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Case Series_Targeted Training for Trunk Control Cerebral Palsy (CP_TT_UHart)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Training for trunk control
Sponsored by
University of Hartford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring postural control, Targeted Training, cerebral palsy, sensorimotor control, trunk segments

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pediatric Balance Laboratory; University of Hartford;

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single subject design case series

Arm Description

Targeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day.

Outcomes

Primary Outcome Measures

Change in sensory motor processes
Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.

Secondary Outcome Measures

Change in gross motor functional skills (e.g. sitting, crawling, standing)
The Gross Motor Function Measure (GMFM 66) is a standardized test of gross motor function that has been validated for children with cerebral palsy
Segmental Assessment of Trunk Control
Change in the trunk segment where static, active or reactive control is lost.

Full Information

First Posted
September 16, 2014
Last Updated
September 4, 2020
Sponsor
University of Hartford
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1. Study Identification

Unique Protocol Identification Number
NCT02246751
Brief Title
Case Series_Targeted Training for Trunk Control Cerebral Palsy
Acronym
CP_TT_UHart
Official Title
Effect of Targeted Training on Sensorimotor Control of Trunk Posture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hartford

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
postural control, Targeted Training, cerebral palsy, sensorimotor control, trunk segments

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single subject design case series
Arm Type
Experimental
Arm Description
Targeted Training for trunk control, 5-6 days a week for 9 months, minimum of 20 minutes per day.
Intervention Type
Device
Intervention Name(s)
Targeted Training for trunk control
Other Intervention Name(s)
Segmental training for trunk control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in sensory motor processes
Description
Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.
Time Frame
9 months and 1 and 3 months post training
Secondary Outcome Measure Information:
Title
Change in gross motor functional skills (e.g. sitting, crawling, standing)
Description
The Gross Motor Function Measure (GMFM 66) is a standardized test of gross motor function that has been validated for children with cerebral palsy
Time Frame
9 months and 1 & 3 months post training
Title
Segmental Assessment of Trunk Control
Description
Change in the trunk segment where static, active or reactive control is lost.
Time Frame
2, 4, 6, 8 and 9 months and 1 & 3 months post training
Other Pre-specified Outcome Measures:
Title
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)
Description
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.
Time Frame
9 months and 3 months post training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Saavedra, MS, PT, PhD
Organizational Affiliation
University of Hartford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Goodworth, MS, PhD
Organizational Affiliation
University of Hartford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Balance Laboratory; University of Hartford;
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21940611
Citation
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.
Results Reference
background
PubMed Identifier
19403751
Citation
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.
Results Reference
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PubMed Identifier
22832568
Citation
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.
Results Reference
background
PubMed Identifier
20699770
Citation
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.
Results Reference
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Case Series_Targeted Training for Trunk Control Cerebral Palsy

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