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Neurodevelopmental DisordersNCT05820412

Individualized Assessment of Motor Function and Balance in Intensive Therapy

An observational study of Neurodevelopmental Disorders, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Neurodevelopmental Disorders
What is being tested?
Intensive interdisciplinary therapy
How many people
4 participants
Where
1 siteUnited States
Study dates
22 May 2023to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • Child

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Therapy Center--MU Healthcare

    Columbia, Missouri, 65201

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Intensive interdisciplinary therapy
Keywords
technology, neurodevelopmental disorders, pediatrics, rehabilitation, intensive therapy
Medical subject headings
Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: before physical therapy begins

  2. 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

    Measured: immediately following physical therapy

  3. 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

    Measured: 6 weeks following physical therapy

  4. 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

    Measured: 12 weeks following physical therapy

  5. Eyes closed standing on firm surface

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

    Measured: before physical therapy

  6. Eyes closed standing on firm surface

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

    Measured: immediately following physical therapy

  7. Eyes closed standing on firm surface

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

    Measured: 6 weeks following physical therapy

  8. Eyes closed standing on firm surface

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

    Measured: 12 weeks following physical therapy

  9. Walking

    speed obtained from spatial sensor

    Measured: before physical therapy

  10. Walking

    speed obtained from spatial sensor

    Measured: immediately following physical therapy

  11. Walking

    speed obtained from spatial sensor

    Measured: 6 weeks following physical therapy

  12. Walking

    speed obtained from spatial sensor

    Measured: 12 weeks following

  13. Walking

    stride length obtained from spatial sensor

    Measured: before physical therapy

  14. Walking

    stride length obtained from spatial sensor

    Measured: immediately following physical therapy

  15. Walking

    stride length obtained from spatial sensor

    Measured: 6 weeks following physical therapy

  16. Walking

    stride length obtained from spatial sensor

    Measured: 12 weeks following physical therapy

  17. 5 Times sit to stand test

    time to complete obtained from spatial sensor

    Measured: before physical therapy

  18. 5 Times sit to stand test

    time to complete obtained from spatial sensor

    Measured: immediately following physical therapy

  19. 5 Times sit to stand test

    time to complete obtained from spatial sensor

    Measured: 6 weeks following physical therapy

  20. 5 Times sit to stand test

    time to complete obtained from spatial sensor

    Measured: 12 weeks following physical therapy

  21. 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    Measured: before physical therapy

  22. 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    Measured: immediately following physical therapy

  23. 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    Measured: 6 weeks following physical therapy

  24. 5 Times sit to stand test

    knee joint kinematics obtained from spatial sensor

    Measured: 12 weeks following physical therapy

  25. Step down

    knee joint kinematics obtained from spatial sensor

    Measured: before physical therapy

  26. Step down

    knee joint kinematics obtained from spatial sensor

    Measured: immediately following physical therapy

  27. Step down

    knee joint kinematics obtained from spatial sensor

    Measured: 6 weeks following physical therapy

  28. Step down

    knee joint kinematics obtained from spatial sensor

    Measured: 12 weeks following physical therapy

Secondary outcomes (1)

  1. Measures of processes 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.

    Measured: immediately following the episode of care

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start22 May 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820412
Sponsor's protocol ID
2096274
Status last verified
Sep 2024
First submitted
22 Mar 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36637445

  • 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.

    PubMed 35635988

  • 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.

    PubMed 35334335

  • 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.

    PubMed 35181267

  • 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.

    PubMed 28654476

  • 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.

    PubMed 24231231

  • 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.

    PubMed 25475608

Questions about this trial

What is this clinical trial studying?

An observational study of Neurodevelopmental Disorders, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eyes closed standing on firm surface (time frame: before physical therapy begins). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05820412, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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