Actively Recruiting

Phase Not Applicable
Age: 40Years - 90Years
All Genders
NCT07355387

Home Based Functional Balance Intervention for Multiple Sclerosis

Led by University of Illinois at Chicago · Updated on 2026-01-21

75

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.

CONDITIONS

Official Title

Home Based Functional Balance Intervention for Multiple Sclerosis

Who Can Participate

Age: 40Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 40-90 years
  • Self-reported diagnosis of Multiple Sclerosis
  • On stable disease-modifying therapy for at least 6 months
  • No physical or occupational therapy balance-related therapy in the past 6 months
  • Able to stand from a chair independently with or without hand support
  • Score between 25-75% on the 12-item MS Walking Scale
  • No other neurological, cardiopulmonary, musculoskeletal, or systemic conditions affecting standing or 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
  • Moderate disability with ePR-EDSS score 4.0-6.5
  • Mild cognitive impairment with MoCA 18-25 or Jak/Bondi criteria for scores 26-30
  • Physically inactive or moderately active (Godin score less than 24)
  • Cardiovascular safety parameters within acceptable limits
  • No global aphasia (Mississippi Aphasia Screening Test 71 percent or higher)
  • Berg Balance Scale score 40 or higher out of 56
  • Able to walk 1 block with or without an assistive device

Helper Buddy Inclusion Criteria:

  • Age 18 years or older
  • Lives close to the participant
  • No major medical conditions limiting safety assistance
  • English speaking
  • Able to attend all training and assessment sessions
  • Able to assist with safety, positioning, and communication
  • Has internet access and can use Zoom
Not Eligible

You will not qualify if you...

  • MS relapse or exacerbation within the past 3 months
  • Major surgery within the past 6 months or hospitalization within the past 3 months
  • Resting shortness of breath or uncontrolled pain greater than 3 out of 10
  • Uncontrolled hypertension or diabetes
  • Bone fracture in the past 6 months
  • Disability that limits activities of daily living
  • History of epilepsy or uncontrolled seizures in the past year
  • Use of sedative medications that may interfere with training
  • Use of Alzheimer's/dementia-modifying drugs or enrollment in Alzheimer's clinical trials
  • Use of antidepressants or anxiety medications
  • Moderate or high risk on Physical Activity Readiness Questionnaire (PAR-Q) with one or more "yes" responses
  • Severe cognitive impairment (TICS-M score 18 or lower)
  • Currently receiving cognitive or physical rehabilitation
  • Use of pacemaker
  • Cardiovascular parameters outside safety limits (heart rate, blood pressure, oxygen saturation)
  • Global aphasia (Mississippi Aphasia Screening Test less than 71 percent)
  • Peripheral nerve injury
  • Berg Balance Scale score less than 40 out of 56
  • Inability to walk one block with or without an assistive device
  • Non-English speakers
  • Individuals under 18 years of age
  • Pregnant individuals
  • Prisoners or other vulnerable populations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

T

Tanvi Bhatt, PhD

CONTACT

R

Rudri Purohit, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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