Targeted Training for Trunk Control_case Series Cerebral Palsy (CP_TT)

September 12, 2017 updated by: University of Oregon

Segmental Training for Trunk Control a Pilot Study for Children With Moderate to Severe Motor Impairment.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single subject case series
Targeted training, 5-6 days a week for 6 months, minimum of 20 minutes per day
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gross Motor Function Measure
Time Frame: 6 months and followup post training 12 months
6 months and followup post training 12 months
Probe data, balance
Time Frame: baseline, intervention, 2 months post intervention
timed balance task
baseline, intervention, 2 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in head stability
Time Frame: 6 months, 1,3, and 12 months post intervention
Change in alignment and stability of head postural sway during quiet sitting
6 months, 1,3, and 12 months post intervention
Change in muscle activation strategy during quiet sitting with different levels of external support.
Time Frame: 6 months, 1 and 3 months post intervention
6 months, 1 and 3 months post intervention
Change in Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: 6 months and 1,3, 12 months post intervention
6 months and 1,3, 12 months post intervention
Qualitative Parent, Teacher report
Time Frame: during intervention and post intervention
during intervention and post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oregon

Investigators

  • Principal Investigator: Sandra L Saavedra, PhD, University of Oregon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP_TT_2008

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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