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New treatment option for Multiple Sclerosis
Official title Functional Balance Intervention in Multiple Sclerosis
ClinicalTrials.gov ID: NCT06341023
What this study is testing
- What it's testing
- This project involves two sub-parts: Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms of Multiple Sclerosis. Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Telephone screening (for Study 1 and 2):
- Age group: Adults between 55-80 years of age
- Self-reported diagnosis of Multiple Sclerosis
- Be on stable disease modifying therapy (DMT) for ≥6 months.
- Has not received physical therapy or occupational therapy services for ≥6 months.
You likely can't join if
- Telephone Screening (for Study 1 and 2):
- MS Relapse or exacerbation ≤3 months
- Recent major surgery (\< 6 months) or hospitalization (\< 3 months) that might interfere with testing/training.
- Complaints of shortness of breath or uncontrolled pain (\>3/10 on visual analogue scale (VAS)) at rest to avoid complications/injuries during...
- Uncontrolled/untreated hypertension or diabetes to avoid cardiovascular complications during testing/training.
- Self-reported history of bone fracture in the last six months to avoid complications/injuries during testing/training.
See the full eligibility criteria
Who can join
- Telephone screening (for Study 1 and 2):
- Age group: Adults between 55-80 years of age
- Self-reported diagnosis of Multiple Sclerosis
- Be on stable disease modifying therapy (DMT) for ≥6 months.
- Has not received physical therapy or occupational therapy services for ≥6 months.
- Able to stand up from a chair independently with or without use of handrails.
- Score between 25-75% on the 12-item Multiple Sclerosis walking scale, which indicates that they have mobility disability or walking dysfunction.
- Absence of any other acute or chronic neurological (Stroke, Parkinson's disease), cardiopulmonary, musculoskeletal (injuries like fractures or dislocations or pathologies like Rheumatoid arthritis) or systemic...
- Can understand and communicate in English because the protocol will only be delivered in English.
- Be willing to complete all aspects of the study protocol (outcome assessments, 4-month training, accelerometer wear, etc.).
- Individuals who give a positive response (Yes) to the question of whether the participants feel that their memory or thinking skills worsened lately?" will be marked as potential individuals with mild cognitive...
- Must be willing to come to the lab for 2 times a week for four months for training sessions (for Study 1 participants only).
- Must have access to the internet and must be willing to attend weekly zoom calls and undergo monthly tests on zoom (for Study 2 participants only).
- Must be living with a family member (for Study 2 participants only).
- Must have a helper buddy to be present during the home exercise sessions and monthly progression evaluation Zoom calls with the researcher (for Study 2 participants only). In-person Screening (for Study 1 and 2):
- Must have mobility Disability, a score of 4.0-6.5 on the Expanded Disability Status Scale (EDSS).
- Must have mild cognitive impairment, a score of 18-25 on the Montreal Cognitive Assessment (MoCA) and score \>1 but less than 2.5 standard deviations on 2 or more measures within at least 1 domain (e.g., memory...
- Must be physically inactive, a score \<14 on the questionnaire named "Godin leisure time" questionnaire.
What rules you out
- Telephone Screening (for Study 1 and 2):
- MS Relapse or exacerbation ≤3 months
- Recent major surgery (\< 6 months) or hospitalization (\< 3 months) that might interfere with testing/training.
- Complaints of shortness of breath or uncontrolled pain (\>3/10 on visual analogue scale (VAS)) at rest to avoid complications/injuries during testing/training.
- Uncontrolled/untreated hypertension or diabetes to avoid cardiovascular complications during testing/training.
- Self-reported history of bone fracture in the last six months to avoid complications/injuries during testing/training.
- Self-reported disability in performing activities of daily living (with or without assistive device).
- Self-reported diagnosis of epilepsy or uncontrolled seizures in the past year.
- Intake of sedative drugs (diazepam, lorazepam, midazolam, propofol, dexmedetomidine, thiopental) that might interfere with testing/training.
- Intake of any Alzheimer's Disease (AD) or dementia modifying medications (donepezil, rivastigmine, galantamine, aducanumab) as well as other anticipated FDA approved drugs that may be approved during the next 5 years...
- Intake of anti-depressants or anxiety drugs.
- Moderate or high risk for possible injury or death when undertaking strenuous or maximal exercise as indicated by reporting a 'YES' on any of the seven items on the Physical Activity Readiness Questionnaire. These...
- People with severe cognitive impairment will be excluded, indicated by a score of 18 or higher on the Telephone Interview for Cognitive status (TICS-M). These participants will be advised to seek medical guidance from...
- Currently undergoing any cognitive rehabilitation for higher brain functions or physical rehabilitation.
- Pacemaker users In-person Screening (for Study 1 and 2):
- Cardiovascular abnormalities: Heart Rate \> 85% of age-predicted maximal heart rate, systolic blood pressure (SBP) \> 165 millimetre of mercury (mmHg), diastolic blood pressure \> 110 mmHg during rest OR systolic blood...
- Osteopenia (a T - Score of ≤-2.5 on heel ultrasound). Participants with a score ≤ -2.5 will be advised to seek medical guidance from their physician.
- Loss of protective peripheral sensations (inability to perceive 5.07/10 g on the Semmes Monofilament testing).
- Global aphasia (A score of \<71% on the Mississippi Aphasia Scoring test)
- Peripheral nerve injuries (traumatic nerve lacerations, pathological nerve damage).
- High fall-risk, \<40/56 on Berg Balance Scale (for Study 2 participants only)
- Inability to walk 1 block with or without an assistive device (for Study 2 participants only)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.