Long-Term Effects of Torso-Weighting

Multiple Sclerosis Clinical Trial

— TWPS  

Official title:

Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743312
• Other study ID #: X15-48a
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2018
• Source: San Francisco State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Multiple Sclerosis

Intervention

Device:
• 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
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.

Locations

Country	Name	City	State
United States	Samuel Merritt University, Motion Analysis Research Center	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
San Francisco State University	Samuel Merritt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steps Per Day	Continuous activity data collection via commercially-available remote monitoring device and stored on server.	up to 8 weeks
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	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Secondary	Gait Velocity	As measured using instrumented gait mat.	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.	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.	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.	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.	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.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Secondary	Stride Length	As measured using instrumented gait mat.	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.	change from initiation to 2-weeks after initiation of daily wearing of TW or SW
Secondary	Step Width	As measured using instrumented gait mat.	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.	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.	count of number of falls recorded at the end of two weeks of wearing TW or SW