NCT01585571

Brief Summary

The results of this study will have an impact upon public heath policy as adults with cerebral palsy (CP) present a growing and underserved population in the United States. At the conclusion of this study, we will have identified the means by which the adult with CP maintains their upright position, which is essential for activities of daily living and for movement. With this knowledge, it will be possible to develop clinical and rehabilitation interventions that will improve their arm and leg function, and reduce the risk of falls for the adult with CP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

7.9 years

First QC Date

April 18, 2012

Last Update Submit

February 5, 2020

Conditions

Keywords

BalancePostureVirtual EnvironmentCerebral PalsyAdults

Outcome Measures

Primary Outcomes (1)

  • Center of Mass and Center of Pressure

    The investigators will measure the movement of the subject's center of mass and center of pressure using a force platform while they are looking at different visual scenes and with slow force plate movements.

    4 hours

Secondary Outcomes (3)

  • Muscle activity

    4 hours

  • Movement of the legs and trunk

    4 hours

  • Visual dependence

    1 hour

Study Arms (2)

Control

50 individuals of typical development with no known neuromuscular issues.

Adults with CP

50 Individuals with a pediatric diagnosis of spastic, hemiplegic, diplegic or quadriplegic cerebral palsy.

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The proposed investigation will be a cross-sectional study conducted with adolescents and young adults with typical development, and adolescents and young adults classified as having spastic diplegic or spastic quadriplegic CP between 15 and 30 years of age.

You may qualify if:

  • Individuals with spastic diplegic or quadriplegic CP with the ability to stand for a period of 2 minutes
  • Cognitive/communication skills sufficient to follow multiple step commands and to attend to tasks associated with data collection
  • The control group will consist of age matched adults with no known neurological or somatosensory impairments.
  • Subjects in all groups cannot have a reported sensitivity to motion sickness or visual field deficits or visual problems (lower than 20/40) not corrected by glasses.

You may not qualify if:

  • Abnormal score for vestibular integrity as tested with the Dynamic Illegible 'E'-test
  • Abnormal sensation to light touch and kinesthesia in the foot and ankle as assessed using the monofilament test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University, VEPO Laboratory

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Richard T Lauer, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 26, 2012

Study Start

April 1, 2012

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations