Individualized Assessment of Motor Function and Balance in Intensive Therapy

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05820412
• Collaborator: (none)
• Enrollment: 30
• Anticipated Duration (Months): 19.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurodevelopmental Disorders	Other: Intensive interdisciplinary therapy

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Individualized Use of a Multi-dimensional Instrumented Assessment of Motor Function and Balance Following an Intensive Therapy Episode of Care
• Anticipated Study Start Date: May 22, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Outcome Measures

Primary Outcome Measures

1. Eyes closed standing on firm surface [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 [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 [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 [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 [before physical therapy]

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

6. Eyes closed standing on firm surface [immediately following physical therapy]

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

7. Eyes closed standing on firm surface [6 weeks following physical therapy]

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

8. Eyes closed standing on firm surface [12 weeks following physical therapy]

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

9. Walking [before physical therapy]

   speed obtained from spatial sensor

10. Walking [immediately following physical therapy]

    speed obtained from spatial sensor

11. Walking [6 weeks following physical therapy]

    speed obtained from spatial sensor

12. Walking [12 weeks following]

    speed obtained from spatial sensor

13. Walking [before physical therapy]

    stride length obtained from spatial sensor

14. Walking [immediately following physical therapy]

    stride length obtained from spatial sensor

15. Walking [6 weeks following physical therapy]

    stride length obtained from spatial sensor

16. Walking [12 weeks following physical therapy]

    stride length obtained from spatial sensor

17. 5 Times sit to stand test [before physical therapy]

    time to complete obtained from spatial sensor

18. 5 Times sit to stand test [immediately following physical therapy]

    time to complete obtained from spatial sensor

19. 5 Times sit to stand test [6 weeks following physical therapy]

    time to complete obtained from spatial sensor

20. 5 Times sit to stand test [12 weeks following physical therapy]

    time to complete obtained from spatial sensor

21. 5 Times sit to stand test [before physical therapy]

    knee joint kinematics obtained from spatial sensor

22. 5 Times sit to stand test [immediately following physical therapy]

    knee joint kinematics obtained from spatial sensor

23. 5 Times sit to stand test [6 weeks following physical therapy]

    knee joint kinematics obtained from spatial sensor

24. 5 Times sit to stand test [12 weeks following physical therapy]

    knee joint kinematics obtained from spatial sensor

25. Step down [before physical therapy]

    knee joint kinematics obtained from spatial sensor

26. Step down [immediately following physical therapy]

    knee joint kinematics obtained from spatial sensor

27. Step down [6 weeks following physical therapy]

    knee joint kinematics obtained from spatial sensor

28. Step down [12 weeks following physical therapy]

    knee joint kinematics obtained from spatial sensor

Secondary Outcome Measures

1. Measures of processes of care [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Missouri-Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Jamie Hall, Assistant Teaching Professor, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT05820412
• Other Study ID Numbers: 2096274
• First Posted: Apr 19, 2023
• Last Update Posted: Apr 19, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jamie Hall, Assistant Teaching Professor, University of Missouri-Columbia: technology; neurodevelopmental disorders; pediatrics; rehabilitation; intensive therapy
• Additional relevant MeSH terms: Neurodevelopmental Disorders

Study Results

No Results Posted as of Apr 19, 2023