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

Primary Purpose

Cerebral Palsy, Myelomeningocele, Arthrogryposis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
adapted Chicago Run running program
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Running group

Arm Description

Participants that will join the running program.

Outcomes

Primary Outcome Measures

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.
6 min walk test
Participant will walk as far as they can in 6 minutes, as a measure of endurance
6 min walk test
Participant will walk as far as they can in 6 minutes, as a measure of endurance
30 second walk test
Participant will walk as fast as they can for 30 seconds, as a measure of speed.
30 second walk test
Participant will walk as fast as they can for 30 seconds, as a measure of speed.
Resting heart rate
Participant heart rate after 5 minutes of quiet sitting
Resting heart rate
Participant heart rate after 5 minutes of quiet sitting

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2021
Last Updated
February 8, 2023
Sponsor
Northwestern University
Collaborators
Chicago Run, American Academy of Cerebral Palsy and Developmental Medicine, Spencer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04789746
Brief Title
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Official Title
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Chicago Run, American Academy of Cerebral Palsy and Developmental Medicine, Spencer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Myelomeningocele, Arthrogryposis, Motor Skills Disorders, Gross Motor Development Delay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Running group
Arm Type
Experimental
Arm Description
Participants that will join the running program.
Intervention Type
Behavioral
Intervention Name(s)
adapted Chicago Run running program
Intervention Description
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 Outcome Measure Information:
Title
Goal attainment scale
Description
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.
Time Frame
at 8 weeks.
Title
6 min walk test
Description
Participant will walk as far as they can in 6 minutes, as a measure of endurance
Time Frame
baseline
Title
6 min walk test
Description
Participant will walk as far as they can in 6 minutes, as a measure of endurance
Time Frame
at 8 weeks
Title
30 second walk test
Description
Participant will walk as fast as they can for 30 seconds, as a measure of speed.
Time Frame
baseline
Title
30 second walk test
Description
Participant will walk as fast as they can for 30 seconds, as a measure of speed.
Time Frame
at 8 weeks
Title
Resting heart rate
Description
Participant heart rate after 5 minutes of quiet sitting
Time Frame
baseline
Title
Resting heart rate
Description
Participant heart rate after 5 minutes of quiet sitting
Time Frame
at 8 weeks
Secondary Outcome Measure Information:
Title
Surveys
Description
Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength
Time Frame
baseline
Title
Surveys
Description
Participants and their parents will answer questions about baseline level of activity, their perception of themselves, and areas of personal strength
Time Frame
at 8 weeks
Title
Selective Control Assessment of the Lower Extremity (SCALE)
Description
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
Time Frame
baseline
Title
Selective Control Assessment of the Lower Extremity (SCALE)
Description
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
Time Frame
at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Northwestern University
City
Chicago Heights
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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