Clinical trial NCT02643160: Analyzing the Effect of Trunk Training on Limbs in Children With Spastic Cerebral Palsy
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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Trunk Training
Motor Function
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2015-12-31
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 -

Primary outcomes:
measure: Change in trunk control over time assessed with Trunk Control Measurement Scale.
timeFrame: At baseline and 8 weeks after baseline
Secondary outcomes:
measure: Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.
timeFrame: At baseline and 8 weeks after baseline
measure: Change in muscle activation over time assessed with Surface Electromyography.
timeFrame: At baseline and 8 weeks after baseline
measure: Change in muscle spasticity over time assessed with Modified Tardieu Scale.
timeFrame: At baseline and 8 weeks after baseline
measure: Change in gross motor function over time assessed with Gross Motor Function Measurement
timeFrame: At baseline and 8 weeks after baseline
measure: Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test
timeFrame: At baseline and 8 weeks after baseline
measure: Change in loco motion over time assessed with Gillette Functional Assessment Scale
timeFrame: At baseline and 8 weeks after baseline
measure: Change in walking parameters over time assessed with Physicians Rating Scale
timeFrame: At baseline and 8 weeks after baseline
measure: Change in functional loco motion over time assessed with Timed Up and Go Test
timeFrame: At baseline and 8 weeks after baseline
measure: Change in walking speed over time assessed with 1 Minute Walk Test
timeFrame: At baseline and 8 weeks after baseline
measure: Change in balance over time assessed with Pediatric Balance Scale
timeFrame: At baseline and 8 weeks after baseline
measure: Change in impact of having a disabled child on family over time assessed with Impact on Family Scale
timeFrame: At baseline and 8 weeks after baseline
measure: Change in independence level over time assessed with Functional Independence Measure for Kids
timeFrame: At baseline and 8 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department
name: Mintaze KEREM GÜNEL, Professor
role: STUDY_DIRECTOR
References:
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.