Long-Term Effects of Torso-Weighting

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02743312
• Date of registration: 07/10/2015
• Prospective Registration: Yes
• Primary sponsor: San Francisco State University
• Public title: Long-Term Effects of Torso-Weighting TWPS
• Scientific title: Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
• Date of first enrolment: November 2015
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02743312
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Diane Allen, PhD
• Affiliation: San Francisco State University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Device: Fitbit Flex

Device: Sham Weights

Device: Torso Weights

Primary Outcome(s)

Steps Per Day [Time Frame: up to 8 weeks]

Secondary Outcome(s)

Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT) [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Percent of Gait Cycle in Single Limb Support [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Number of Falls Recorded in 2 Weeks of Wear Time. [Time Frame: count of number of falls recorded at the end of two weeks of wearing TW or SW]

Electromyography to Assess Muscle Activation [Time Frame: Week 4, Week 6, Week 8]

Multiple Sclerosis Impact Scale 29 [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Sensory Organization Test [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Activities-Specific Balance Confidence Scale [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Six-Minute Walk Test [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Multiple Sclerosis Walking Scale 12 [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Step Width [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Gait Velocity [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Stride Length [Time Frame: change from initiation to 2-weeks after initiation of daily wearing of TW or SW]

Secondary ID(s)

X15-48a

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Samuel Merritt University

Results

• Results available: Yes
• Date Posted: 06/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02743312