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Enrolling by Invitation

NCT Number: NCT06527469

Intensive Pediatric Group Intervention

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PhysZou-University of Missouri Department of Physical Therapy

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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