NCT02743312|CompletedResults
Long-Term Effects of Torso-Weighting
TWPS
Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
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TWPS
Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
Sponsor study identifier
interventional
5
1 country
1
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2015
Actual (reported)November 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 19, 2016
Actual (reported)May 2016
Actual (reported)June 2016
Actual (reported)November 6, 2018
Actual (reported)Steps Per Day
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
up to 8 weeks
Sensory Organization Test
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Gait Velocity
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Movement 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
Multiple Sclerosis Impact Scale 29
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
No weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with sham weights for 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout.
No weights worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights for 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout.
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Samuel Merritt University, Motion Analysis Research Center
Oakland, California, 94609, United States
Diane Allen, PhD
San Francisco State University
5 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2015
First Posted
April 19, 2016
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
November 6, 2018
Results First Posted
November 6, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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