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Completed

NCT Number: NCT02097836

Targeted Training for Trunk Control_case Series Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Training

Device

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.

Primary outcomes

  1. Change in Gross Motor Function Measure

    Time frame: 6 months and followup post training 12 months

  2. Probe data, balance

    Time frame: baseline, intervention, 2 months post intervention

    timed balance task

Secondary outcomes

  1. 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

  2. Change in muscle activation strategy during quiet sitting with different levels of external support.

    Time frame: 6 months, 1 and 3 months post intervention

  3. Change in Pediatric Evaluation of Disability Inventory (PEDI)

    Time frame: 6 months and 1,3, 12 months post intervention

  4. Qualitative Parent, Teacher report

    Time frame: during intervention and post intervention

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Official study title

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

Acronym: CP_TT

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 27, 2014
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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