Clinical trial NCT06981013: Effects of Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis
Official title: Effects of Balance-based Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
muscle activation
ankle muscles
balance vest
Lead sponsor: University of St. Augustine for Health Sciences
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 participants with multiple sclerosis and 20 participants without multiple sclerosis in a Quasi experimental design
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle Activation of B lateral gastrocnemius and tibialis anterior
timeFrame: Baseline and study completion, after an average of three hours
measure: Postural Sway as measured by center of pressure displacement
timeFrame: Baseline and study completion, after an average of three hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Augustine
country: United States
facility: University of St. Augustine for Health Sciences
state: Florida
Study officials:
affiliation: USAHS
name: Amie Marie F Jasper, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: