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Long-Term Effects of Torso-Weighting (TWPS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Torso Weights
Sham Weights
Fitbit Flex
Sponsored by
San Francisco State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Balance-Based Torso-Weighting, Physical Activity, Neurorehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samuel Merritt University, Motion Analysis Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Torso Weights then Sham Weights

Sham Weights then Torso Weights

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Gait Velocity
As measured using instrumented gait mat.
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.
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.
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.
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.
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.
Stride Length
As measured using instrumented gait mat.
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.
Step Width
As measured using instrumented gait mat.
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.
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.

Full Information

First Posted
October 7, 2015
Last Updated
October 9, 2018
Sponsor
San Francisco State University
Collaborators
Samuel Merritt University
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1. Study Identification

Unique Protocol Identification Number
NCT02743312
Brief Title
Long-Term Effects of Torso-Weighting
Acronym
TWPS
Official Title
Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
San Francisco State University
Collaborators
Samuel Merritt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Balance-Based Torso-Weighting, Physical Activity, Neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Torso Weights then Sham Weights
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Weights then Torso Weights
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Torso Weights
Other Intervention Name(s)
WT
Intervention Description
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Intervention Type
Device
Intervention Name(s)
Sham Weights
Other Intervention Name(s)
SW
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fitbit Flex
Other Intervention Name(s)
remote activity monitoring device
Intervention Description
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Primary Outcome Measure Information:
Title
Steps Per Day
Description
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Sensory Organization Test
Description
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
Title
Gait Velocity
Description
As measured using instrumented gait mat.
Time Frame
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Title
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
Description
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
Title
Activities-Specific Balance Confidence Scale
Description
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
Title
Multiple Sclerosis Impact Scale 29
Description
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
Title
Multiple Sclerosis Walking Scale 12
Description
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
Title
Six-Minute Walk Test
Description
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
Title
Stride Length
Description
As measured using instrumented gait mat.
Time Frame
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Title
Percent of Gait Cycle in Single Limb Support
Description
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
Title
Step Width
Description
As measured using instrumented gait mat.
Time Frame
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Title
Electromyography to Assess Muscle Activation
Description
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
Title
Number of Falls Recorded in 2 Weeks of Wear Time.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Allen, PhD
Organizational Affiliation
San Francisco State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel Merritt University, Motion Analysis Research Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States

12. IPD Sharing Statement

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Long-Term Effects of Torso-Weighting

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