MSPT Device Usability Study
MSPT
The Multiple Sclerosis Performance Test (MSPT) Device for Functional Assessment of Multiple Sclerosis (MS) Patients
1 other identifier
observational
60
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2016
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 4, 2016
April 1, 2016
1 month
December 10, 2015
May 2, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
Through study duration (3-4 hours)
Percent (%) of study participants successfully completing all modules of the MSPT device
Through study duration (3-4 hours)
Secondary Outcomes (6)
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
Through study duration (3-4 hours)
Percent (%) of study participants who reported being satisfied or completely satisfied with using MSPT device
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
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)
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
Through study duration (3-4 hours)
- +1 more secondary outcomes
Eligibility Criteria
Multiple sclerosis patients or patients with related conditions in a clinical care setting.
You may qualify if:
- Diagnosis of MS, or related conditions, such as: Clinically Isolated Syndrome (CIS), Neuromyelitis Optica (NMO), and Transverse Myelitis (TM)
- Literacy of written English language as displayed on software tool
- Ability to understand and comprehend software tool from the audio and visual instructions provided in English
You may not qualify if:
- Study participants, who in the opinion of the Investigator, have vision impairment that precludes their ability to see the iPad Air2® screen/MSPT device.
- Neurological illnesses/conditions, such as motor or vocal tics (including a diagnosis of Tourette's syndrome), head trauma with significant loss of consciousness (\>30 minutes), cerebral palsy, dementia (including mild cognitive impairment and Alzheimer's disease), chronic meningitis, Parkinson's disease, and Huntington's disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (3)
Research Site
Baltimore, Maryland, 21287, United States
Research Site
New York, New York, 10016, United States
Research Site
Cleveland, Ohio, 44195, United States
Related Publications (1)
Rhodes JK, Schindler D, Rao SM, Venegas F, Bruzik ET, Gabel W, Williams JR, Phillips GA, Mullen CC, Freiburger JL, Mourany L, Reece C, Miller DM, Bethoux F, Bermel RA, Krupp LB, Mowry EM, Alberts J, Rudick RA. Multiple Sclerosis Performance Test: Technical Development and Usability. Adv Ther. 2019 Jul;36(7):1741-1755. doi: 10.1007/s12325-019-00958-x. Epub 2019 May 3.
PMID: 31054035DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
January 27, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
May 4, 2016
Record last verified: 2016-04