Intensive Pediatric Group Intervention

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: Enrolling by invitation
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: PhysZou emPOWER: a strength, power, and gait intervention group physical therapy program for children with CP

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: Observational
• Enrollment (Estimated): 6

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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)	Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
10 meter walk test	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	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	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	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	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	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)	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	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	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	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	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	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	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	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 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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
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.	Completion of program (Week 15)
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.	Completion of program (Week 15)
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	Completion of program (week 15)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; strength training; physical therapy; group therapy; gait training; power training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID 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