An interventional study of Torso Weights and Sham Weights in Multiple Sclerosis, sponsored by San Francisco State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-06.
Sponsored by San Francisco State University · Not applicable, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →San Francisco State University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: Sham Weights · Device: 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.
Device: Torso Weights · Device: Sham Weights · Device: Fitbit Flex
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Also known as: WT
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.
Also known as: SW
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Also known as: remote activity monitoring device
Steps Per Day
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
Time frame: up to 8 weeks
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
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.
Time frame: 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.
Time frame: 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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Stride Length
As measured using instrumented gait mat.
Time frame: 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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Step Width
As measured using instrumented gait mat.
Time frame: 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.
Time frame: 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.
Time frame: count of number of falls recorded at the end of two weeks of wearing TW or SW
5 volunteers were screened for eligibility from November 1, 2015, to April 1, 2016.
| Milestone | Torso Weights Then Sham Weights | Sham Weights Then Torso Weights |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
No measurements were reported for this outcome.
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
| scores on a scale | Torso Weights | Sham Weights |
|---|---|---|
| Sensory Organization Test | 7.4 ± 8.4 | 1 ± 9.7 |
As measured using instrumented gait mat.
| meters/second | Torso Weights | Sham Weights |
|---|---|---|
| Gait Velocity | .125 ± .14 | -.03 ± .14 |
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.
| units on a scale | Torso Weights | Sham Weights |
|---|---|---|
| Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT) | .36 ± 1.8 | .3 ± .7 |
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.
| units on a scale | Torso Weights | Sham Weights |
|---|---|---|
| Activities-Specific Balance Confidence Scale | 1.5 ± 6.6 | 3 ± 6.9 |
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.
| units on a scale | Torso Weights | Sham Weights |
|---|---|---|
| Physical score | -6.7 ± 4.7 | -5.25 ± 10.5 |
| Psychological score | -4.4 ± 12.2 | -6.1 ± 10.3 |
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.
| units on a scale | Torso Weights | Sham Weights |
|---|---|---|
| Multiple Sclerosis Walking Scale 12 | -7.9 ± 9.6 | -0.8 ± 13.3 |
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.
| meters walked | Torso Weights | Sham Weights |
|---|---|---|
| Six-Minute Walk Test | 47.4 ± 52 | -19 ± 44.3 |
As measured using instrumented gait mat.
| meters | Torso Weights | Sham Weights |
|---|---|---|
| Stride Length | .09 ± .09 | -.02 ± .11 |
As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.
| percentage of gait cycle on one limb | Torso Weights | Sham Weights |
|---|---|---|
| Percent of Gait Cycle in Single Limb Support | .0067 ± .0062 | -.0026 ± .0072 |
As measured using instrumented gait mat.
| meters | Torso Weights | Sham Weights |
|---|---|---|
| Step Width | -.0084 ± .03 | .014 ± .014 |
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.
No measurements were reported for this outcome.
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.
| falls | Torso Weights | Sham Weights |
|---|---|---|
| Number of Falls Recorded in 2 Weeks of Wear Time. | 0 | 1 |
Collected over 6 months, beginning to end of data collection of any participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Torso Weights | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Sham Weights | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Pre-weighting (no Weights) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Torso Weights Then Sham Weights | Sham Weights Then Torso Weights | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Torso Weights Then Sham Weights | Sham Weights Then Torso Weights | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 1 | 0 | 1 |
| Race and Ethnicity Not Collected(Participants) | Torso Weights Then Sham Weights | Sham Weights Then Torso Weights | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Torso Weights Then Sham Weights | Sham Weights Then Torso Weights | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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San Francisco State University