NCT03441776|Unknown
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Sponsor study identifier
interventional
62
1 country
1
Study Start
February 9, 2018
Actual (reported)Primary Completion
June 2, 2020
Actual (reported)Study Completion
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To prospectively evaluate the tools, environment and resources to compare the effectiveness of two different standard of care vestibular rehabilitation approaches in a military cohort with post-concussive vestibular symptoms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2018
Actual (reported)February 9, 2018
Actual (reported)February 22, 2018
Actual (reported)June 2, 2020
Actual (reported)July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Dizziness Handicap Inventory (DHI) score
Self reported perception of handicap related to dizziness. 25 questions. Each item is scored 0 - 4 (0 = no, 2 = sometimes, 4 = always), yielding a total score between 0 (no perceived disability) and 100 (maximum perceived disability). Subscales related to certain questions are describes as physical, emotional and functional disabilities.
Baseline and 2 weeks after final treatment visit
Change in Activities-specific Balance Confidence (ABC) Scale
Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Sensory Organization Test (SOT)
Baseline and 2 weeks after final treatment visit
Change in Composite Equilibrium Score on Sensory Organization Test (SOT)
Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score on Horizontal Head-Shake Sensory Organization Test (HS-SOT)
Baseline and 2 weeks after final treatment visit
Change in Equilibrium Score Ratio (SOT and Horizontal HS-SOT)
Baseline and 2 weeks after final treatment visit
Randomized Generalized Vestibular Rehabilitation Treatment (8 treatments) as part of standard of care (not research visits)
Randomized Individualized Vestibular Rehabilitation Treatment (3 treatments) as part of standard of care (not research visits)
These treatment visits are available twice a week and each visit lasts 45 minutes. Individuals receiving GVRT are allowed to choose the frequency at which they want to attend and the program is designed for each subject to complete 8 visits within a period between 4 and 8 weeks. The ideal number of patients receiving treatment at each class is from 3 to 6 but the system has capacity for a maximum of 8. GVRT is a standard of care treatment option and is not considered research.
Warrior Recovery Center, Evans Army Community Hospital
Fort Carson, Colorado, 80913, United States
62 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2018
First Posted
February 22, 2018
Study Start
February 9, 2018
VR-based EF Rehabilitation for Pediatric TBI
Individuals receiving IVRT are scheduled depending on their individual needs and PT availability. These visits require one-on-one time with a PT. Individuals are commonly seen by the PT 3 times at two week intervals. These visits last 30 minutes and include PT evaluation designed to instruct patients on exercises for them to perform on their own. IVRT is a standard of care treatment option and is not considered research.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2, 2020
Actual (reported)Study Completion
July 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 24, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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