Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study

NCT01253083 | Completed Phase 1

• 2 other identifiers: 11003711-CC-0037
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury) have shown that it is important to start intensive therapy soon after the injury, and it may be true that starting intensive therapy at a young age will be helpful for children with cerebral palsy. Researchers are interested in testing the effectiveness of a special body weight support system for mobility training in young children who have or are at risk for cerebral palsy. Objectives: \- To study the effectiveness of a mobility training program on the motor skills of young children who have or are at risk for cerebral palsy. Eligibility: \- Children between 12 and 36 months of age who have delayed motor skills and either have been diagnosed with cerebral palsy or show evidence of spasticity or brain damage. Design:

• This study involves two 6-week study phases: a baseline phase and a mobility training program.
• Participants will be screened with a physical examination and medical history.
• During the baseline phase, participants will have mobility testing sessions once every 2 weeks. These tests will measure motor development and ability, including ease and speed of walking.
• Participants' parents/guardians will receive a mobility sensor for the child to wear at home for at least 6 hours (awake time) to measure activity and mobility levels outside of the testing sessions.
• After 6 weeks of baseline testing, participants will have 6 weeks of mobility training for 30 minutes 3 days per week. Training will involve motor tasks with weight support, conducted by a pediatric physical therapist. Activities may include walking, climbing inclines or steps, or squatting to reach toys. All sessions will be videotaped.
• To evaluate the effects of the therapy program, participants will have testing sessions every 2 weeks.
• Parents/guardians will also complete questionnaires to provide feedback on the effectiveness of the therapy program.

Conditions

Developmental Delay; Cerebral Palsy

Keywords

Mobility; Developmental Delay; Cerebral Palsy; Early Walking; Postural Control

Outcome Measures

Primary Outcomes (1)

• Change in motor delay

Secondary Outcomes (1)

• Completion rate, change in gross motor function, change in functional mobility, change in walking speed, change in physical activity

Interventions

mobility training with dynamic body weight support BEHAVIORAL

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• months of age
• greater than or equal to 4 months of gross motor delay corrected for gestational age (measured by Bayley Motor Scale)
• Diagnosis of bilateral spastic cerebral palsy OR neurological evidence of spasticity or brain damage
• Ability to pull to stand at a surface without assistance
• Cognitive ability to follow one-step commands
• Availability to return to NIH CC with parent or caregiver for required treatment and assessment sessions

You may not qualify if:

• Unilateral cerebral palsy
• Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP
• Greater than six months of independent walking experience
• History of surgery or injury to the lower extremities in the past 6 months

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 BACKGROUND

• Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS, Benedict RE, Kirby RS, Durkin MS. Prevalence of cerebral palsy in 8-year-old children in three areas of the United States in 2002: a multisite collaboration. Pediatrics. 2008 Mar;121(3):547-54. doi: 10.1542/peds.2007-1270.

  PMID: 18310204 BACKGROUND

• Odding E, Roebroeck ME, Stam HJ. The epidemiology of cerebral palsy: incidence, impairments and risk factors. Disabil Rehabil. 2006 Feb 28;28(4):183-91. doi: 10.1080/09638280500158422.

  PMID: 16467053 BACKGROUND

MeSH Terms

Conditions

Learning Disabilities; Cerebral Palsy

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Diane L Damiano, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: November 15, 2010
• Primary Completion: June 6, 2014
• Study Completion: June 6, 2014
• Last Updated: December 17, 2019

Record last verified: 2016-04-14

Locations

US (1)