Long-Term Effects of Torso-Weighting

NCT02743312 | Completed Results

• 1 other identifier: X15-48a
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Balance-Based Torso-Weighting; Physical Activity; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Steps Per Day

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

  up to 8 weeks

Secondary Outcomes (12)

• Sensory Organization Test

  change from initiation to 2-weeks after initiation of daily wearing of TW or SW

• Gait Velocity

  change from initiation to 2-weeks after initiation of daily wearing of TW or SW

• Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)

  change from initiation to 2-weeks after initiation of daily wearing of TW or SW

• Activities-Specific Balance Confidence Scale

  change from initiation to 2-weeks after initiation of daily wearing of TW or SW

• Multiple Sclerosis Impact Scale 29

  change from initiation to 2-weeks after initiation of daily wearing of TW or SW

Study Arms (2)

Torso Weights then Sham Weights

EXPERIMENTAL

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.

Device: Torso Weights; Device: Sham Weights; Device: Fitbit Flex

Sham Weights then Torso Weights

EXPERIMENTAL

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.

Device: Torso Weights; Device: Sham Weights; Device: Fitbit Flex

Interventions

Torso Weights DEVICE

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

Also known as: WT

Sham Weights then Torso Weights; Torso Weights then Sham Weights

Sham Weights 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.

Also known as: SW

Sham Weights then Torso Weights; Torso Weights then Sham Weights

Fitbit Flex DEVICE

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

Also known as: remote activity monitoring device

Sham Weights then Torso Weights; Torso Weights then Sham Weights

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Francisco State University: lead
• Samuel Merritt University: collaborator

Study Sites (1)

Samuel Merritt University, Motion Analysis Research Center

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Results Point of Contact

• Title: Dr. Diane Allen
• Organization: San Francisco State University

ddallen@sfsu.edu

4153386837

Study Officials

• Diane Allen, PhD

  San Francisco State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: April 19, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 6, 2018
• Results First Posted: November 6, 2018

Record last verified: 2018-10

Locations

US (1)