NCT00268931

Brief Summary

The specific purpose of this study is to determine the effect of movement training on the onset of motor skills in babies born prematurely. We hypothesize that infants who participate in movement training will show advances in motor skills, visual attention, and toy-oriented behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

Enrollment Period

3.7 years

First QC Date

December 21, 2005

Last Update Submit

April 12, 2013

Conditions

Premature Birth

Keywords

premature birthmotor skillslearningreaching

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is to evaluate the effectiveness of movement training in preterm babies. This will be measured by number of toy contacts, hand/foot-toy distance, duration of toy contact, and duration of visual attention.

    8 weeks

Study Arms (3)

True Control

NO INTERVENTION

This group is being enrolled as a true control group. This group will not participate in the movement training or social training however, they will be evaluated in the same way.

Social Training

EXPERIMENTAL

This group underwent specific social interactions two times each day with their parents.

Behavioral: Social Training

Movement Training

EXPERIMENTAL

This group of preterm infants underwent movement training two times per day with their parents.

Behavioral: Movement Training

Interventions

Movement TrainingBEHAVIORAL

This group of infants underwent specific movement training activities two times per day with their parents.

Movement Training
Social TrainingBEHAVIORAL

This group underwent special social interactions with their parents two times each day.

Social Training

Eligibility Criteria

Age6 Weeks - 11 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants born less than 33 weeks gestation (up to and including 32 6/7 weeks)
  • Infants born weighing less than 2500 grams

You may not qualify if:

  • Orthopedic, visual or hearing impairments
  • Fetal drug exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Systems

Newark, Delaware, 19718, United States

Location

Related Publications (6)

  • Fagen JW, Morrongiello BA, Rovee-Collier C, Gekoski MJ. Expectancies and memory retrieval in three-month-old infants. Child Dev. 1984 Jun;55(3):936-43.

    PMID: 6734328BACKGROUND

  • Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The relative kicking frequency of infants born full-term and preterm during learning and short-term and long-term memory periods of the mobile paradigm. Phys Ther. 2005 Jan;85(1):8-18.

    PMID: 15623358BACKGROUND

  • Heathcock JC, Bhat AN, Lobo MA, Galloway JC. The performance of infants born preterm and full-term in the mobile paradigm: learning and memory. Phys Ther. 2004 Sep;84(9):808-21.

    PMID: 15330694BACKGROUND

  • Cherkes-Julkowski M. Learning disability, attention-deficit disorder, and language impairment as outcomes of prematurity: a longitudinal descriptive study. J Learn Disabil. 1998 May-Jun;31(3):294-306. doi: 10.1177/002221949803100309.

    PMID: 9599962BACKGROUND

  • de Vries AM, de Groot L. Transient dystonias revisited: a comparative study of preterm and term children at 2 1/2 years of age. Dev Med Child Neurol. 2002 Jun;44(6):415-21. doi: 10.1017/s0012162201002298.

    PMID: 12088310BACKGROUND

  • Angulo-Kinzler RM, Ulrich B, Thelen E. Three-month-old infants can select specific leg motor solutions. Motor Control. 2002 Jan;6(1):52-68. doi: 10.1123/mcj.6.1.52.

    PMID: 11842270BACKGROUND

Related Links

MeSH Terms

Conditions

Premature Birth

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Jill C. Heathcock, MPT

    University of Delaware

    PRINCIPAL INVESTIGATOR

  • James C Galloway, Ph.D.

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

August 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

US(1)