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Clinical Trials/NCT06527469
NCT06527469Enrolling By InvitationNot Applicable

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

University of Missouri-Columbia1 site in 1 country6 target enrollmentStarted: August 19, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
6
Locations
1
Primary Endpoint
Standing balance with eyes closed standing on firm surface

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
7 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

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

Outcomes

Primary Outcomes

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).

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.

Walking- single task

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

Walking speed is obtained form spatial sensor

Walking- cognitive dual task

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

speed of walking will be obtained from spatial sensor while completing appropriate/salient cognitive dual task

Jumping

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

Production of power will be obtained from force plate and spatial sensor

5 Times sit to stand test

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

time to complete and knee joint kinematics obtained from spatial sensor

Step down

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

knee joint kinematics obtained from spatial sensor while the participant steps down from a 6 inch curb step

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).

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)

10 meter walk test

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

Walking speed test of 10 meter distance, completed in both conditions of self selected speed and fast gait speed

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).

Functional measure of how quickly child can climb up and down 1 flight of stairs

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).

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.

Canadian Occupational Performance Measure

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

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.

Reaction time

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

measurement of upper extremity reaching reaction

Keiser Leg Press

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

Assessment of lower extremity power

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).

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.

Lateral Step Ups

Time Frame: Before PT intervention begins (week 1), midpoint of program (Week 7), and last week of program (week 15).

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.

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).

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.

Secondary Outcomes

  • Perspectives of children and caregivers(Completion of program (Week 15))
  • Perspectives of Doctor of Physical Therapy Students(Completion of program (week 15))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jamie Hall

Associate Teaching Professor, Principal Investigator

University of Missouri-Columbia

Study Sites (1)

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