Long-Term Effects of Torso-Weighting (TWPS)

San Francisco State University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Fitbit Flex; Device: Torso Weights; Device: Sham Weights

Study type: Interventional

Funder types: Other

Identifiers

NCT02743312

X15-48a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups

Torso Weights then Sham Weights

Experimental group

Description:

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.

Treatment:

Device: Sham Weights

Device: Torso Weights

Device: Fitbit Flex

Sham Weights then Torso Weights

Experimental group

Description:

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.

Treatment:

Device: Sham Weights

Device: Torso Weights

Device: Fitbit Flex