search
Back to results

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

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Trunk Training
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Trunk Training, Motor Function

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children with spastic cerebral palsy effected bilaterally
  2. Between 4-18 years age

Exclusion Criteria:

  1. Received orthopedic surgery during last 6 weeks
  2. Receive Botulinum Toxin injection during last 6 weeks
  3. Mentally retarded children with communication limitations
  4. Had epileptic seizures during last 12 moths -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Functional Trunk Training Group

    Control Group

    Arm Description

    Functional Trunk Training which includes strengthening of trunk muscle and functional activities including trunk region.

    No intervention, the continued their regular physical therapy

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.
    Assessment of child's daily living activities and participation
    Change in muscle activation over time assessed with Surface Electromyography.
    Assessment of muscle activation
    Change in muscle spasticity over time assessed with Modified Tardieu Scale.
    Assessing muscle spasticity
    Change in gross motor function over time assessed with Gross Motor Function Measurement
    Assessing gross motor function
    Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test
    Assessing upper extremity skills
    Change in loco motion over time assessed with Gillette Functional Assessment Scale
    Assessing loco motion.
    Change in walking parameters over time assessed with Physicians Rating Scale
    Assessing walking parameters
    Change in functional loco motion over time assessed with Timed Up and Go Test
    Assessing functional loco motion
    Change in walking speed over time assessed with 1 Minute Walk Test
    Assessing walking speed
    Change in balance over time assessed with Pediatric Balance Scale
    Assessing balance
    Change in impact of having a disabled child on family over time assessed with Impact on Family Scale
    Assessing impact on family to have a disabled child
    Change in independence level over time assessed with Functional Independence Measure for Kids
    Assessing independence level

    Full Information

    First Posted
    November 25, 2015
    Last Updated
    December 30, 2015
    Sponsor
    Abant Izzet Baysal University
    Collaborators
    Hacettepe University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02643160
    Brief Title
    Analyzing the Effect of Trunk Training on Limbs in Children With Spastic Cerebral Palsy
    Acronym
    FTT
    Official Title
    Analyzing the Effect of Functional Trunk Training on Upper and Lower Limb Motor Function in Children With Spastic Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abant Izzet Baysal University
    Collaborators
    Hacettepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Spastic
    Keywords
    Trunk Training, Motor Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Functional Trunk Training Group
    Arm Type
    Experimental
    Arm Description
    Functional Trunk Training which includes strengthening of trunk muscle and functional activities including trunk region.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    No intervention, the continued their regular physical therapy
    Intervention Type
    Other
    Intervention Name(s)
    Functional Trunk Training
    Intervention Description
    The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region
    Primary Outcome Measure Information:
    Title
    Change in trunk control over time assessed with Trunk Control Measurement Scale.
    Description
    Assessing change in trunk control
    Time Frame
    At baseline and 8 weeks after baseline
    Secondary Outcome Measure Information:
    Title
    Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.
    Description
    Assessment of child's daily living activities and participation
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in muscle activation over time assessed with Surface Electromyography.
    Description
    Assessment of muscle activation
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in muscle spasticity over time assessed with Modified Tardieu Scale.
    Description
    Assessing muscle spasticity
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in gross motor function over time assessed with Gross Motor Function Measurement
    Description
    Assessing gross motor function
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test
    Description
    Assessing upper extremity skills
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in loco motion over time assessed with Gillette Functional Assessment Scale
    Description
    Assessing loco motion.
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in walking parameters over time assessed with Physicians Rating Scale
    Description
    Assessing walking parameters
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in functional loco motion over time assessed with Timed Up and Go Test
    Description
    Assessing functional loco motion
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in walking speed over time assessed with 1 Minute Walk Test
    Description
    Assessing walking speed
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in balance over time assessed with Pediatric Balance Scale
    Description
    Assessing balance
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in impact of having a disabled child on family over time assessed with Impact on Family Scale
    Description
    Assessing impact on family to have a disabled child
    Time Frame
    At baseline and 8 weeks after baseline
    Title
    Change in independence level over time assessed with Functional Independence Measure for Kids
    Description
    Assessing independence level
    Time Frame
    At baseline and 8 weeks after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mintaze KEREM GÜNEL, Professor
    Organizational Affiliation
    Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21757321
    Citation
    Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs