Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months |
Paper fall calendars |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Primary |
Change from Baseline in Balance Confidence |
Activities-specific Balance Confidence questionnaire |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Primary |
Change from Baseline in Satisfaction with Participation in Social Roles |
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Satisfaction with Participation in Social Roles |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Primary |
Change from Baseline in Ability to Participate in Social Roles and Activities |
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 2.0 - Ability to Participate in Social Roles and Activities |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Primary |
Change from Baseline in Quality of Life |
Multiple Sclerosis Impact Scale-29 |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Primary |
Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars |
The Mobile RF Fall Detection System automatically records falls per day experienced by the wearer. The results obtained by the fall detector will be tested for accuracy against the self-reported falls reported on paper fall calendars, in which participants manually record falls per day on a paper log. |
8 weeks |
|
Secondary |
Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months |
Timed Up and Go |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Secondary |
Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months |
Four Square Step Test |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Secondary |
Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months |
International Physical Activity Questionnaire, short form |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months from baseline), 6 months after program completion (9 weeks + 6 months + baseline) |
|
Secondary |
Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months |
Fall Prevention Strategy Survey |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Secondary |
Change from Baseline in Fatigue at Completion of Program and the Following Six Months |
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Secondary |
Change from Baseline in Mobility at Completion of Program and the Following Six Months |
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Secondary |
Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months |
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Psychosocial Illness Impact - Positive |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|
Secondary |
Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months |
Fall Prevention Knowledge and Confidence Questionnaire |
At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months) |
|