Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02643160
Other study ID # GO 14 135
Secondary ID
Status Completed
Phase N/A
First received November 25, 2015
Last updated December 30, 2015
Start date January 2014
Est. completion date October 2015

Study information

Verified date December 2015
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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 -

Study Design


Intervention

Other:
Functional Trunk Training
The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Abant Izzet Baysal University Hacettepe University

References & Publications (1)

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.rid — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in trunk control over time assessed with Trunk Control Measurement Scale. Assessing change in trunk control At baseline and 8 weeks after baseline
Secondary 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 At baseline and 8 weeks after baseline
Secondary Change in muscle activation over time assessed with Surface Electromyography. Assessment of muscle activation At baseline and 8 weeks after baseline
Secondary Change in muscle spasticity over time assessed with Modified Tardieu Scale. Assessing muscle spasticity At baseline and 8 weeks after baseline
Secondary Change in gross motor function over time assessed with Gross Motor Function Measurement Assessing gross motor function At baseline and 8 weeks after baseline
Secondary Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test Assessing upper extremity skills At baseline and 8 weeks after baseline
Secondary Change in loco motion over time assessed with Gillette Functional Assessment Scale Assessing loco motion. At baseline and 8 weeks after baseline
Secondary Change in walking parameters over time assessed with Physicians Rating Scale Assessing walking parameters At baseline and 8 weeks after baseline
Secondary Change in functional loco motion over time assessed with Timed Up and Go Test Assessing functional loco motion At baseline and 8 weeks after baseline
Secondary Change in walking speed over time assessed with 1 Minute Walk Test Assessing walking speed At baseline and 8 weeks after baseline
Secondary Change in balance over time assessed with Pediatric Balance Scale Assessing balance At baseline and 8 weeks after baseline
Secondary 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 At baseline and 8 weeks after baseline
Secondary Change in independence level over time assessed with Functional Independence Measure for Kids Assessing independence level At baseline and 8 weeks after baseline
See also
  Status Clinical Trial Phase
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Not yet recruiting NCT05131724 - Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy N/A
Completed NCT03005938 - Influence of the Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Cerebral Palsy. N/A
Completed NCT04087330 - Whole-body Vibration in Spastic Hemiplegic Cerebral Palsy N/A
Completed NCT04570358 - Stretching in Children and Adolescents With Spastic Cerebral Palsy N/A
Completed NCT05945953 - Incentive Spirometer as a Visual Feedback in Children With Spastic Cerebral Palsy N/A
Completed NCT03209310 - The Effect of Trunk Control on Respiratory Muscle Strength N/A
Recruiting NCT03361930 - Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk N/A
Recruiting NCT05593887 - Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures N/A
Recruiting NCT03677843 - Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline
Recruiting NCT03179241 - Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition
Not yet recruiting NCT06434246 - Effect of Pully System on Hemiplegic Children N/A
Recruiting NCT05627921 - The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients N/A
Completed NCT05102955 - Turkish Validity and Reliability of the Visual Function Classification System (VFCS)
Recruiting NCT06330922 - Muscle-tendon Pathology and Metabolic Dysregulation in CP
Completed NCT05251519 - The Efficacy of Derotation Banding on Outcome Measures in Children With Cerebral Palsy N/A
Completed NCT05251532 - The Efficacy of Distortion Banding on Outcome Measures in Children With Cerebral Palsy N/A
Completed NCT05115695 - The Effect of Upper Extremity Strengthening on Functionality, Muscle Strength and Trunk in Children With Cerebral Palsy N/A
Completed NCT04240275 - Reliability of a Body-worn Sensor System for Gait Analysis in Children With CP
Not yet recruiting NCT05198921 - The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Spastic Diplegia Cerebral Palsy N/A