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
1 other identifier
interventional
38
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 25, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedDecember 31, 2015
December 1, 2015
1.7 years
November 25, 2015
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Change in daily living activities and participation over time assessed with Child Health Questionary Parent Form 50.
At baseline and 8 weeks after baseline
Change in muscle activation over time assessed with Surface Electromyography.
At baseline and 8 weeks after baseline
Change in muscle spasticity over time assessed with Modified Tardieu Scale.
At baseline and 8 weeks after baseline
Change in gross motor function over time assessed with Gross Motor Function Measurement
At baseline and 8 weeks after baseline
Change in upper extremity skills over time assessed with Quality of Upper Extremity Skills Test
At baseline and 8 weeks after baseline
- +7 more secondary outcomes
Study Arms (2)
Functional Trunk Training Group
EXPERIMENTALFunctional Trunk Training which includes strengthening of trunk muscle and functional activities including trunk region.
Control Group
NO INTERVENTIONNo intervention, the continued their regular physical therapy
Interventions
The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region
Eligibility Criteria
You may qualify if:
- Children with spastic cerebral palsy effected bilaterally
- Between 4-18 years age
You may not qualify if:
- Received orthopedic surgery during last 6 weeks
- Receive Botulinum Toxin injection during last 6 weeks
- Mentally retarded children with communication limitations
- Had epileptic seizures during last 12 moths -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abant Izzet Baysal Universitylead
- Hacettepe Universitycollaborator
Related 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.ridd.2011.06.012. Epub 2011 Jul 14.
PMID: 21757321RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mintaze KEREM GÜNEL, Professor
Hacettepe University, Graduate School of Health Sciences, Physical Therapy and Rehabilitation Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2015
First Posted
December 31, 2015
Study Start
January 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 31, 2015
Record last verified: 2015-12