact of having a disabled child on family over time assessed with Impact on Family Scale

    Time frame: At baseline and 8 weeks after baseline

    Assessing impact on family to have a disabled child

  12. Change in independence level over time assessed with Functional Independence Measure for Kids

    Time frame: At baseline and 8 weeks after baseline

    Assessing independence level

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

Analyzing the Effect of Functional Trunk Training on Upper and Lower Limb Motor Function in Children With Spastic Cerebral Palsy

Acronym: FTT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2015
Registry last updated
Dec 31, 2015

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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