NCT02246751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

5.6 years

First QC Date

September 16, 2014

Last Update Submit

September 4, 2020

Conditions

Keywords

postural controlTargeted Trainingcerebral palsysensorimotor controltrunk segments

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in gross motor functional skills (e.g. sitting, crawling, standing)

    9 months and 1 & 3 months post training

  • Segmental Assessment of Trunk Control

    2, 4, 6, 8 and 9 months and 1 & 3 months post training

Other Outcomes (1)

  • 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)

    9 months and 3 months post training

Study Arms (1)

Single subject design case series

EXPERIMENTAL

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

Interventions

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.

Also known as: Segmental training for trunk control
Single subject design case series

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • cerebral palsy
  • age 2-12 years
  • Gross Motor Function Classification System (GMFCS) Level III, IV or V

You may not qualify if:

  • spinal fixation
  • fixed scoliosis
  • uncontrolled seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Balance Laboratory; University of Hartford;

West Hartford, Connecticut, 06117, United States

Location

Related Publications (4)

  • Goodworth AD, Peterka RJ. Sensorimotor integration for multisegmental frontal plane balance control in humans. J Neurophysiol. 2012 Jan;107(1):12-28. doi: 10.1152/jn.00670.2010. Epub 2011 Sep 21.

    PMID: 21940611BACKGROUND
  • Goodworth AD, Peterka RJ. Contribution of sensorimotor integration to spinal stabilization in humans. J Neurophysiol. 2009 Jul;102(1):496-512. doi: 10.1152/jn.00118.2009. Epub 2009 Apr 29.

    PMID: 19403751BACKGROUND
  • Saavedra SL, van Donkelaar P, Woollacott MH. Learning about gravity: segmental assessment of upright control as infants develop independent sitting. J Neurophysiol. 2012 Oct;108(8):2215-29. doi: 10.1152/jn.01193.2011. Epub 2012 Jul 25.

    PMID: 22832568BACKGROUND
  • Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.

    PMID: 20699770BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sandra Saavedra, MS, PT, PhD

    University of Hartford

    PRINCIPAL INVESTIGATOR
  • Adam Goodworth, MS, PhD

    University of Hartford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 23, 2014

Study Start

September 1, 2014

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

September 7, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations