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Cerebral PalsyNCT06527469

Intensive Pediatric Group Intervention

An observational study of Cerebral Palsy, run by University of Missouri-Columbia at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Cerebral Palsy
What is being tested?
PhysZou emPOWER: a strength, power, and gait intervention group physical therapy program for children with CP
How many people
6 participants
Where
1 siteUnited States
Study dates
19 Aug 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • PhysZou-University of Missouri Department of Physical Therapy

    Columbia, Missouri, 65211

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Cerebral Palsy
Being tested
PhysZou emPOWER: a strength, power, and gait intervention group physical therapy program for children with CP
Keywords
physical therapy, power training, strength training, pediatrics, gait training, group therapy
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhysZou emPOWER: a strength, power, and gait intervention group physical therapy program for children with CPOther

    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.

Study groups in NCT06527469
Study groupRoleWhat they receive
PhysZou emPOWERStrength, 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.
Receives: Other: PhysZou emPOWER: a strength, power, and gait intervention group physical therapy program for children with CP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 Repetition Maximum (1-RM) Testing

    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)

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  2. 10 meter walk test

    Walking speed test of 10 meter distance, completed in both conditions of self selected speed and fast gait speed

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  3. Keiser Leg Press

    Assessment of lower extremity power

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  4. Timed up and Down Stairs

    Functional measure of how quickly child can climb up and down 1 flight of stairs

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  5. 30 second sit to stands

    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.

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  6. 30 second half kneel to stand

    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.

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  7. Lateral Step Ups

    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.

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  8. Gross Motor Function Measure-88 (GMFM-88)

    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.

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  9. Canadian Occupational Performance Measure

    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.

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  10. Standing balance with eyes closed standing on firm surface

    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.

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  11. Standing balance with eyes closed standing on firm surface

    Joint kinematics (movement strategies) obtained while eyes closed standing on firm surface

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  12. Walking- single task

    Walking speed is obtained form spatial sensor

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  13. Walking- single task

    Stride length obtained from spatial sensor

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  14. Walking- cognitive dual task

    speed of walking will be obtained from spatial sensor while completing appropriate/salient cognitive dual task

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  15. Walking- cognitive dual task

    stride length will be obtained from spatial sensor while completing appropriate/salient cognitive dual task

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  16. 5 Times sit to stand test

    time to complete and knee joint kinematics obtained from spatial sensor

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  17. Step down

    knee joint kinematics obtained from spatial sensor while the participant steps down from a 6 inch curb step

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  18. Jumping

    Production of power will be obtained from force plate and spatial sensor

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  19. Jumping

    Assessment of knee joint kinematics during jumping will be obtained from force plate and spatial sensor

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

  20. Reaction time

    measurement of upper extremity reaching reaction

    Measured: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

Secondary outcomes (3)
  1. Perspectives of children and caregivers

    Semi-structured interviews will provide researchers with the perspective of the children and caregivers who participated in this novel program.

    Measured: Completion of program (Week 15)

  2. Perspectives of children and caregivers

    Open ended surveys will provide researchers with the perspective of the children and caregivers who participated in this novel program.

    Measured: Completion of program (Week 15)

  3. Perspectives of Doctor of Physical Therapy Students

    Open ended surveys will provide researchers and faculty with the perspective of the learning opportunity from the students

    Measured: Completion of program (week 15)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start19 Aug 2024
  3. Primary completion31 May 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06527469
Sponsor's protocol ID
2113446
Status last verified
Feb 2026
First submitted
19 Jul 2024
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ambuehl M, van Hedel HJA, Labruyere R. Pediatric Rehabilitation Therapies Differ in Intensity: A Pilot Study to Highlight the Implications for Dose-Response Relationships. Am J Phys Med Rehabil. 2020 Mar;99(3):224-232. doi: 10.1097/PHM.0000000000001323.

    PubMed 31592876
  • Bjornson KF, Moreau N, Bodkin AW. Short-burst interval treadmill training walking capacity and performance in cerebral palsy: a pilot study. Dev Neurorehabil. 2019 Feb;22(2):126-133. doi: 10.1080/17518423.2018.1462270. Epub 2018 Apr 16.

    PubMed 29658831
  • Hedgecock JB, Harris NM, Rapport MJ. Changing Practice: Clinical Application of Resistance Training Evidence for Children With Cerebral Palsy. Pediatr Phys Ther. 2023 Jul 1;35(3):367-376. doi: 10.1097/PEP.0000000000001023.

    PubMed 37289202
  • Oudenhoven LM, van Vulpen LF, Dallmeijer AJ, de Groot S, Buizer AI, van der Krogt MM. Effects of functional power training on gait kinematics in children with cerebral palsy. Gait Posture. 2019 Sep;73:168-172. doi: 10.1016/j.gaitpost.2019.06.023. Epub 2019 Jul 16.

    PubMed 31344605
  • van Vulpen LF, de Groot S, Rameckers E, Becher JG, Dallmeijer AJ. Improved Walking Capacity and Muscle Strength After Functional Power-Training in Young Children With Cerebral Palsy. Neurorehabil Neural Repair. 2017 Sep;31(9):827-841. doi: 10.1177/1545968317723750. Epub 2017 Aug 8.

    PubMed 28786309
  • Pontiff M, Moreau NG. Safety and Feasibility of 1-Repetition Maximum (1-RM) Testing in Children and Adolescents With Bilateral Spastic Cerebral Palsy. Pediatr Phys Ther. 2022 Oct 1;34(4):472-478. doi: 10.1097/PEP.0000000000000941. Epub 2022 Aug 12.

    PubMed 35960137

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06527469, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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