Intensive Pediatric Group Intervention

NCT ID: NCT06527469

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2025-02-28

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.

Conditions

Cerebral Palsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jamie Hall

Associate Teaching Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

PhysZou-University of Missouri Department of Physical Therapy

Columbia, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31592876 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29658831 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37289202 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31344605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28786309 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35960137 (View on PubMed)

Other Identifiers

2113446

Identifier Type: -

Identifier Source: org_study_id