MSPT Device Usability Study

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT02664324
• Lead Sponsor: Biogen

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Study Start: 2016-03
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Key

Exclusion Criteria

• 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.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of study participants successfully completing all modules of the MSPT device	Through study duration (3-4 hours)	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
Percent (%) of study participants successfully completing all modules of the MSPT device	Through study duration (3-4 hours)

Secondary Outcome Measures

Name	Time	Method
Percent (%) of study participants who reported being satisfied or completely satisfied with using MSPT device	Through study duration (3-4 hours)	MSPT satisfaction survey is a 1 item paper-based questionnaire to measure participant satisfaction with the MSPT device.
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)
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 satisfied/completely satisfied on MSPT Satisfaction Survey	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)	T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet.
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)	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Cleveland, Ohio, United States