NCT04789746

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5.8 years

First QC Date

March 3, 2021

Last Update Submit

March 13, 2024

Conditions

Cerebral PalsyMyelomeningoceleArthrogryposisMotor Skills DisordersGross Motor Development Delay

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (4)

  • Surveys

    baseline

  • Surveys

    at 8 weeks

  • Selective Control Assessment of the Lower Extremity (SCALE)

    baseline

  • Selective Control Assessment of the Lower Extremity (SCALE)

    at 8 weeks

Study Arms (1)

Running group

EXPERIMENTAL

Participants that will join the running program.

Behavioral: adapted Chicago Run running program

Interventions

adapted Chicago Run running programBEHAVIORAL

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.

Running group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a medical diagnosis (for example, cerebral palsy) that causes them mobility limitations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago Heights, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cerebral PalsyMeningomyeloceleArthrogryposisMotor Skills Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJoint DiseasesMusculoskeletal DiseasesMuscular DiseasesMusculoskeletal AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 10, 2021

Study Start

February 20, 2019

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

US(1)