NCT06981013 · University of St. Augustine for Health Sciences
Effects of Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis
(BBTW-MS)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
balance based torso weighting
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 outcome measures
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Saint Augustine, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2025 · Source of record for eligibility and locations