NCT02743312

Long-Term Effects of Torso-Weighting

Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: San Francisco State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Torso weighting, using the balance-based torso-weighting (BBTW) method, is an intervention that addresses balance by first challenging stability in standing using a series of perturbations (nudges) and resisted rotations to people. Challenging stability allows the assessor to determine directional instability. Once the direction of instability is determined, small weights are placed on a vest-like garment and retesting of balance occurs. In this study, participants will be tested with no weights (NW), with sham weights (SW), and with BBTW weighting (WT). Following non-weighted baseline assessment, participants will be randomly allocated into the sham weight condition or BBTW weight condition in a cross-over design. The initial condition (NW) will last four weeks and the final two conditions (SW,WT) will last two weeks each. Following each condition, outcome measures will be reassessed. Throughout the study, participants will be asked to wear a commercially-available remote monitoring device (e.g., Fitbit Flex) and keep a daily log of physical activity and number of falls. During the SW and WT conditions, participants will wear the assigned garment for 2-4 hours daily.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Torso Weights	Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
DEVICE	Sham Weights	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.
DEVICE	Fitbit Flex	Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2016-04-19
• Last updated: 2018-11-06
• Results posted: 2018-11-06

Locations

1 site across 1 country: United States