Long-Term Effects of Torso-Weighting

San Francisco State University5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Torso WeightsDEVICE

Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.

Sham WeightsDEVICE

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.

Fitbit FlexDEVICE

Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Samuel Merritt University, Motion Analysis Research Center

Oakland, California, United States

Outcomes

Primary Outcomes

Steps Per Day

Continuous activity data collection via commercially-available remote monitoring device and stored on server.

Time frame: up to 8 weeks

Secondary Outcomes

Sensory Organization Test

balance tested during 6 conditions on Neuro-com forceplate and surround and reported as a composite score (across the six conditions), 0-100, with higher scores indicating better balance; measure reported reflects change in the composite score from the visit that initiates Torso-weighting (TW) or sham weights (SW) to the visit that concludes daily wearing of TW or SW

Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW

Gait Velocity

As measured using instrumented gait mat.

Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW

Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)

Online self-report of perceived current movement ability and preferred movement ability. The scores are reported in standardized logits, 0-6, where 6 is competitive level athletic movement. The reported values are the average change in current movement ability from initiation of daily wear to after 2 weeks of daily wear of TW or SW.

Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW

Activities-Specific Balance Confidence Scale

Self-report measure of perception of confidence under various balance challenges on a scale of 0-100 with 100 being fully confident that the individual can perform the listed balance challenge without falling. Data reported reflect the difference in scores from initiation to the 2-week point after initiation of TW or SW.

Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW

Data from ClinicalTrials.gov

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