Intensive Pediatric Group Intervention

NCT06527469 | Enrolling By Invitation

• 1 other identifier: 2113446
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 interventions while meeting an unmet community need.

Conditions

Cerebral Palsy

Keywords

physical therapy; power training; strength training; pediatrics; gait training; group therapy

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (3)

• Perspectives of children and caregivers

  Completion of program (Week 15)

• Perspectives of children and caregivers

  Completion of program (Week 15)

• Perspectives of Doctor of Physical Therapy Students

  Completion of program (week 15)

Study Arms (1)

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

Interventions

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.

PhysZou emPOWER

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

PhysZou-University of Missouri Department of Physical Therapy

Columbia, Missouri, 65211, United States

Location

Related Publications (6)

• 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.

  PMID: 31592876 BACKGROUND

• 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.

  PMID: 29658831 BACKGROUND

• 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.

  PMID: 37289202 BACKGROUND

• 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.

  PMID: 31344605 BACKGROUND

• 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.

  PMID: 28786309 BACKGROUND

• 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.

  PMID: 35960137 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Teaching Professor, Principal Investigator

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 30, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)