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Enrolling by invitation NCT06527469

Intensive Pediatric Group Intervention

— Observational Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PhysZou emPOWER: a strength, power, and gait intervention group physical therapy program for children with CP.
Who it may be relevant to
Registry conditions: Cerebral Palsy. Basic parameters: 7 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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 l

Primary outcome measures

  • 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).]
  • 10 meter walk test [Time frame: 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).]
  • 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).]
  • 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).]
  • 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).]
  • Lateral Step Ups [Time frame: 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).]
  • Canadian Occupational Performance Measure [Time frame: 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).]
Secondary outcome measures (3)
  • Perspectives of children and caregivers [Time frame: Completion of program (Week 15)]
  • Perspectives of children and caregivers [Time frame: Completion of program (Week 15)]
  • Perspectives of Doctor of Physical Therapy Students [Time frame: Completion of program (week 15)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • PhysZou-University of Missouri Department of Physical Therapy — Columbia

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35960137

Identifiers

NCT: NCT06527469 · 2113446

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗