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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04789746
• Other study ID #: STU00209443
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthrogryposis
• Cerebral Palsy
• Gross Motor Development Delay
• Meningomyelocele
• Motor Skills Disorders
• Myelomeningocele

Intervention

Behavioral:
• adapted Chicago Run running program
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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago Heights	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	American Academy of Cerebral Palsy and Developmental Medicine, Chicago Run, Spencer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 8 weeks.
Primary	6 min walk test	Participant will walk as far as they can in 6 minutes, as a measure of endurance	baseline
Primary	6 min walk test	Participant will walk as far as they can in 6 minutes, as a measure of endurance	at 8 weeks
Primary	30 second walk test	Participant will walk as fast as they can for 30 seconds, as a measure of speed.	baseline
Primary	30 second walk test	Participant will walk as fast as they can for 30 seconds, as a measure of speed.	at 8 weeks
Primary	Resting heart rate	Participant heart rate after 5 minutes of quiet sitting	baseline
Primary	Resting heart rate	Participant heart rate after 5 minutes of quiet sitting	at 8 weeks
Secondary	Surveys	Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength	baseline
Secondary	Surveys	Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength	at 8 weeks
Secondary	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	baseline
Secondary	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	at 8 weeks