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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02097836
Other study ID # CP_TT_2008
Secondary ID
Status Completed
Phase N/A
First received March 24, 2014
Last updated September 12, 2017
Start date September 2007
Est. completion date January 2010

Study information

Verified date September 2017
Source University of Oregon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

If a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. Surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. This is one of the first studies that will examine intermediate stages in the development of the postural control system in children with neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which trunk control is trained in children segment by segment using a specific training device. This study aims to examine kinematic and electromyographic changes in a case series of children who undergo a 6-month Targeted Training intervention.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date January 2010
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria:

- neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury)

- age 4-17 years

- Gross Motor Function Classification System (GMFCS) level III, IV or V for children with cerebral palsy

Exclusion Criteria:

- spinal fixation

- fixed scoliosis

- uncontrolled seizures

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Targeted Training
Custom training devices were imported from The Movement Centre for research purposes. 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Oregon

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Gross Motor Function Measure 6 months and followup post training 12 months
Primary Probe data, balance timed balance task baseline, intervention, 2 months post intervention
Secondary Change in head stability Change in alignment and stability of head postural sway during quiet sitting 6 months, 1,3, and 12 months post intervention
Secondary Change in muscle activation strategy during quiet sitting with different levels of external support. 6 months, 1 and 3 months post intervention
Secondary Change in Pediatric Evaluation of Disability Inventory (PEDI) 6 months and 1,3, 12 months post intervention
Secondary Qualitative Parent, Teacher report during intervention and post intervention
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