Clinical trial NCT05820412: Individualized Assessment of Motor Function and Balance in Intensive Therapy
Official title: Individualized Use of a Multi-dimensional Instrumented Assessment of Motor Function and Balance Following an Intensive Therapy Episode of Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Disorders
Keywords: technology
neurodevelopmental disorders
pediatrics
rehabilitation
intensive therapy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 4
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory children aged 7-17 years old receiving care in an interdisciplinary intensive therapy program.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eyes closed standing on firm surface
timeFrame: before physical therapy begins
measure: Eyes closed standing on firm surface
timeFrame: immediately following physical therapy
measure: Eyes closed standing on firm surface
timeFrame: 6 weeks following physical therapy
measure: Eyes closed standing on firm surface
timeFrame: 12 weeks following physical therapy
measure: Eyes closed standing on firm surface
timeFrame: before physical therapy
measure: Eyes closed standing on firm surface
timeFrame: immediately following physical therapy
measure: Eyes closed standing on firm surface
timeFrame: 6 weeks following physical therapy
measure: Eyes closed standing on firm surface
timeFrame: 12 weeks following physical therapy
measure: Walking
timeFrame: before physical therapy
measure: Walking
timeFrame: immediately following physical therapy
measure: Walking
timeFrame: 6 weeks following physical therapy
measure: Walking
timeFrame: 12 weeks following
measure: Walking
timeFrame: before physical therapy
measure: Walking
timeFrame: immediately following physical therapy
measure: Walking
timeFrame: 6 weeks following physical therapy
measure: Walking
timeFrame: 12 weeks following physical therapy
measure: 5 Times sit to stand test
timeFrame: before physical therapy
measure: 5 Times sit to stand test
timeFrame: immediately following physical therapy
measure: 5 Times sit to stand test
timeFrame: 6 weeks following physical therapy
measure: 5 Times sit to stand test
timeFrame: 12 weeks following physical therapy
measure: 5 Times sit to stand test
timeFrame: before physical therapy
measure: 5 Times sit to stand test
timeFrame: immediately following physical therapy
measure: 5 Times sit to stand test
timeFrame: 6 weeks following physical therapy
measure: 5 Times sit to stand test
timeFrame: 12 weeks following physical therapy
measure: Step down
timeFrame: before physical therapy
measure: Step down
timeFrame: immediately following physical therapy
measure: Step down
timeFrame: 6 weeks following physical therapy
measure: Step down
timeFrame: 12 weeks following physical therapy
Secondary outcomes:
measure: Measures of processes of care
timeFrame: immediately following the episode of care
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Children's Therapy Center--MU Healthcare
state: Missouri
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.