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NCT Number: NCT06981013

Effects of Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis

Rationale: The Balance-Based Torso-Weighting (BBTW) is a patented evaluation system that uses strategic placement of small or lightweight weights on the trunk to improve balance and stability. BBTW has been found to improve the upright mobility of people with multiple sclerosis, however the mechanism underlying the improvement of balance and gait is still unknown.1-2 Purpose: The purpose of this study is to investigate the immediate effects of BBTW on muscle activation of tibialis anterior and gastrocsoleus and sway using electromyography and force plates during balance tests in people with MS and healthy controls?

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Research Questions:

Question #1 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes open? Question #2 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes closed? Question #3 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes open? Question #4 - Is there a difference in EMG within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes closed? Question #5 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes open? Question #6 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when not wearing weighted vest with eyes closed? Question #7 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes open? Question #8 - Is there a difference in SWAY within postural muscles (tibialis anterior and gastrocsoleus) and between healthy and MS when wearing weighted vest eyes closed? Research Design: Quasi-experimental design

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Individuals with Multiple Sclerosis group:

  • self-reported diagnosis of multiple sclerosis (MS)
  • age 18 to 75 years old
  • able to communicate in English
  • able to provide informed consent
  • able to tolerate up to three hours of testing with rest breaks
  • able to walk 20 meters with or without assistive device and without resting (equivalent to Expanded Disability Status Scale of 6.5 or less).

Inclusion criteria

for the Healthy Control group:

  • able to communicate in English
  • able to provide informed consent
  • physical criteria that matched each participant with MS which included age (within 7 years), height (within 12.7 cm [5 in]), mass (within 9.1 kg [20 lb]) and sex.

Exclusion criteria

for Individuals with Multiple Sclerosis group:

  • exacerbation of MS within the past two months
  • had a diagnosis of a concurrent neurological disorder (head injury, stroke, Parkinson's disease, etc.)
  • reported pain that could be exacerbated by external perturbations during standing.

Exclusion criteria

for Healthy control group:

  • Known diagnoses
  • current pain that could affect balance.

Treatment and study plan

balance based torso weighting

Other

The intervention in this study is the Balance-Based-Torso-Weighting (BBTW) which will be applied on individuals with MS and healthy controls. It involves the strategic placement of weights based on the assessment of the loss of balance in three dimensions: anterior-posterior, lateral, rotational to counteract the balance loss.4 The BBTW Evaluation Tool Kit will be used to determine the location of the weights. It consists of an adjustable testing vest; rigid orthotic; five pounds worth of weights divided into 1/16, 1/8, 1/4, 1/2 lb. increments; and exam evaluation forms (www.motiontherapeutics.com).

Primary outcomes

  1. Muscle Activation of B lateral gastrocnemius and tibialis anterior

    Time frame: Baseline and study completion, after an average of three hours

    Noraxon EMG will be used to measure muscle activation

  2. Postural Sway as measured by center of pressure displacement

    Time frame: Baseline and study completion, after an average of three hours

    Kistler Force Plate will be used center of pressure displacement in the x and y axis

Study contacts

Contact information is provided by the study sponsor or research team.

Amie F Jasper, DPT, PhD

CONTACT

[email protected]

904-770-3482

Evan Pucillo

CONTACT

[email protected]

9047703549

Sponsors and collaborators

Lead sponsor

University of St. Augustine for Health Sciences

Other

Registry information

Official study title

Effects of Balance-based Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis

Acronym: BBTW-MS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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