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

NCT06981013 | Recruiting

• 1 other identifier: 23-1101-275
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; muscle activation; ankle muscles; balance vest

Outcome Measures

Primary Outcomes (2)

• Muscle Activation of B lateral gastrocnemius and tibialis anterior

  Noraxon EMG will be used to measure muscle activation

  Baseline and study completion, after an average of three hours

• Postural Sway as measured by center of pressure displacement

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

  Baseline and study completion, after an average of three hours

Study Arms (2)

Multiple Sclerosis Arm

EXPERIMENTAL

Without and with balance-based torso weighting

Other: balance based torso weighting

Healthy Control Arm

ACTIVE COMPARATOR

Without and with balance-based torso weighting

Other: balance based torso weighting

Interventions

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).

Healthy Control Arm; Multiple Sclerosis Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• Known diagnoses
• current pain that could affect balance.

Sponsors & Collaborators

• University of St. Augustine for Health Sciences: lead

Study Sites (1)

University of St. Augustine for Health Sciences

Saint Augustine, Florida, 32086, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Amie Marie F Jasper, DPT, PhD

  USAHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amie F Jasper, DPT, PhD

CONTACT

904-770-3482; amjasper@usa.edu

Evan Pucillo

CONTACT

9047703549; epucillo@usa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: 20 participants with multiple sclerosis and 20 participants without multiple sclerosis in a Quasi experimental design

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 20, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

US (1)