Clinical trial NCT02743312: Long-Term Effects of Torso-Weighting
Official title: Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Balance-Based Torso-Weighting
Physical Activity
Neurorehabilitation
Lead sponsor: San Francisco State University
Sponsor class: OTHER
Collaborators: name: Samuel Merritt University
First posted: 2016-04-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Steps Per Day
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Sensory Organization Test
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Gait Velocity
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Activities-Specific Balance Confidence Scale
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Multiple Sclerosis Impact Scale 29
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Multiple Sclerosis Walking Scale 12
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Six-Minute Walk Test
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Stride Length
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Percent of Gait Cycle in Single Limb Support
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Step Width
timeFrame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
measure: Electromyography to Assess Muscle Activation
timeFrame: Week 4, Week 6, Week 8
measure: Number of Falls Recorded in 2 Weeks of Wear Time.
timeFrame: count of number of falls recorded at the end of two weeks of wearing TW or SW
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Samuel Merritt University, Motion Analysis Research Center
state: California
Study officials:
affiliation: San Francisco State University
name: Diane Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: