Trial Outcomes & Findings for Long-Term Effects of Torso-Weighting (NCT NCT02743312)
NCT ID: NCT02743312
Last Updated: 2018-11-06
Results Overview
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
up to 8 weeks
Results posted on
2018-11-06
Participant Flow
5 volunteers were screened for eligibility from November 1, 2015, to April 1, 2016.
All 5 volunteers were enrolled.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Torso Weights Then Sham Weights
n=3 Participants
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.
|
Sham Weights Then Torso Weights
n=2 Participants
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.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksPopulation: Server where data were stored failed. No data analyzed for any participant.
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWbalance 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
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Sensory Organization Test
|
7.4 scores on a scale
Standard Deviation 8.4
|
1 scores on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWAs measured using instrumented gait mat.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Gait Velocity
|
.125 meters/second
Standard Deviation .14
|
-.03 meters/second
Standard Deviation .14
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWOnline 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.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
|
.36 units on a scale
Standard Deviation 1.8
|
.3 units on a scale
Standard Deviation .7
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWSelf-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.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Activities-Specific Balance Confidence Scale
|
1.5 units on a scale
Standard Deviation 6.6
|
3 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWSelf-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.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Multiple Sclerosis Impact Scale 29
Physical score
|
-6.7 units on a scale
Standard Deviation 4.7
|
-5.25 units on a scale
Standard Deviation 10.5
|
|
Multiple Sclerosis Impact Scale 29
Psychological score
|
-4.4 units on a scale
Standard Deviation 12.2
|
-6.1 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWSelf-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.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Multiple Sclerosis Walking Scale 12
|
-7.9 units on a scale
Standard Deviation 9.6
|
-0.8 units on a scale
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWdistance 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.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Six-Minute Walk Test
|
47.4 meters walked
Standard Deviation 52
|
-19 meters walked
Standard Deviation 44.3
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWAs measured using instrumented gait mat.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Stride Length
|
.09 meters
Standard Deviation .09
|
-.02 meters
Standard Deviation .11
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWAs measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Percent of Gait Cycle in Single Limb Support
|
.0067 percentage of gait cycle on one limb
Standard Deviation .0062
|
-.0026 percentage of gait cycle on one limb
Standard Deviation .0072
|
SECONDARY outcome
Timeframe: change from initiation to 2-weeks after initiation of daily wearing of TW or SWAs measured using instrumented gait mat.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Step Width
|
-.0084 meters
Standard Deviation .03
|
.014 meters
Standard Deviation .014
|
SECONDARY outcome
Timeframe: Week 4, Week 6, Week 8Population: timing and marker difficulties along with equipment malfunction at some visits resulted in data that could not be analyzed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: count of number of falls recorded at the end of two weeks of wearing TW or SWPopulation: total falls in each arm
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.
Outcome measures
| Measure |
Torso Weights
n=5 Participants
Garment with torso weights worn 2-4 hours daily for 2 weeks.
Torso Weights: Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
|
Sham Weights
n=5 Participants
Garment with sham weights worn 2-4 hours daily for 2 weeks.
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.
|
|---|---|---|
|
Number of Falls Recorded in 2 Weeks of Wear Time.
|
0 falls
|
1 falls
|
Adverse Events
Torso Weights
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Weights
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-weighting (no Weights)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place