Trial · NCT04588207
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study | 9 months | Number and percentage of participants who met inclusion/exclusion criteria and were enrolled in the study. To be assessed by analysis of enrollment data. |
| Primary | Number and Percentage of Participants Enrolled Who Completed the Study | 9 months | Number and percentage of participants enrolled who completed the study. To be assessed by analysis of enrollment and completion data. |
| Primary | Monthly Enrollment Rate | 9 months | Number of participants enrolled in the study every month. To be assessed by analysis of enrollment data |
| Primary | Number of Prescribed Urea Doses Taken by Participants | Baseline to day 42 while taking urea | Number of prescribed urea doses taken by participants. To be assessed by records in study diary and number of returned medication doses. |
| Primary | Reasons for Non-Adherence to Urea Therapy | Baseline to day 42 while taking urea | Reasons for non-adherence to urea therapy. To be assessed by medication acceptability and medication side effect questionnaires |
| Primary | Change in Plasma Sodium Concentration | Baseline to day 42 | Change in plasma sodium concentration from baseline to day 42. Based on plasma sodium assessments on days 0 and 42. |
| Primary | Change in Percentage Accuracy Action Boundary Selection | Baseline to day 42 | Change in percentage accuracy action boundary selection from baseline to day 42. This will be measured by the Perception-Action Coupling Task (PACT) which is an affordance-based assessment conducted on an iPad, which uses matched pairs of 'virtual' balls and 'virtual' holes to assess patients' ability to accurately assess their action boundaries. Accuracy of affordance perception is measured. Scores goes from 0% to 100% with higher score representing increased accuracy |
| Primary | Change in Overall Score of Sensorimotor Ability Battery | Baseline to day 42 | Change in overall score of sensorimotor ability battery from baseline to day 42. This will be measured by the Senaptec Sensory Station™ test battery which examines separate sensorimotor elements including; multiple object tracking, reaction time, perception span, go/no go, depth perception and dynamic visual acuity. Score goes from 0 to1500 with higher scores representing better sensorimotor ability |
| Primary | Change in the Sample Entropy of the Center of Pressure Data From the Force Plate | Baseline to day 42 | Measure the 'structure' of the noise in the oscillations of the center of mass of the individual. The measurement represent the percentage of displacement from the center of pressure. No reference ranges are available as these vary according to the population studied |
| Primary | Change in Percentage Angular Deviation of Vestibular Control System Using Dynamic Representation of Upright Stance | Baseline to day 42 | Change in percentage angular deviation of vestibular control system using dynamic representation of upright stance from baseline to day 42. This was assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the vestibular control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the vestibular system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in vestibular balance control. |
| Primary | Change in Percentage Angular Deviation of Somatosensory Control System Using Dynamic Representation of Upright Stance | Baseline to day 42 | Change in percentage angular deviation of somatosensory control system using dynamic representation of upright stance from baseline to day 42. This will be assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the somatosensory control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the somatosensory system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in somatosensory balance control. |
| Primary | Change in Percentage Angular Deviation of Visual Control System Using Dynamic Representation of Upright Stance | Baseline to 42 days | Change in percentage angular deviation of visual control system using dynamic representation of upright stance from baseline to day 42. This will be assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the visual control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the visual system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in visual balance control. |
| Primary | Change in Percentage Weight Symmetry Using Dynamic Representation of Upright Stance | Baseline to day 42 | Change in percentage weight symmetry using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. Weight symmetry indicates weight distribution under the left and right legs prior to perturbation onset. A score of 100 indicates perfect between-limb symmetry. Larger deviations away (higher or Lower) from 100 indicate asymmetry. Scores goes from -100 to +100 closer to 100 is optimal. |
| Primary | Change in Movement Latency of Posture Control and Stability Using Dynamic Representation of Upright Stance | Baseline to day 42 | Change in movement latency of posture control and stability using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. Latency scores measure the time lapse between force plate translation on postural response for healthy, elderly populations, with previously reported mean latency values ranging from 126.80-131.40. Higher/Larger scores indicate poorer balance control. |
| Primary | Change in Amplitude Scaling of Posture Control and Stability Using Dynamic Representation of Upright Stance | Baseline to day 42 | Change in amplitude scaling of posture control and stability using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. It is scored in units of angular momentum and normalized to body height and weight. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in ability to recover from an unexpected external translation reflecting better balance. |
| Primary | Number and Proportion of Participants Enrolled in the Study With Adverse Events Related to the Use of Urea | Baseline to day 42 while taking urea | Number and proportion of participants enrolled in the study with adverse events related to the use of urea from baseline to day 42. To be assessed by medication side effect questionnaire. |
| Primary | Adverse Events Related to Urea | Baseline to day 42 while taking urea | To be assessed by medication side effect questionnaire. A tabulation of counts of participants experiencing specific known side effects of urea as well as their intensity (mild, moderate or severe) will be performed. |
| Secondary | Number of Patients Screened | 9 months | Number of patients screened. To be assessed by analysis of screening data. |
| Secondary | Number and Percentage of Patients Screened Who Met Inclusion/Exclusion Criteria for the Study | 9 months | Number and percentage of patients screened who met inclusion/exclusion criteria for the study. To be assessed by analysis of screening and enrollment data. |
| Secondary | Number and Proportion of Participants Who Took More Than 80 Percent of Prescribed Urea Doses | Baseline to day 42 while taking urea | Number and proportion of participants who took more than 80 percent of prescribed urea doses. To be assessed by analysis of study diary and number of returned medication doses. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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