Long-Term Effects of Torso-Weighting (TWPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Torso Weights; Device: Sham Weights; Device: Fitbit Flex

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • Samuel Merritt University, Motion Analysis Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Torso Weights then 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.	Device: Torso Weights; Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.; Other Names: WT; 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.; Other Names: SW; Device: Fitbit Flex; Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.; Other Names: remote activity monitoring device
Experimental: Sham Weights then 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.	Device: Torso Weights; Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.; Other Names: WT; 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.; Other Names: SW; Device: Fitbit Flex; Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.; Other Names: remote activity monitoring device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Gait Velocity	As measured using instrumented gait mat.	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.	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.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Impact Scale 29	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.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Multiple Sclerosis Walking Scale 12	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.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Six-Minute Walk Test	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.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Stride Length	As measured using instrumented gait mat.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Percent of Gait Cycle in Single Limb Support	As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Step Width	As measured using instrumented gait mat.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Electromyography to Assess Muscle Activation	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.	Week 4, Week 6, Week 8
Number of Falls Recorded in 2 Weeks of Wear Time.	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.	count of number of falls recorded at the end of two weeks of wearing TW or SW

Collaborators and Investigators

• Sponsor: San Francisco State University
• Collaborators: Samuel Merritt University
• Investigators: Principal Investigator: Diane Allen, PhD, San Francisco State University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Physical Activity; Neurorehabilitation; Balance-Based Torso-Weighting
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Body Weight
• Other Study ID Numbers: X15-48a