Case Series_Targeted Training for Trunk Control Cerebral Palsy

Study Overview
=================
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.

Official Title
-----------------
Effect of Targeted Training on Sensorimotor Control of Trunk Posture

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Device: Targeted Training for trunk control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single subject design case series<br>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<br>* 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.<br>* Other names: Segmental training for trunk control;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 9 months and 1 & 3 months post training | 
| Segmental Assessment of Trunk Control | Change in the trunk segment where static, active or reactive control is lost. | 2, 4, 6, 8 and 9 months and 1 & 3 months post training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postural control, Targeted Training, cerebral palsy, sensorimotor control, trunk segments