Individualized Assessment of Motor Function and Balance in Intensive Therapy

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05820412
• Other study ID #: 2096274
• Status: Active, not recruiting
• Start date: May 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurodevelopmental Disorders

Intervention

Other:
• Intensive interdisciplinary therapy
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)

Locations

Country	Name	City	State
United States	Children's Therapy Center--MU Healthcare	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Eyes closed standing on firm surface	joint kinematics (movement strategies) obtained while eyes closed standing on firm surface	before physical therapy
Primary	Eyes closed standing on firm surface	joint kinematics (movement strategies) obtained while eyes closed standing on firm surface	immediately following physical therapy
Primary	Eyes closed standing on firm surface	joint kinematics (movement strategies) obtained while eyes closed standing on firm surface	6 weeks following physical therapy
Primary	Eyes closed standing on firm surface	joint kinematics (movement strategies) obtained while eyes closed standing on firm surface	12 weeks following physical therapy
Primary	Walking	speed obtained from spatial sensor	before physical therapy
Primary	Walking	speed obtained from spatial sensor	immediately following physical therapy
Primary	Walking	speed obtained from spatial sensor	6 weeks following physical therapy
Primary	Walking	speed obtained from spatial sensor	12 weeks following
Primary	Walking	stride length obtained from spatial sensor	before physical therapy
Primary	Walking	stride length obtained from spatial sensor	immediately following physical therapy
Primary	Walking	stride length obtained from spatial sensor	6 weeks following physical therapy
Primary	Walking	stride length obtained from spatial sensor	12 weeks following physical therapy
Primary	5 Times sit to stand test	time to complete obtained from spatial sensor	before physical therapy
Primary	5 Times sit to stand test	time to complete obtained from spatial sensor	immediately following physical therapy
Primary	5 Times sit to stand test	time to complete obtained from spatial sensor	6 weeks following physical therapy
Primary	5 Times sit to stand test	time to complete obtained from spatial sensor	12 weeks following physical therapy
Primary	5 Times sit to stand test	knee joint kinematics obtained from spatial sensor	before physical therapy
Primary	5 Times sit to stand test	knee joint kinematics obtained from spatial sensor	immediately following physical therapy
Primary	5 Times sit to stand test	knee joint kinematics obtained from spatial sensor	6 weeks following physical therapy
Primary	5 Times sit to stand test	knee joint kinematics obtained from spatial sensor	12 weeks following physical therapy
Primary	Step down	knee joint kinematics obtained from spatial sensor	before physical therapy
Primary	Step down	knee joint kinematics obtained from spatial sensor	immediately following physical therapy
Primary	Step down	knee joint kinematics obtained from spatial sensor	6 weeks following physical therapy
Primary	Step down	knee joint kinematics obtained from spatial sensor	12 weeks following physical therapy
Secondary	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.	immediately following the episode of care