Case Series_Targeted Training for Trunk Control Cerebral Palsy
CP_TT_UHart
Effect of Targeted Training on Sensorimotor Control of Trunk Posture
1 other identifier
interventional
10
1 country
1
Brief Summary
Little is known about how children with cerebral palsy (CP) use their sensory systems (touch, sense of body position, balance organs in the inner ear, vision) to help them achieve trunk control for independent sitting. If a child with CP does not achieve trunk control by 4 years of age their prognosis for motor skill development including walking is poor. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which children train trunk control in small segments from the top down using a custom fit training device. This study aims to examine how children with moderate to severe CP use sensory information for trunk control before, during and after a program of Targeted Training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
1 active site
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
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedSeptember 7, 2020
September 1, 2020
5.6 years
September 16, 2014
September 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in sensory motor processes
Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.
9 months and 1 and 3 months post training
Secondary Outcomes (2)
Change in gross motor functional skills (e.g. sitting, crawling, standing)
9 months and 1 & 3 months post training
Segmental Assessment of Trunk Control
2, 4, 6, 8 and 9 months and 1 & 3 months post training
Other Outcomes (1)
Participation and Environment Measure for Children and Youth (CY) or Young Children (YC) (PEM-CY for children 5-12 years of age, or YC-PEM for children 2-5 years)
9 months and 3 months post training
Study Arms (1)
Single subject design case series
EXPERIMENTALTargeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day.
Interventions
Orthotics Research and Locomotor Research Unit (ORLAU) standers will be custom fit to help the child train at the segmental level of the trunk where they begin to lose control of posture. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body. The researchers evaluate children every 8 weeks and adjust the stander to lower levels of support as the child gains control.
Eligibility Criteria
You may qualify if:
- cerebral palsy
- age 2-12 years
- Gross Motor Function Classification System (GMFCS) Level III, IV or V
You may not qualify if:
- spinal fixation
- fixed scoliosis
- uncontrolled seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Balance Laboratory; University of Hartford;
West Hartford, Connecticut, 06117, United States
Related Publications (4)
Goodworth AD, Peterka RJ. Sensorimotor integration for multisegmental frontal plane balance control in humans. J Neurophysiol. 2012 Jan;107(1):12-28. doi: 10.1152/jn.00670.2010. Epub 2011 Sep 21.
PMID: 21940611BACKGROUNDGoodworth AD, Peterka RJ. Contribution of sensorimotor integration to spinal stabilization in humans. J Neurophysiol. 2009 Jul;102(1):496-512. doi: 10.1152/jn.00118.2009. Epub 2009 Apr 29.
PMID: 19403751BACKGROUNDSaavedra SL, van Donkelaar P, Woollacott MH. Learning about gravity: segmental assessment of upright control as infants develop independent sitting. J Neurophysiol. 2012 Oct;108(8):2215-29. doi: 10.1152/jn.01193.2011. Epub 2012 Jul 25.
PMID: 22832568BACKGROUNDButler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.
PMID: 20699770BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra Saavedra, MS, PT, PhD
University of Hartford
- PRINCIPAL INVESTIGATOR
Adam Goodworth, MS, PhD
University of Hartford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2014
First Posted
September 23, 2014
Study Start
September 1, 2014
Primary Completion
March 30, 2020
Study Completion
March 30, 2020
Last Updated
September 7, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share