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Recruiting NCT06981013

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

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: balance based torso weighting.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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 weight

Primary outcome measures

  • Muscle Activation of B lateral gastrocnemius and tibialis anterior [Time frame: Baseline and study completion, after an average of three hours]
  • Postural Sway as measured by center of pressure displacement [Time frame: Baseline and study completion, after an average of three hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of St. Augustine for Health Sciences — Saint Augustine

Identifiers

NCT: NCT06981013 · 23-1101-275

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗