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

Analyzing the Effect of Functional Trunk Training on Upper and Lower Limb Motor Function 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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Functional Trunk Training

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in muscle activation over time assessed with Surface Electromyography.	Assessment of muscle activation	At baseline and 8 weeks after baseline
Change in muscle spasticity over time assessed with Modified Tardieu Scale.	Assessing muscle spasticity	At baseline and 8 weeks after baseline
Change in gross motor function over time assessed with Gross Motor Function Measurement	Assessing gross motor function	At baseline and 8 weeks after baseline
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
Change in loco motion over time assessed with Gillette Functional Assessment Scale	Assessing loco motion.	At baseline and 8 weeks after baseline
Change in walking parameters over time assessed with Physicians Rating Scale	Assessing walking parameters	At baseline and 8 weeks after baseline
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
Change in walking speed over time assessed with 1 Minute Walk Test	Assessing walking speed	At baseline and 8 weeks after baseline
Change in balance over time assessed with Pediatric Balance Scale	Assessing balance	At baseline and 8 weeks after baseline
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
Change in independence level over time assessed with Functional Independence Measure for Kids	Assessing independence level	At baseline and 8 weeks after baseline

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University
• Collaborators: Hacettepe University
• Investigators: Study Director: Mintaze KEREM GÜNEL, Professor, Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 30, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Motor Function; Trunk Training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: GO 14 135