Cerebral PalsyNCT04789746
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
A study testing adapted Chicago Run running program in people with Cerebral Palsy and Myelomeningocele, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Myelomeningocele, Arthrogryposis
- What is being tested?
- adapted Chicago Run running program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2019to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- a medical diagnosis (for example, cerebral palsy) that causes them mobility limitations
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University
Chicago Heights, Illinois, 60611
About this study
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.
- Conditions
- Cerebral Palsy, Myelomeningocele, Arthrogryposis, Motor Skills Disorders, Gross Motor Development Delay
- Being tested
- adapted Chicago Run running program
- Medical subject headings
- Cerebral Palsy, Meningomyelocele, Arthrogryposis, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted Chicago Run running programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Running group | Experimental | Participants that will join the running program. Receives: Behavioral: adapted Chicago Run running program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal attainment scale
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.
Measured: at 8 weeks.
6 min walk test
Participant will walk as far as they can in 6 minutes, as a measure of endurance
Measured: baseline
6 min walk test
Participant will walk as far as they can in 6 minutes, as a measure of endurance
Measured: at 8 weeks
30 second walk test
Participant will walk as fast as they can for 30 seconds, as a measure of speed.
Measured: baseline
30 second walk test
Participant will walk as fast as they can for 30 seconds, as a measure of speed.
Measured: at 8 weeks
Resting heart rate
Participant heart rate after 5 minutes of quiet sitting
Measured: baseline
Resting heart rate
Participant heart rate after 5 minutes of quiet sitting
Measured: at 8 weeks
Secondary outcomes (4)
Surveys
Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength
Measured: baseline
Surveys
Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength
Measured: at 8 weeks
Selective Control Assessment of the Lower Extremity (SCALE)
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
Measured: baseline
Selective Control Assessment of the Lower Extremity (SCALE)
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
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start20 Feb 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Chicago Run, American Academy of Cerebral Palsy and Developmental Medicine
- Responsible party
- Principal investigator, Theresa Moulton, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789746
- Sponsor's protocol ID
- STU00209443
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
- ClinicalTrials.gov ID
- NCT04789746
- Acronym / sponsor ID
- STU00209443
- Conditions
- Cerebral Palsy, Myelomeningocele, Arthrogryposis, Motor Skills Disorders, Gross Motor Development Delay
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Chicago Run, American Academy of Cerebral Palsy and Developmental Medicine
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Running group | Experimental | Behavioral: adapted Chicago Run running programParticipants that will join the running program. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- a medical diagnosis (for example, cerebral palsy) that causes them mobility limitations
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapted Chicago Run running programThe 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. | Behavioural | Running group |
Primary outcome
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.
6 min walk test
Time frame: baseline
Participant will walk as far as they can in 6 minutes, as a measure of endurance
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
30 second walk test
Time frame: baseline
Participant will walk as fast as they can for 30 seconds, as a measure of speed.
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.
Resting heart rate
Time frame: baseline
Participant heart rate after 5 minutes of quiet sitting
Resting heart rate
Time frame: at 8 weeks
Participant heart rate after 5 minutes of quiet sitting
4 secondary outcomes
Surveys
Time frame: baseline
Surveys
Time frame: at 8 weeks
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: baseline
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted Chicago Run running program in people with Cerebral Palsy and Myelomeningocele, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal attainment scale (time frame: at 8 weeks.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.