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OpenTrials
Enrolling by invitation

NCT Number: NCT04789746

Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges

Barriers to keeping and maintaining fitness as a young person with a disability exist across many domains of access to community locations such as fitness centers, so looking outside of these establishments may be necessary to advance fitness. This study is aimed at piloting a program that would address some of these barriers by hosting a modified after school running program with an underserved population in an accessible way. There is a second option to participate outside of school.

Enrolling by invitation

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Key information

Conditions

Cerebral Palsy Arthrogryposis Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gross Motor Development Delay Joint Diseases Meningomyelocele Mental Disorders Motor Skills Disorders Muscular Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Myelomeningocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago Heights, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a medical diagnosis (for example, cerebral palsy) that causes them mobility limitations

Exclusion criteria

  • concurrent medical condition that would make exercise unsafe,
  • are unable to follow simple commands
  • have behaviors that would potentially compromise safety of fellow runners or caregivers

Treatment and study plan

adapted Chicago Run running program

Behavioral

The intervention being piloted is a 6-8 week running program modified from a running curriculum designed for school-aged children. The children will use a RaceRunner device to facilitate their participation, but this device is not explicitly evaluated in this study. Depending on transportation, they may be given access to the device in their home or school between sessions after it has been fit for them. If given access, guardians will be instructed on care and usage.

Primary outcomes

  1. Goal attainment scale

    Time frame: at 8 weeks.

    a tool designed to standardize the setting and scaling of goals in a way that allows for both improvement and regression as a result of intervention.

  2. 6 min walk test

    Time frame: baseline

    Participant will walk as far as they can in 6 minutes, as a measure of endurance

  3. 6 min walk test

    Time frame: at 8 weeks

    Participant will walk as far as they can in 6 minutes, as a measure of endurance

  4. 30 second walk test

    Time frame: baseline

    Participant will walk as fast as they can for 30 seconds, as a measure of speed.

  5. 30 second walk test

    Time frame: at 8 weeks

    Participant will walk as fast as they can for 30 seconds, as a measure of speed.

  6. Resting heart rate

    Time frame: baseline

    Participant heart rate after 5 minutes of quiet sitting

  7. Resting heart rate

    Time frame: at 8 weeks

    Participant heart rate after 5 minutes of quiet sitting

Secondary outcomes

  1. Surveys

    Time frame: baseline

    Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength

  2. Surveys

    Time frame: at 8 weeks

    Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength

  3. Selective Control Assessment of the Lower Extremity (SCALE)

    Time frame: baseline

    a method of assessing the ability of a participant to isolate motion to an individual joint of the lower extremity. Min score=0; max score=16, a higher score is a better outcome

  4. Selective Control Assessment of the Lower Extremity (SCALE)

    Time frame: at 8 weeks

    a method of assessing the ability of a participant to isolate motion to an individual joint of the lower extremity Min score=0; max score=16, a higher score is a better outcome

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • American Academy of Cerebral Palsy and Developmental Medicine
  • Chicago Run

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Mar 10, 2021
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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