- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246751
Case Series_Targeted Training for Trunk Control Cerebral Palsy (CP_TT_UHart)
Effect of Targeted Training on Sensorimotor Control of Trunk Posture
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the major challenges of motor control is to understand how the central nervous system controls the degrees of freedom of the body. This is particularly evident in cerebral palsy (CP), which is the most prevalent chronic childhood motor disability and is one of the most disabling and costly chronic disorders of children and adults. Deficits in postural control and sensorimotor integration are hallmarks of CP. Although postural control of the trunk for independent sitting creates the foundation for all other motor tasks, surprisingly little is known about how children with CP use sensory input to guide their development of upright control (which occurs in typically developing infants by 8 months of age). This lack of knowledge limits our ability to effectively assess and treat children with neuromotor deficits in trunk control.
The objectives of this project are to identify sensory reliance and sensory re-weighting in a study of children with moderate-to-severe CP (4-12 years of age) before and after Targeted Training for Trunk Control. A novel trunk support device will enable testing of participants who lack (or are still developing) stable sitting. In experiments, kinematics of the head and trunk will be measured. Sensory reliance and re-weighting will be identified from postural trunk responses to sensory conflict stimuli consisting of tilts of a visual surround and/or tilts of a surface which participants sit upon. Generally, participants with a high reliance on vestibular feedback will remain upright with respect to gravity during all tests; whereas a high reliance on cutaneous or visual feedback will produce trunk sway away from upright and toward the surface or visual surround tilt, respectively. To tease apart biomechanical, physical, and neurological contributions to trunk sway, sensorimotor integration modeling will be used to complement data interpretation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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West Hartford, Connecticut, United States, 06117
- Pediatric Balance Laboratory; University of Hartford;
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- cerebral palsy
- age 2-12 years
- Gross Motor Function Classification System (GMFCS) Level III, IV or V
Exclusion Criteria:
- spinal fixation
- fixed scoliosis
- uncontrolled seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single subject design case series
Targeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sensory motor processes
Time Frame: 9 months and 1 and 3 months post training
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Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.
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9 months and 1 and 3 months post training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gross motor functional skills (e.g. sitting, crawling, standing)
Time Frame: 9 months and 1 & 3 months post training
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The Gross Motor Function Measure (GMFM 66) is a standardized test of gross motor function that has been validated for children with cerebral palsy
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9 months and 1 & 3 months post training
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Segmental Assessment of Trunk Control
Time Frame: 2, 4, 6, 8 and 9 months and 1 & 3 months post training
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Change in the trunk segment where static, active or reactive control is lost.
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2, 4, 6, 8 and 9 months and 1 & 3 months post training
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 9 months and 3 months post training
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The PEM-CY and YC-PEM are parent response questionnaires that measure participation frequency, extent of involvement and desire for change in sets of activities typical for the home, school or community.
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9 months and 3 months post training
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandra Saavedra, MS, PT, PhD, University of Hartford
- Principal Investigator: Adam Goodworth, MS, PhD, University of Hartford
Publications and helpful links
General Publications
- Butler 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.
- 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. Erratum In: J Neurophysiol. 2012 Oct;108(8):2338.
- Goodworth 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.
- Saavedra 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP_TT_2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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