Trial · NCT05172466
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 80
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Expanded Disability Status Scale (EDSS) | Week 0 to 4 | The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
| Primary | The Expanded Disability Status Scale (EDSS) | Week 1-6 | The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
| Primary | The Expanded Disability Status Scale (EDSS) | Week 12-18 | The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
| Primary | The Expanded Disability Status Scale (EDSS) | Week 24-32 | The EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems (FS): (1) pyramidal - muscle weakness or difficulty moving limbs;(subscale 0-6); (2) cerebellar - ataxia, loss of balance, coordination or tremor (subscale 0-5); (3) brainstem - problems with speech, swallowing, and nystagmus (subscale 0-5); (4) sensory - numbness or loss of sensations (subscale 0-6); (5) bowel and bladder function subscale (0-5); (6) visual function - problems with sight (subscale 0-6); (7) cerebral functions - problems with thinking and memory (subscale 0-5); (8) other (subscale 0-1). A functional system (FS) represents a network of neurons in the brain with responsibility for particular tasks. The total scale from 1 - 10, with higher score indicting more severe disability. |
| Secondary | Application Based - Timed Up and Go (TUG) | Week 0 to 4 | A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
| Secondary | Application Based - Timed Up and Go (TUG) | Week 1-6 | A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
| Secondary | Application Based - Timed Up and Go (TUG) | Week 12-18 | A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
| Secondary | Application Based - Timed Up and Go (TUG) | Week 24-32 | A validated assessment of functional mobility. The participant is seated in a regular chair with no chair arm-rests. The participant will hold their mobile device in their hand, select the task on the application, and will perform the task without external cue. At the start of the test subjects will stand and walk to a mark three meters from where their feet are placed when sitting, turn 180 degrees, walk back to the chair, and sit to finish. The test result is recorded as the time from start to finish, with a shorter time indicating a lower level of impairment. |
| Secondary | Application Based - Tap Task | Week 0 to 4 | Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
| Secondary | Application Based - Tap Task | Week 1-6 | Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
| Secondary | Application Based - Tap Task | Week 12-18 | Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
| Secondary | Application Based - Tap Task | Week 24-32 | Participants will be presented with a game on their mobile phone that requires them to tap a designated spot as frequently as possible for 10 seconds. The phone will record the number of taps, the regularity of their spacing, and any consistent change over time (fatigue). The test will be repeated 3 times. These measures will be used to make a determination on level of impairment. Higher quantity of taps, more regular spacing, and limited change over time is indicative of a lower level of impairment. |
| Secondary | Application Based - Path Test | Week 0 to 4 | This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
| Secondary | Application Based - Path Test | Week 1-6 | This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
| Secondary | Application Based - Path Test | Week 12-18 | This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
| Secondary | Application Based - Path Test | Week 24-32 | This task asks participants to move an object in the application with their index finger on such that it stays within the boundaries of a moving path. The App will measure deviations outside the path as well as circumstances in which these deviations occur. The test will be repeated 3 times on each side. A lower number of deviations is indicative of a lower level of impairment. |
| Secondary | Application Based - Transcription test | Week 0 to 4 | In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
| Secondary | Application Based - Transcription test | Week 1-6 | In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
| Secondary | Application Based - Transcription test | Week 12-18 | In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
| Secondary | Application Based - Transcription test | Week 24-32 | In this test the subject is given a short auditory phrase and then must type that phrase using a virtual keyboard. The time to complete typing the phrase as well as the time-interval and time-variance between keystrokes is compiled. To control for fine motor function, the virtual keyboard records the time and variance for tapping a series of keys that spontaneously change color (white background to green for example), which is termed the maximal keystroke velocity (strokes/second). A higher maximal keystroke velocity, a lower time-interval, and lower time-variance are associated with a lower level of impairment. |
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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