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Completed Phase 1Phase 2 Interventional

Physical, Functional and Neural Effects of Two Lower Extremity Exercise Protocols in Children With Cerebral Palsy

ClinicalTrials.gov ID: NCT01086670

Public ClinicalTrials.gov record NCT01086670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Physical, Functional and Neural Effects of Two Lower Extremity Exercise Programs in Children With Cerebral Palsy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Background: * Many people who have cerebral palsy (CP) have spastic diplegia, which affects the legs and causes difficulty with leg movement and walking. Research has shown that exercise can help those with CP learn to move their arms better, but more research is needed to determine whether exercise programs can improve leg movements in people with CP. * Walking on a treadmill with the help of a physical therapist has improved the treatment outcomes of some individuals with spinal cord injuries. Many children with CP already have physical therapy but still have trouble with walking and leg coordination. Two other kinds of exercise machines, a stationary bicycle and an elliptical machine, used in the home, may be able to help children with CP walk better and move their legs better. Objectives: * To see how children with cerebral palsy (CP) move their legs differently from children without CP. * To see if an exercise program can improve leg coordination in children with CP. Eligibility: \- Children between 5 and 17 years of age who either have spastic diplegia CP or are healthy volunteers. Design: * Children who are able and willing will have magnetic resonance imaging (MRI) scans at the start and the end of the study. * During Part I of the study, participants will demonstrate their leg and muscle function with the following tests: * Measurement of leg size and movement * Combined camera motion study and electrical impulse evaluation to assess how well the participant walks (with or without an assistive device, as needed) * Leg movement tests on an exercise bicycle and elliptical machine * Tests of leg muscle strength, stiffness, and effectiveness * Ultrasound scans of leg muscle * Parents of participants will complete computer-based questionnaires about their child s motor abilities. * A smaller group of participants will continue to Part II of the study, which involves regular exercise of 20 minutes a day, 5 days a week, for 3 months, on a stationary bicycle or elliptical trainer. Half of the group will start this exercise program immediately after the first part of the study, while the other half will wait 3 months before beginning the exercise program. * During Part II, participants will return to the clinical center for two more sets of the tests and evaluations performed in Part I.

Study identification

NCT ID
NCT01086670
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
55 participants

Conditions and interventions

Eligibility (public fields only)

Age range
5 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 29, 2010
Primary completion
Jan 11, 2015
Completion
May 8, 2016
Last update posted
Mar 28, 2022

2010 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01086670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 28, 2022 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01086670 live on ClinicalTrials.gov.

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