Intensive Pediatric Group Intervention

February 16, 2026 updated by: Jamie Hall, University of Missouri-Columbia

Intensive Pediatric Group Intervention in a Curricularly-embedded Pro-bono Clinic

The purpose of the Mizzou emPOWER program is to meet the curricular needs of entry-level doctorate of physical therapy students by providing them the real-world experience of implementing recent evidence surrounding physical therapy dosing for children with cerebral palsy (CP) for power, strength, and gait interventions while meeting an unmet community need.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Beginning in Fall 2024, the investigators will recruit 6 children with CP, Gross Motor Function Classification System Levels I-III, ages 7-17 years old, to participate in the program. Two students will be assigned to each participant, rotating every 4 weeks due to the structure of the pro-bono clinic. A total of 3 faculty members will supervise. The group will meet for 2 hours, 2 times per week for 15 weeks. Each session will include a 10-minute game-based warm-up, 45 minutes of gait interventions to include treadmill and overground walking as well as other aerobic activities, 45 minutes of resistance training (power and strength training as appropriate for their individual goals), and a 10-minute cool-down incorporating yoga and breathing activities. Participant assessments will be completed during the first week, 7th week, and 15th week. Other programmatic assessments will include students' written reflections on their experiences providing this program, caregiver satisfaction surveys, and participant and caregiver interviews.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • PhysZou-University of Missouri Department of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ambulatory children aged 7-17 years old with Cerebral Palsy (GMFMCS Levels I-III), participating in PhysZou emPOWER program.

Description

Inclusion Criteria:

  • Ambulatory children 7-17 years old, children who are participating in emPOWER program
  • GMFCS Levels I-III
  • Able to follow 2-3 step directions
  • English Speaking

Exclusion Criteria:

  • Orthopedic surgery in the past year
  • Significant visual impairment
  • Significant hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PhysZou emPOWER
Strength, power, and gait-based intervention for kids with cerebral palsy is embedded within a curricular pro-bono student physical therapy clinic. The group will meet for 2 hours, 2 times per week for 15 weeks.
Other: PhysZou emPOWER: a strength, power, and gait intervention group physical therapy program for children with CP
Each session will include a 10-minute game-based warm-up, 45 minutes of gait interventions to include treadmill and overground walking as well as other aerobic activities, 45 minutes of resistance training (power and strength training as appropriate for their individual goals), and a 10-minute cool-down incorporating yoga and breathing activities. To ensure participants are exercising at the appropriate level of intensity, 1 repetition maximum measures will be used to determine the appropriate levels of resistance and heart rate monitors will be worn.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1 Repetition Maximum (1-RM) Testing
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Particpants will complete strength testing of hip/knee extensors and plantarflexor muscle groups using a leg press, using 1 Rep max testing protocols, as outlined in Pontiff and moreau, 2022. (PMID 35960137)
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
10 meter walk test
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Walking speed test of 10 meter distance, completed in both conditions of self selected speed and fast gait speed
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Keiser Leg Press
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Assessment of lower extremity power
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Timed up and Down Stairs
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Functional measure of how quickly child can climb up and down 1 flight of stairs
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
30 second sit to stands
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
This is a clinical assessment of lower extremity strength, in which investigators count the number of repetitions of sit to stands completed in 30 seconds.
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
30 second half kneel to stand
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
This is a clinical assessment of lower extremity strength, in which investigators count the number of repetitions of half kneel to stand complete correctly in a 30 second time period.
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Lateral Step Ups
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
This is a clinical assessment of lower extremity strength, in which investigators count the number of repetitions of lateral step ups completed in 30 seconds on a standard size 6 inch step.
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
This is a criterion referenced measure of gross motor function and is valid and reliable for children with cerebral palsy. It evaluates motor skills that are typical for normal development. Dimensions D and E will be utilized, as these 2 sections assess the overall gross motor function in direct relation to standing, walking, running, and jumping.
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Canadian Occupational Performance Measure
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Evidence-based outcome measure designed to capture a client's self-perception of performance in goals they determine before intervention. The measurement focuses on self-care, leisure activities, and productivity. The participant rates their performance and their satisfaction with their performance on a scale from 1-10, with 1 indicating poor performance and low satisfaction, while 10 indicates very good performance and high satisfaction.
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Standing balance with eyes closed standing on firm surface
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Participants will stand on a force plate with eyes closed. Postural control information is obtained from the investigators and the force plate tracks the center of pressure of the participant.
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Standing balance with eyes closed standing on firm surface
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Joint kinematics (movement strategies) obtained while eyes closed standing on firm surface
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Walking- single task
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Walking speed is obtained form spatial sensor
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Walking- single task
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Stride length obtained from spatial sensor
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Walking- cognitive dual task
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
speed of walking will be obtained from spatial sensor while completing appropriate/salient cognitive dual task
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Walking- cognitive dual task
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
stride length will be obtained from spatial sensor while completing appropriate/salient cognitive dual task
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
5 Times sit to stand test
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
time to complete and knee joint kinematics obtained from spatial sensor
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Step down
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
knee joint kinematics obtained from spatial sensor while the participant steps down from a 6 inch curb step
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Jumping
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Production of power will be obtained from force plate and spatial sensor
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Jumping
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Assessment of knee joint kinematics during jumping will be obtained from force plate and spatial sensor
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Reaction time
Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measurement of upper extremity reaching reaction
Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perspectives of children and caregivers
Time Frame: Completion of program (Week 15)
Semi-structured interviews will provide researchers with the perspective of the children and caregivers who participated in this novel program.
Completion of program (Week 15)
Perspectives of children and caregivers
Time Frame: Completion of program (Week 15)
Open ended surveys will provide researchers with the perspective of the children and caregivers who participated in this novel program.
Completion of program (Week 15)
Perspectives of Doctor of Physical Therapy Students
Time Frame: Completion of program (week 15)
Open ended surveys will provide researchers and faculty with the perspective of the learning opportunity from the students
Completion of program (week 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2113446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings