N/A
N=5
Long-Term Effects of Torso-Weighting
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02743312 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Steps Per Day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Torso Weights (Device); Sham Weights (Device); Fitbit Flex (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- San Francisco State University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steps Per Day |
— | — |
| SECONDARY Sensory Organization Test |
7.4; 1 | — |
| SECONDARY Gait Velocity |
.125; -.03 | — |
| SECONDARY Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT) |
.36; .3 | — |
| SECONDARY Activities-Specific Balance Confidence Scale |
1.5; 3 | — |
| SECONDARY Multiple Sclerosis Impact Scale 29 |
-6.7; -5.25; -4.4; -6.1 | — |
| SECONDARY Multiple Sclerosis Walking Scale 12 |
-7.9; -0.8 | — |
| SECONDARY Six-Minute Walk Test |
47.4; -19 | — |
| SECONDARY Stride Length |
.09; -.02 | — |
| SECONDARY Percent of Gait Cycle in Single Limb Support |
.0067; -.0026 | — |
| SECONDARY Step Width |
-.0084; .014 | — |
| SECONDARY Electromyography to Assess Muscle Activation |
— | — |
| SECONDARY Number of Falls Recorded in 2 Weeks of Wear Time. |
0; 1 | — |
Summary
The goal of this pilot study is to test the protocol for investigating the longer-term effects of torso weighting on physical activity, number of falls, and muscle activation (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis. The hypotheses of this study include: torso weighting will (1) increase physical activity, (2) decrease the number of falls, and (3) improve the timing and coordination of muscle activation during balance perturbations.
Eligibility Criteria
Inclusion Criteria
- Self-reported a diagnosis of multiple sclerosis
- Self-reported mild or moderate gait or balance difficulties
- Living in the community rather than in a care facility
- Able to walk independently for at least one minute at a time with or without an assistive device
- No exacerbations within the past 2 months
- Able to get to the testing area and tolerate 2-3 hours of testing for each assessment occasion
- Willing to be nudged by a researcher when standing
Exclusion Criteria
- Unable to comprehend and follow instructions in English
- Current diagnosis of other neurological disorders such as head injury, stroke, Parkinson disease, or other conditions that affect gait or balance (self-reported)
- Experiencing pain that could be exacerbated by external perturbation while standing
- History of skin reaction to adhesives
Data sourced from ClinicalTrials.gov (NCT02743312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.