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Completed

NCT Number: NCT05820412

Individualized Assessment of Motor Function and Balance in Intensive Therapy

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Therapy Center--MU Healthcare

Columbia, Missouri, 65201, United States

About this study

The goal of this study is to assess the individualized use of instrumented assessment of motor function and balance for ambulatory children participating in an intensive therapy episode of care and determine the effectiveness of the intervention. Children 7-17 with neurodevelopmental diagnosis, GMFCS Levels I and II and 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 in single and dual conditions will be selected including Romberg balance tests, walking, walking and turning, sit to/from stand, reaction time, and step down administered while participant is recorded using a portable measurement platform which incorporates a custom force plate, Azure Kinect spatial sensor, and interface board. Participants will be tested before, immediately after, 6 weeks after, and 12 weeks after the episode of care. Testing is estimated to last for 45 minutes.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Intensive interdisciplinary therapy

Other

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)

Primary outcomes

  1. Eyes closed standing on firm surface

    Time frame: before physical therapy begins

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

  2. Eyes closed standing on firm surface

    Time frame: immediately following physical therapy

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

  3. Eyes closed standing on firm surface

    Time frame: 6 weeks following physical therapy

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

  4. Eyes closed standing on firm surface

    Time frame: 12 weeks following physical therapy

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

  5. Eyes closed standing on firm surface

    Time frame: before physical therapy

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

  6. Eyes closed standing on firm surface

    Time frame: immediately following physical therapy

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

  7. Eyes closed standing on firm surface

    Time frame: 6 weeks following physical therapy

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

  8. Eyes closed standing on firm surface

    Time frame: 12 weeks following physical therapy

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

  9. Walking

    Time frame: before physical therapy

    speed obtained from spatial sensor

  10. Walking

    Time frame: immediately following physical therapy

    speed obtained from spatial sensor

  11. Walking

    Time frame: 6 weeks following physical therapy

    speed obtained from spatial sensor

  12. Walking

    Time frame: 12 weeks following

    speed obtained from spatial sensor

  13. Walking

    Time frame: before physical therapy

    stride length obtained from spatial sensor

  14. Walking

    Time frame: immediately following physical therapy

    stride length obtained from spatial sensor

  15. Walking

    Time frame: 6 weeks following physical therapy

    stride length obtained from spatial sensor

  16. Walking

    Time frame: 12 weeks following physical therapy

    stride length obtained from spatial sensor

  17. 5 Times sit to stand test

    Time frame: before physical therapy

    time to complete obtained from spatial sensor

  18. 5 Times sit to stand test

    Time frame: immediately following physical therapy

    time to complete obtained from spatial sensor

  19. 5 Times sit to stand test

    Time frame: 6 weeks following physical therapy

    time to complete obtained from spatial sensor

  20. 5 Times sit to stand test

    Time frame: 12 weeks following physical therapy

    time to complete obtained from spatial sensor

  21. 5 Times sit to stand test

    Time frame: before physical therapy

    knee joint kinematics obtained from spatial sensor

  22. 5 Times sit to stand test

    Time frame: immediately following physical therapy

    knee joint kinematics obtained from spatial sensor

  23. 5 Times sit to stand test

    Time frame: 6 weeks following physical therapy

    knee joint kinematics obtained from spatial sensor

  24. 5 Times sit to stand test

    Time frame: 12 weeks following physical therapy

    knee joint kinematics obtained from spatial sensor

  25. Step down

    Time frame: before physical therapy

    knee joint kinematics obtained from spatial sensor

  26. Step down

    Time frame: immediately following physical therapy

    knee joint kinematics obtained from spatial sensor

  27. Step down

    Time frame: 6 weeks following physical therapy

    knee joint kinematics obtained from spatial sensor

  28. Step down

    Time frame: 12 weeks following physical therapy

    knee joint kinematics obtained from spatial sensor

Secondary outcomes

  1. Measures of processes of care

    Time frame: immediately following the episode of care

    Questionnaire designed to assess parents' perceptions of the care they and their children receive from children's rehabilitation treatment centres. It is a means to assess family-centred behaviours of health care providers.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Individualized Use of a Multi-dimensional Instrumented Assessment of Motor Function and Balance Following an Intensive Therapy Episode of Care

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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