NCT05820412

Brief Summary

The goal of this study is to assess the individualized use of technology to assess motor function and balance for ambulatory children participating in an intensive therapy episode of care and determine the effectiveness of the program. Children 7-17 years old who can walk and are completing an intensive therapy episode of care will be recruited to participate in this study. Demographic, health history, and PT,OT,ST medical records will be collected. Based on the participant's functional goals, motor function and balance tests will be selected including common balance tests (standing with eyes open, standing with eyes closed), walking, walking and turning, standing up and sitting down from a bench, reaction time, and step down. Participants will be tested before, immediately after, 6 weeks after, and 12 weeks after the episode of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

March 22, 2023

Last Update Submit

September 10, 2024

Conditions

Neurodevelopmental Disorders

Keywords

technologyneurodevelopmental disorderspediatricsrehabilitationintensive therapy

Outcome Measures

Primary Outcomes (28)

  • Eyes closed standing on firm surface

    center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface

    before physical therapy begins

  • Eyes closed standing on firm surface

    center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface

    immediately following physical therapy

  • Eyes closed standing on firm surface

    center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface

    6 weeks following physical therapy

  • Eyes closed standing on firm surface

    center of pressure as a measure of postural control obtained from a forceplate obtained while eyes closed standing on firm surface

    12 weeks following physical therapy

  • Eyes closed standing on firm surface

    joint kinematics (movement strategies) obtained while eyes closed standing on firm surface

    before physical therapy

  • Eyes closed standing on firm surface

    joint kinematics (movement strategies) obtained while eyes closed standing on firm surface

    immediately following physical therapy

  • Eyes closed standing on firm surface

    joint kinematics (movement strategies) obtained while eyes closed standing on firm surface

    6 weeks following physical therapy

  • Eyes closed standing on firm surface

    joint kinematics (movement strategies) obtained while eyes closed standing on firm surface

    12 weeks following physical therapy

  • Walking

    speed obtained from spatial sensor

    before physical therapy

  • Walking

    speed obtained from spatial sensor

    immediately following physical therapy

  • Walking

    speed obtained from spatial sensor

    6 weeks following physical therapy

  • Walking

    speed obtained from spatial sensor

    12 weeks following

  • Walking

    stride length obtained from spatial sensor

    before physical therapy

  • Walking

    stride length obtained from spatial sensor

    immediately following physical therapy

  • Walking

    stride length obtained from spatial sensor

    6 weeks following physical therapy

  • Walking

    stride length obtained from spatial sensor

    12 weeks following physical therapy

  • 5 Times sit to stand test

    time to complete obtained from spatial sensor

    before physical therapy

  • 5 Times sit to stand test

    time to complete obtained from spatial sensor

    immediately following physical therapy

  • 5 Times sit to stand test

    time to complete obtained from spatial sensor

    6 weeks following physical therapy

  • 5 Times sit to stand test

    time to complete obtained from spatial sensor

    12 weeks following physical therapy

  • 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    before physical therapy

  • 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    immediately following physical therapy

  • 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    6 weeks following physical therapy

  • 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    12 weeks following physical therapy

  • Step down

    knee joint kinematics obtained from spatial sensor

    before physical therapy

  • Step down

    knee joint kinematics obtained from spatial sensor

    immediately following physical therapy

  • Step down

    knee joint kinematics obtained from spatial sensor

    6 weeks following physical therapy

  • Step down

    knee joint kinematics obtained from spatial sensor

    12 weeks following physical therapy

Secondary Outcomes (1)

  • Measures of processes of care

    immediately following the episode of care

Interventions

Intensive interdisciplinary therapyOTHER

Intensive interdisciplinary therapy includes an intense burst of physical, occupational, and/or speech therapy with high intensity and frequency in a duration (e.g. 3-6 hours/day, 3-5 days/week for 4 weeks)

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory children aged 7-17 years old receiving care in an interdisciplinary intensive therapy program.

You may qualify if:

  • Ambulatory children 7-17 years old receiving care in an interdisciplinary, intensive therapy program
  • GMFCS Levels I and II
  • able to follow 2-3 step directions
  • English speaking

You may not qualify if:

  • orthopedic surgery in the past year or
  • significant visual impairment
  • significant hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Therapy Center--MU Healthcare

Columbia, Missouri, 65201, United States

Location

Related Publications (7)

  • Hall JB, Chole D, Pruitt TC, Linkeman K. Caregiver Perceptions of an Interdisciplinary Intensive Therapy Program: A Qualitative Study. Pediatr Phys Ther. 2023 Apr 1;35(2):228-235. doi: 10.1097/PEP.0000000000000994. Epub 2023 Jan 10.

    PMID: 36637445BACKGROUND

  • Guess TM, Bliss R, Hall JB, Kiselica AM. Comparison of Azure Kinect overground gait spatiotemporal parameters to marker based optical motion capture. Gait Posture. 2022 Jul;96:130-136. doi: 10.1016/j.gaitpost.2022.05.021. Epub 2022 May 21.

    PMID: 35635988BACKGROUND

  • Thomas J, Hall JB, Bliss R, Guess TM. Comparison of Azure Kinect and optical retroreflective motion capture for kinematic and spatiotemporal evaluation of the sit-to-stand test. Gait Posture. 2022 May;94:153-159. doi: 10.1016/j.gaitpost.2022.03.011. Epub 2022 Mar 21.

    PMID: 35334335BACKGROUND

  • French MA, Roemmich RT, Daley K, Beier M, Penttinen S, Raghavan P, Searson P, Wegener S, Celnik P. Precision Rehabilitation: Optimizing Function, Adding Value to Health Care. Arch Phys Med Rehabil. 2022 Jun;103(6):1233-1239. doi: 10.1016/j.apmr.2022.01.154. Epub 2022 Feb 15.

    PMID: 35181267BACKGROUND

  • Gannotti ME. Coupling Timing of Interventions With Dose to Optimize Plasticity and Participation in Pediatric Neurologic Populations. Pediatr Phys Ther. 2017 Jul;29 Suppl 3(Suppl 3 IV STEP 2016 CONFERENCE PROCEEDINGS ):S37-S47. doi: 10.1097/PEP.0000000000000383.

    PMID: 28654476BACKGROUND

  • Gannotti ME, Christy JB, Heathcock JC, Kolobe TH. A path model for evaluating dosing parameters for children with cerebral palsy. Phys Ther. 2014 Mar;94(3):411-21. doi: 10.2522/ptj.20130022. Epub 2013 Nov 14.

    PMID: 24231231BACKGROUND

  • Tinderholt Myrhaug H, Ostensjo S, Larun L, Odgaard-Jensen J, Jahnsen R. Intensive training of motor function and functional skills among young children with cerebral palsy: a systematic review and meta-analysis. BMC Pediatr. 2014 Dec 5;14:292. doi: 10.1186/s12887-014-0292-5.

    PMID: 25475608BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Teaching Professor

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 19, 2023

Study Start

May 22, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)