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New treatment option for Multiple Sclerosis
Official title Home Based Functional Balance Intervention for Multiple Sclerosis
ClinicalTrials.gov ID: NCT07355387
What this study is testing
- What it's testing
- The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group).
- 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 40 to 90
You may be able to join if
- Telephone Screening
- Age 40-90 years.
- Self-reported diagnosis of Multiple Sclerosis.
- On stable disease-modifying therapy for ≥6 months.
- No PT/OT balance-related therapy in the past 6 months.
You likely can't join if
- Telephone Screening Exclusion Criteria:
- MS relapse or exacerbation within the past 3 months.
- Recent major surgery (\<6 months) or hospitalization (\<3 months).
- Resting shortness of breath or uncontrolled pain \>3/10.
- Uncontrolled hypertension or diabetes.
- Bone fracture in the past 6 months.
See the full eligibility criteria
- Telephone Screening
- Age 40-90 years.
- Self-reported diagnosis of Multiple Sclerosis.
- On stable disease-modifying therapy for ≥6 months.
- No PT/OT balance-related therapy in the past 6 months.
- Able to stand from a chair independently (with or without hand support).
- Score 25-75% on the 12-item MS Walking Scale.
- No other neurological, cardiopulmonary, musculoskeletal, or systemic conditions affecting standing/walking.
- English speaking.
- Willing to complete all study procedures including Zoom sessions.
- Has reliable internet access.
- Has a helper buddy available for all sessions.
- Possible mild cognitive impairment based on self-report. Initial Screening
- Moderate disability: ePR-EDSS score 4.0-6.5.
- Mild cognitive impairment: MoCA 18-25, or Jak/Bondi criteria for those scoring 26-30.
- Physically inactive or moderately active (Godin score \<24).
- Cardiovascular safety parameters within acceptable limits.
- No global aphasia (Mississippi Aphasia Screening Test ≥71 percent).
- Berg Balance Scale score ≥40/56.
- Able to walk 1 block with or without an assistive device. Helper Buddy
- Age ≥18 years.
- Lives within close proximity to the participant.
- No self-reported major medical conditions limiting safety assistance.
- English speaking.
- Able to attend all training and assessment sessions.
- Able to assist with basic safety, positioning, and communication with the research team.
- Has internet access and can use Zoom.
- Telephone Screening Exclusion Criteria:
- MS relapse or exacerbation within the past 3 months.
- Recent major surgery (\<6 months) or hospitalization (\<3 months).
- Resting shortness of breath or uncontrolled pain \>3/10.
- Uncontrolled hypertension or diabetes.
- Bone fracture in the past 6 months.
- Disability limiting activities of daily living.
- History of epilepsy or uncontrolled seizures in past year.
- Sedative medication use that may interfere with training.
- Use of Alzheimer's/dementia-modifying drugs or enrollment in AD clinical trials.
- Use of antidepressants or anxiety medications.
- Moderate or high risk on PAR-Q (≤1 "yes" response).
- Severe cognitive impairment (TICS-M ≥18).
- Currently receiving cognitive or physical rehabilitation.
- Pacemaker use. Initial Screening Exclusion Criteria:
- Cardiovascular parameters outside safety limits (HR, BP, O₂ saturation).
- Global aphasia (Mississippi \<71 percent).
- Peripheral nerve injury.
- Berg Balance Scale \<40/56.
- Inability to walk one block with or without an assistive device. Population Exclusions:
- Non-English speakers (protocol delivered only in English).
- Individuals under 18 years.
- Pregnant individuals.
- Prisoners or other vulnerable populations.
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, 40 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.