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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:

‣ Telephone Screening Inclusion Criteria:

• 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 Inclusion Criteria:

• 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 Inclusion Criteria:

• 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.

Locations
United States
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Contact Information
Primary
Tanvi Bhatt, PhD
tbhhat6@uic.edu
3124139772
Backup
Rudri Purohit, PhD
rpuroh2@uic.edu
3128773640
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2027-11-24
Participants
Target number of participants: 75
Treatments
Experimental: Intervention Group
Participants assigned to the Functional Balance Intervention (FBI) will complete a 4 month, home based, multicomponent balance and cognitive motor training program. Sessions occur 2 days per week for 1 hour each and are performed independently at home with a designated helper buddy present for safety. Each session includes randomized blocks of functional agility, functional strength, dual task cognitive motor exercises, and vestibular training. Exercises emphasize dynamic balance, multi joint strength, postural control, attention, processing speed, and visuospatial orientation. Dual task components include custom computer based stepping games that integrate cognitive tasks with functional movements. Vestibular components include gaze stabilization, head turn walking, and figure of eight walking. Exercise difficulty progresses based on predefined home evaluation criteria. Participants receive a training manual, home equipment kit, weekly follow up via Zoom, and safety monitoring.
Active_comparator: Stretching Group
Participants assigned to the stretching program will complete a 4 month, home based flexibility training regimen matched in duration and frequency to the intervention group. Sessions occur 2 days per week for 1 hour each and include progressive stretching of major upper limb, lower limb, core, and back muscle groups. All stretches are performed in standing to match upright time and positional demands of the Functional Balance Intervention. Each session begins with a brief warm up and concludes with a 10 minute cool down emphasizing relaxation and breathing exercises. Participants receive a printed exercise manual detailing weekly schedules, safety precautions, and instructions for each stretch. No specialized equipment or computer based components are required. A helper buddy must remain present during all sessions for safety. Participants also participate in weekly Zoom check ins to monitor adherence, address concerns, and review home safety recommendations.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov