Improving balance and cognition in people with Multiple Sclerosis

Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis

This study is testing a new balance training program to see if it can help people with Multiple Sclerosis improve their physical and thinking skills.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Drugs / interventions: aducanumab
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06341023 on ClinicalTrials.gov

What this trial studies

This project investigates the effects of a Functional Balance Intervention (FBI) on physical and cognitive symptoms in individuals with Multiple Sclerosis (MS). It consists of two parts: one conducted in a lab setting and the other at home, both utilizing a randomized controlled trial design. A total of 150 participants will be screened, with 120 expected to enroll, and they will be divided into FBI and stretching groups for training sessions twice a week over four months. The study aims to assess improvements in physical function, cognitive abilities, and daily living activities among participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 55-80 with a self-reported diagnosis of Multiple Sclerosis who have stable disease-modifying therapy and specific mobility impairments.

Not a fit: Patients with other neurological or systemic conditions that affect mobility, or those who have received physical or occupational therapy in the past six months, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could enhance balance and cognitive function, improving the quality of life for patients with Multiple Sclerosis.

How similar studies have performed: While there is existing evidence supporting exercise interventions for physical function in MS, this specific dual-focus approach on both physical and cognitive symptoms is relatively novel.

Eligibility criteria

Inclusion criteria:

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 diagnosis, all conditions that except Multiple Sclerosis that can directly impact individual's ability to stand and walk.
* 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 impairment.
* 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, language, attention/processing speed, executive function, visuospatial abilities) on the established criteria named "Jak / Bondi" criteria.
* Must be physically inactive, a score \<14 on the questionnaire named "Godin leisure time" questionnaire.

Exclusion Criteria:

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. Individuals who are enrolled in any AD disease modifying drugs trials that might interfere with testing/training or affect the ability to understand instructions will also be excluded.
* 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 participants will be excluded from participation, and further advised to seek medical guidance from their physician.
* 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 the physician.
* 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 pressure \< 90 mmHg and/or mean arterial blood pressure \< 65 mmHg OR oxygen saturation \< 95% during rest.
* 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)

Where this trial is running

Chicago, Illinois

• University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Tanvi Bhatt, PhD — University of Illinois at Chicago
• Study coordinator: Rudri Purohit, MS

Conditions Multiple Sclerosis; Functional Balance; Cognition; Dual task; Physical function; Muscular strength; Spasticity; Sensorimotor dysfunction