Long-Term Effects of Torso-Weighting
Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Torso Weights
- Fitbit Flex
Placebo
- Sham Weights
Results by group
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Torso Weights | 5 | 0 (0.0%) | 0 |
| Sham Weights | 5 | 0 (0.0%) | 0 |
| Pre-weighting (no Weights) | 5 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Steps Per Day
up to 8 weeks
Physical function
Other measures (12)
Sensory Organization Test
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobilityGait Velocity
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobilityMovement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Activities-Specific Balance Confidence Scale
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobilityMultiple Sclerosis Impact Scale 29
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Walking Scale 12
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobilitySix-Minute Walk Test
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobilityStride Length
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobilityPercent of Gait Cycle in Single Limb Support
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobilityStep Width
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Walking and mobility
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Nov 2015
Main results due
May 2016
Finished
Jun 2016
Results posted
Nov 2018