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

• ClinicalTrials.gov Identifier: NCT02643160
• Recruitment Status: Completed
• First Posted: December 31, 2015
• Last Update Posted: December 31, 2015
• Sponsor: Abant Izzet Baysal University
• Collaborator: Hacettepe University
• Information provided by (Responsible Party): Abant Izzet Baysal University

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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 -

Contacts and Locations

Sponsors and Collaborators

Abant Izzet Baysal University

Hacettepe University

Investigators

• Study Director: Mintaze KEREM GÜNEL, Professor; Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department

More Information

Publications of Results:

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.

• Responsible Party: Abant Izzet Baysal University
• ClinicalTrials.gov Identifier: NCT02643160
• Other Study ID Numbers: GO 14 135
• First Posted: December 31, 2015
• 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:

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