Clinical trial NCT06527469: Intensive Pediatric Group Intervention
Official title: Intensive Pediatric Group Intervention in a Curricularly-embedded Pro-bono Clinic
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cerebral Palsy
Keywords: physical therapy
power training
strength training
pediatrics
gait training
group therapy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 6
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: 1 Repetition Maximum (1-RM) Testing
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: 10 meter walk test
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Keiser Leg Press
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Timed up and Down Stairs
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: 30 second sit to stands
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: 30 second half kneel to stand
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Lateral Step Ups
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Canadian Occupational Performance Measure
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Standing balance with eyes closed standing on firm surface
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Standing balance with eyes closed standing on firm surface
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Walking- single task
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Walking- single task
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Walking- cognitive dual task
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Walking- cognitive dual task
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: 5 Times sit to stand test
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Step down
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Jumping
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Jumping
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
measure: Reaction time
timeFrame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).
Secondary outcomes:
measure: Perspectives of children and caregivers
timeFrame: Completion of program (Week 15)
measure: Perspectives of children and caregivers
timeFrame: Completion of program (Week 15)
measure: Perspectives of Doctor of Physical Therapy Students
timeFrame: Completion of program (week 15)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: PhysZou-University of Missouri Department of Physical Therapy
state: Missouri
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.