Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02643160
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Sponsor:
Collaborator:
Hacettepe University
Information provided by (Responsible Party):
Abant Izzet Baysal University

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Other: Functional Trunk Training Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Analyzing the Effect of Functional Trunk Training on Upper and Lower Limb Motor Function in Children With Spastic Cerebral Palsy
Study Start Date : January 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional Trunk Training Group
Functional Trunk Training which includes strengthening of trunk muscle and functional activities including trunk region.
Other: Functional Trunk Training
The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region

No Intervention: Control Group
No intervention, the continued their regular physical therapy



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

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): NCT02643160


Sponsors and Collaborators
Abant Izzet Baysal University
Hacettepe University
Investigators
Layout table for investigator information
Study Director: Mintaze KEREM GÜNEL, Professor Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department
Publications of Results:
Layout table for additonal information
Responsible Party: Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT02643160    
Other Study ID Numbers: GO 14 135
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Keywords provided by Abant Izzet Baysal University:
Trunk Training
Motor Function
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations