Multiple SclerosisBBTW-MSNCT06981013
Effects of Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis
A study testing balance based torso weighting in people with Multiple Sclerosis, run by University of St. Augustine for Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- balance based torso weighting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known diagnoses
- current pain that could affect balance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of St. Augustine for Health Sciences
Saint Augustine, Florida, 32086
Amie Marie F Jasper, DPT, PhD, 904-770-3482, amjasper@usa.edu
Evan Pucillo, 9047703549, epucillo@usa.edu
About this study
Official title: Effects of Balance-based 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?
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- balance based torso weighting
- Keywords
- Multiple Sclerosis, muscle activation, ankle muscles, balance vest
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance based torso weightingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis Arm | Experimental | Without and with balance-based torso weighting Receives: Other: balance based torso weighting |
| Healthy Control Arm | Active comparator | Without and with balance-based torso weighting Receives: Other: balance based torso weighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Activation of B lateral gastrocnemius and tibialis anterior
Noraxon EMG will be used to measure muscle activation
Measured: 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
Measured: Baseline and study completion, after an average of three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 20 participants with multiple sclerosis and 20 participants without multiple sclerosis in a Quasi experimental design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of St. Augustine for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan M. Pucillo, PT, DPT, EdD, University of St. Augustine for Health Sciences
- Investigators
- Amie Marie F Jasper, DPT, PhD, Principal investigator, USAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981013
- Sponsor's protocol ID
- 23-1101-275
- Acronym
- BBTW-MS
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance-based Torso Weighting on Muscle Activation During Balance Tests in Individuals With and Without Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06981013
- Acronym / sponsor ID
- BBTW-MS / 23-1101-275
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, muscle activation, ankle muscles, balance vest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of St. Augustine for Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 participants with multiple sclerosis and 20 participants without multiple sclerosis in a Quasi experimental design
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis Arm | Experimental | Other: balance based torso weightingWithout and with balance-based torso weighting |
| Healthy Control Arm | Active comparator | Other: balance based torso weightingWithout and with balance-based torso weighting |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- exacerbation of MS within the past two months
- had a diagnosis of a concurrent neurological disorder (head injury, stroke, Parkinson's disease, etc.)
Key exclusion criteria (2 listed)
- Known diagnoses
- current pain that could affect balance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balance based torso weightingThe 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). | Other | Healthy Control Arm, Multiple Sclerosis Arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amie Marie F Jasper, DPT, PhD principal investigator
USAHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance based torso weighting in people with Multiple Sclerosis, run by University of St. Augustine for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amie F Jasper, DPT, PhD (904-770-3482, amjasper@usa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Activation of B lateral gastrocnemius and tibialis anterior (time frame: Baseline and study completion, after an average of three hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.