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| Name | Class |
|---|---|
| Samuel Merritt University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Torso Weights then Sham Weights | Experimental | 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. |
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| Sham Weights then Torso Weights | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Torso Weights | Device | Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Allen, PhD | San Francisco State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samuel Merritt University, Motion Analysis Research Center | Oakland | California | 94609 | United States |
All 5 volunteers were enrolled.
5 volunteers were screened for eligibility from November 1, 2015, to April 1, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout. Balance-Based Torso-Weighting (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 actual weights (but assessors and patients are not told which weights are placed). Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device. |
| FG001 | Sham Weights Then Torso Weights | No weights are 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 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout. Sham Weights (SW): 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 (assessors and patients are not told which weights are placed). Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Torso 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 actual weights (but the assessors and patients do not know which weights are placed). 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. Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Steps Per Day | Continuous activity data collection via commercially-available remote monitoring device and stored on server. | Server where data were stored failed. No data analyzed for any participant. | Posted | up to 8 weeks |
|
6 months, beginning to end of data collection of any participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Torso Weights | Garment with torso weights worn 2-4 hours daily for 2 weeks. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diane Allen | San Francisco State University | 4153386837 | ddallen@sfsu.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| 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. |
|
|
| Fitbit Flex | Device | Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device. |
|
|
| 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 |
| BG001 | 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. 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 (but the assessors and patient do not know which weights are placed). Torso 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 actual weights. Fitbit Flex: Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | scores on a scale | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | Gait Velocity | As measured using instrumented gait mat. | Posted | Mean | Standard Deviation | meters/second | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | meters walked | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | Stride Length | As measured using instrumented gait mat. | Posted | Mean | Standard Deviation | meters | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of gait cycle on one limb | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | Step Width | As measured using instrumented gait mat. | Posted | Mean | Standard Deviation | meters | change from initiation to 2-weeks after initiation of daily wearing of TW or SW |
|
|
|
| Secondary | 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. | timing and marker difficulties along with equipment malfunction at some visits resulted in data that could not be analyzed. | Posted | Week 4, Week 6, Week 8 |
|
|
| Secondary | 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. | total falls in each arm | Posted | Number | falls | count of number of falls recorded at the end of two weeks of wearing TW or SW |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Sham Weights | Garment with sham weights worn 2-4 hours daily for 2 weeks. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Pre-weighting (no Weights) | 4 week baseline period in which participants wore activity monitor but had no other intervention. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |