Case Series_Targeted Training for Trunk Control Cerebral Palsy (CP_TT_UHart)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02246751|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2014
Last Update Posted : October 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: Targeted Training for trunk control||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Targeted Training on Sensorimotor Control of Trunk Posture|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
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.
Device: Targeted Training for trunk control
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 Name: Segmental training for trunk control
- Change in sensory motor processes [ Time Frame: 9 months and 1 and 3 months post training ]Change in sensory motor processes as evidenced by kinematic measures during sitting balance perturbation tasks.
- Change in gross motor functional skills (e.g. sitting, crawling, standing) [ Time Frame: 9 months and 1 & 3 months post training ]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 [ Time Frame: 2, 4, 6, 8 and 9 months and 1 & 3 months post training ]Change in the trunk segment where static, active or reactive control is lost.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246751
|United States, Connecticut|
|Pediatric Balance Laboratory; University of Hartford;|
|West Hartford, Connecticut, United States, 06117|
|Principal Investigator:||Sandra Saavedra, MS, PT, PhD||University of Hartford|
|Principal Investigator:||Adam Goodworth, MS, PhD||University of Hartford|