Long-Term Effects of Torso-Weighting

Not Applicable

Completed

Conditions: Multiple Sclerosis

Interventions: Device: Torso Weights
Device: Sham Weights
Device: Fitbit Flex

Registration Number: NCT02743312

Lead Sponsor: San Francisco State University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Weights then Torso Weights	Torso Weights	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.
Torso Weights then Sham Weights	Torso Weights	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.
Torso Weights then Sham Weights	Fitbit Flex	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.
Sham Weights then Torso Weights	Sham Weights	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.
Torso Weights then Sham Weights	Sham Weights	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.
Sham Weights then Torso Weights	Fitbit Flex	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.

Primary Outcome Measures

Name	Time	Method
Steps Per Day	up to 8 weeks	Continuous activity data collection via commercially-available remote monitoring device and stored on server.

Secondary Outcome Measures

Name	Time	Method
Sensory Organization Test	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	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
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	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.
Stride Length	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	As measured using instrumented gait mat.
Number of Falls Recorded in 2 Weeks of Wear Time.	count of number of falls recorded at the end of two weeks of wearing TW or SW	Daily log manually recorded by participant for the 2 weeks of wear time. This is a descriptive measure recording the total count (number) of falls per arm.
Activities-Specific Balance Confidence Scale	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	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.
Multiple Sclerosis Walking Scale 12	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	Self-report measure of the effect of MS on walking ability. Larger numbers out of 100 mean that MS limits walking much more. Data are reported as change in score from initiation of TW or SW to the visit after 2 weeks of daily wear of TW or SW.
Electromyography to Assess Muscle Activation	Week 4, Week 6, Week 8	Recording of muscle activation during quiet and perturbed standing before and after intervention at weeks 4, 6, and 8. Average values with and without weighting during each visit.
Step Width	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	As measured using instrumented gait mat.
Six-Minute Walk Test	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	distance participant walks in 6 minutes. Larger numbers indicate more distance covered. Data reported are the change in distance walked from initiation of TW or SW to after 2 weeks of daily wear.
Gait Velocity	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	As measured using instrumented gait mat.
Multiple Sclerosis Impact Scale 29	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	Self-report measure of the impact of MS on activities and participation. The scale is reported in a physical and psychological subscale, with higher numbers (out of 100) indicating worse impact of multiple sclerosis (MS) on function. Data are reported as change from initiation of TW or SW to end of 2 weeks of daily wear.
Percent of Gait Cycle in Single Limb Support	change from initiation to 2-weeks after initiation of daily wearing of TW or SW	As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.