Multiple Sclerosis
Conditions
Keywords
Balance-Based Torso-Weighting, Physical Activity, Neurorehabilitation
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.
Interventions
DEVICETorso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
DEVICESham 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.
DEVICEFitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Sponsors
Samuel Merritt University
San Francisco State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps Per Day | up to 8 weeks | Continuous activity data collection via commercially-available remote monitoring device and stored on server. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity | change from initiation to 2-weeks after initiation of daily wearing of TW or SW | As measured using instrumented gait mat. |
| 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. |
| 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 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. |
| 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. |
| 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 |
| Stride Length | change from initiation to 2-weeks after initiation of daily wearing of TW or SW | As measured using instrumented gait mat. |
| 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. |
| Step Width | change from initiation to 2-weeks after initiation of daily wearing of TW or SW | As measured using instrumented gait mat. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
5 volunteers were screened for eligibility from November 1, 2015, to April 1, 2016.
Pre-assignment details
All 5 volunteers were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Sham Weights Then Torso Weights | Total | Torso Weights Then Sham Weights |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Steps Per Day
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
Time frame: up to 8 weeks
Population: Server where data were stored failed. No data analyzed for any participant.
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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Activities-Specific Balance Confidence Scale | 1.5 units on a scale | Standard Deviation 6.6 |
| Sham Weights | Activities-Specific Balance Confidence Scale | 3 units on a scale | Standard Deviation 6.9 |
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.
Time frame: Week 4, Week 6, Week 8
Population: timing and marker difficulties along with equipment malfunction at some visits resulted in data that could not be analyzed.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Gait Velocity | .125 meters/second | Standard Deviation 0.14 |
| Sham Weights | Gait Velocity | -.03 meters/second | Standard Deviation 0.14 |
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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT) | .36 units on a scale | Standard Deviation 1.8 |
| Sham Weights | Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT) | .3 units on a scale | Standard Deviation 0.7 |
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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Torso Weights | Multiple Sclerosis Impact Scale 29 | Psychological score | -4.4 units on a scale | Standard Deviation 12.2 |
| Torso Weights | Multiple Sclerosis Impact Scale 29 | Physical score | -6.7 units on a scale | Standard Deviation 4.7 |
| Sham Weights | Multiple Sclerosis Impact Scale 29 | Physical score | -5.25 units on a scale | Standard Deviation 10.5 |
| Sham Weights | Multiple Sclerosis Impact Scale 29 | Psychological score | -6.1 units on a scale | Standard Deviation 10.3 |
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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Multiple Sclerosis Walking Scale 12 | -7.9 units on a scale | Standard Deviation 9.6 |
| Sham Weights | Multiple Sclerosis Walking Scale 12 | -0.8 units on a scale | Standard Deviation 13.3 |
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.
Time frame: count of number of falls recorded at the end of two weeks of wearing TW or SW
Population: total falls in each arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Torso Weights | Number of Falls Recorded in 2 Weeks of Wear Time. | 0 falls |
| Sham Weights | Number of Falls Recorded in 2 Weeks of Wear Time. | 1 falls |
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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Percent of Gait Cycle in Single Limb Support | .0067 percentage of gait cycle on one limb | Standard Deviation 0.0062 |
| Sham Weights | Percent of Gait Cycle in Single Limb Support | -.0026 percentage of gait cycle on one limb | Standard Deviation 0.0072 |
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
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Sensory Organization Test | 7.4 scores on a scale | Standard Deviation 8.4 |
| Sham Weights | Sensory Organization Test | 1 scores on a scale | Standard Deviation 9.7 |
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.
Time frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Six-Minute Walk Test | 47.4 meters walked | Standard Deviation 52 |
| Sham Weights | Six-Minute Walk Test | -19 meters walked | Standard Deviation 44.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Step Width | -.0084 meters | Standard Deviation 0.03 |
| Sham Weights | Step Width | .014 meters | Standard Deviation 0.014 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Torso Weights | Stride Length | .09 meters | Standard Deviation 0.09 |
| Sham Weights | Stride Length | -.02 meters | Standard Deviation 0.11 |