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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cerebral Palsy; Gross Motor Development Delay; Motor Skills Disorders; Myelomeningocele; Arthrogryposis
• Intervention / Treatment: Behavioral: adapted Chicago Run running program

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago Heights, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Running group; Participants that will join the running program.

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Chicago Run; American Academy of Cerebral Palsy and Developmental Medicine; Spencer Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Brain Damage, Chronic; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neurodevelopmental Disorders; Musculoskeletal Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism; Cerebral Palsy; Motor Skills Disorders; Meningomyelocele; Spina Bifida Cystica; Arthrogryposis
• Other Study ID Numbers: STU00209443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No