An observational study in Multiple Sclerosis, sponsored by Biogen. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by Biogen · Observational
The primary objective of this feasibility study is to evaluate the functionality (e.g., as defined by the primary endpoints) of the fully integrated Multiple Sclerosis Performance Test (MSPT) device, when used by unsupervised participants with MS, or related conditions, with a broad range of disability, in multi-clinical-care environments. Secondary objectives include: Participant perception of usability of device; Participant satisfaction with the device; Ascertain the impact of different clinical environments on device usability; Ascertain impact of assistive devices in usability of device; Ascertain functionality of Bluetooth remote as compared with manual timing.
This study does not involve evaluation(s) of the clinical efficacy of the MSPT device or the efficacy of MS therapies. This feasibility study is examining the usability of the fully integrated MSPT device. Study participants will be enrolled for same-day testing.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Multiple sclerosis patients or patients with related conditions in a clinical care setting.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Number of study participants successfully completing all modules of the MSPT device
The MSPT software tool builds upon previously validated measures comprising the Multiple Sclerosis Functional Composite (MSFC) that represents a comprehensive functional assessment of MS participants that include: MyHealth: MS -Patient demographic, health and medication information; NeuroQoL - Neurological Quality of Life test -Participant reported; PST Processing Speed Test- Measures mental processing speed; Contrast Sensitivity Test (CST)- 50cm vision test; MDT Manual Dexterity Test- 9 hole peg test; WST Walking Speed Test - Timed 25 foot walk
Time frame: Through study duration (3-4 hours)
Percent (%) of study participants successfully completing all modules of the MSPT device
Time frame: Through study duration (3-4 hours)
Percent (%) of study participants who select agree/strongly agree (questions 1 to 5) or disagree/ strongly disagree (questions 6-9) on appropriate questions on the MSPT Usability Survey
MSPT usability survey is a 10 item paper-based questionnaire to measure participant perception of the usability of the device. A study participant will meet the usability secondary endpoints if usability (agree/strongly agree or disagree/strongly disagree, as appropriate) is selected for 6 or more survey questions.
Time frame: Through study duration (3-4 hours)
Percent (%) of study participants who reported being satisfied or completely satisfied with using MSPT device
MSPT satisfaction survey is a 1 item paper-based questionnaire to measure participant satisfaction with the MSPT device.
Time frame: Through study duration (3-4 hours)
Difference of manual timed versus Bluetooth timed in Walking Speed Test (WST) as assessed by Timed 25 foot walk
T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet.
Time frame: Through study duration (3-4 hours)
The percent (%) of study participants who have usability issues with Bluetooth remote due to use of an assistive device(s)
Time frame: Through study duration (3-4 hours)
Between-site differences in percent (%) of study participants who select agree/strongly agree (questions 1 to 5) or disagree/ strongly disagree (questions 6 to 9) on appropriate questions on the MSPT Usability Survey
Time frame: Through study duration (3-4 hours)
Between-site differences in percent (%) of study participants who select satisfied/completely satisfied on MSPT Satisfaction Survey
Time frame: Through study duration (3-4 hours)
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Biogen