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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Palsy, Myelomeningocele, Arthrogryposis, Motor Skills Disorders, Gross Motor Development Delay

Intervention / Treatment
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* Behavioral: adapted Chicago Run running program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Running group<br>Participants that will join the running program. | Behavioral: adapted Chicago Run running program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 6 min walk test | Participant will walk as far as they can in 6 minutes, as a measure of endurance | baseline | 
| 6 min walk test | Participant will walk as far as they can in 6 minutes, as a measure of endurance | at 8 weeks | 
| 30 second walk test | Participant will walk as fast as they can for 30 seconds, as a measure of speed. | baseline | 
| 30 second walk test | Participant will walk as fast as they can for 30 seconds, as a measure of speed. | at 8 weeks | 
| Resting heart rate | Participant heart rate after 5 minutes of quiet sitting | baseline | 
| Resting heart rate | Participant heart rate after 5 minutes of quiet sitting | at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surveys | Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength | baseline | 
| 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 | 
| 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 | 
| 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 |