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Completed

NCT Number: NCT02743312

Long-Term Effects of Torso-Weighting

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samuel Merritt University, Motion Analysis Research Center

Oakland, California, 94609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Torso Weights

Device

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

Other names: WT

Sham Weights

Device

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

Fitbit Flex

Device

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

Primary outcomes

  1. Steps Per Day

    Time frame: up to 8 weeks

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

Secondary outcomes

  1. Sensory Organization Test

    Time frame: 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

  2. Gait Velocity

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

    As measured using instrumented gait mat.

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

    Time frame: 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.

  4. Activities-Specific Balance Confidence Scale

    Time frame: 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.

  5. Multiple Sclerosis Impact Scale 29

    Time frame: 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.

  6. Multiple Sclerosis Walking Scale 12

    Time frame: 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.

  7. Six-Minute Walk Test

    Time frame: 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.

  8. Stride Length

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

    As measured using instrumented gait mat.

  9. Percent of Gait Cycle in Single Limb Support

    Time frame: 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.

  10. Step Width

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

    As measured using instrumented gait mat.

  11. Electromyography to Assess Muscle Activation

    Time frame: 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.

  12. Number of Falls Recorded in 2 Weeks of Wear Time.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

San Francisco State University

Other

Collaborators

  • Samuel Merritt University

Registry information

Official study title

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

Acronym: TWPS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 19, 2016
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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