Long-Term Effects of Torso-Weighting

NCT ID: NCT02743312

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-06-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Torso Weights

Intervention Type: DEVICE

Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.

Sham Weights

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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 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.

Group Type: EXPERIMENTAL

Torso Weights

Intervention Type: DEVICE

Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.

Sham Weights

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.

Interventions

Torso Weights

Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Fitbit Flex

Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.

Intervention Type: DEVICE

Other Intervention Names

WT; SW; remote activity monitoring device

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samuel Merritt University

OTHER

Sponsor Role: collaborator

San Francisco State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diane Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

San Francisco State University

Locations

Samuel Merritt University, Motion Analysis Research Center

Oakland, California, United States

Countries

United States

Other Identifiers

X15-48a

Identifier Type: -

Identifier Source: org_study_id