Recruiting

Functional Balance Intervention

Sponsor:

University of Illinois at Chicago

Code:

NCT07355387

Conditions

Multiple Sclerosis

Multiple Sclerosis (MS) - Relapsing-remitting

Multiple Sclerosis (MS) Primary Progressive

Multiple Sclerosis (MS) Secondary Progressive

Multiple Sclerosis Acute and Progressive

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Multicomponent balance intervention consisting of four components including dual-tasking, functional strength, vestibular and dynamic balance.

Stretching

Study Details

Brief summary:

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

Multiple Sclerosis

Multiple Sclerosis (MS) - Relapsing-remitting

Multiple Sclerosis (MS) Primary Progressive

Multiple Sclerosis (MS) Secondary Progressive

Multiple Sclerosis Acute and Progressive

Study ID

NCT07355387

Start date

Nov 24, 2025

Status verified date

Nov, 2025

Completion date

Nov 24, 2027

Anticipated

Primary completion date

Nov 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

Telephone Screening Inclusion Criteria:

1. Age 40-90 years.
2. Self-reported diagnosis of Multiple Sclerosis.
3. On stable disease-modifying therapy for ≥6 months.
4. No PT/OT balance-related therapy in the past 6 months.
5. Able to stand from a chair independently (with or without hand support).
6. Score 25-75% on the 12-item MS Walking Scale.
7. No other neurological, cardiopulmonary, musculoskeletal, or systemic conditions affecting standing/walking.
8. English speaking.
9. Willing to complete all study procedures including Zoom sessions.
10. Has reliable internet access.
11. Has a helper buddy available for all sessions.
12. Possible mild cognitive impairment based on self-report.

Initial Screening Inclusion Criteria:

1. Moderate disability: ePR-EDSS score 4.0-6.5.
2. Mild cognitive impairment: MoCA 18-25, or Jak/Bondi criteria for those scoring 26-30.
3. Physically inactive or moderately active (Godin score <24).
4. Cardiovascular safety parameters within acceptable limits.
5. No global aphasia (Mississippi Aphasia Screening Test ≥71 percent).
6. Berg Balance Scale score ≥40/56.
7. Able to walk 1 block with or without an assistive device.

Helper Buddy Inclusion Criteria:

1. Age ≥18 years.
2. Lives within close proximity to the participant.
3. No self-reported major medical conditions limiting safety assistance.
4. English speaking.
5. Able to attend all training and assessment sessions.
6. Able to assist with basic safety, positioning, and communication with the research team.
7. Has internet access and can use Zoom.

Exclusion Criteria

Telephone Screening Exclusion Criteria:

1. MS relapse or exacerbation within the past 3 months.
2. Recent major surgery (<6 months) or hospitalization (<3 months).
3. Resting shortness of breath or uncontrolled pain >3/10.
4. Uncontrolled hypertension or diabetes.
5. Bone fracture in the past 6 months.
6. Disability limiting activities of daily living.
7. History of epilepsy or uncontrolled seizures in past year.
8. Sedative medication use that may interfere with training.
9. Use of Alzheimer's/dementia-modifying drugs or enrollment in AD clinical trials.
10. Use of antidepressants or anxiety medications.
11. Moderate or high risk on PAR-Q (≤1 "yes" response).
12. Severe cognitive impairment (TICS-M ≥18).
13. Currently receiving cognitive or physical rehabilitation.
14. Pacemaker use.

Initial Screening Exclusion Criteria:

1. Cardiovascular parameters outside safety limits (HR, BP, O₂ saturation).
2. Global aphasia (Mississippi <71 percent).
3. Peripheral nerve injury.
4. Berg Balance Scale <40/56.
5. Inability to walk one block with or without an assistive device.

Population Exclusions:

1. Non-English speakers (protocol delivered only in English).
2. Individuals under 18 years.
3. Pregnant individuals.
4. Prisoners or other vulnerable populations.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Multicomponent balance intervention consisting of four components including dual-tasking, functional strength, vestibular and dynamic balance.

The Functional Balance Intervention (FBI) is a multicomponent, home based cognitive motor training program designed specifically for persons with Multiple Sclerosis. It integrates four structured constructs-functional agility, functional strength, dual task cognitive motor exercises, and vestibular training-within each 1 hour session. The program uses custom designed interactive dual task stepping games that require simultaneous motor stepping responses and cognitive tasks such as arithmetic, category fluency, and visuospatial cue discrimination. Vestibular components include gaze stabilization, head turn walking, and figure of eight patterns. Progression is individualized using predefined home evaluation criteria (step count, chair stands, tandem stance, single leg stance, and perceived stability). Training is completed independently at home with a helper buddy present and supported by weekly Zoom sessions.

Stretching

The stretching program is a non-progressive, home based flexibility protocol designed to serve as an active control condition. Unlike the Functional Balance Intervention, this program does not include agility, strength, dual task, vestibular, or cognitive motor components, and it does not use computerized games or progressive home evaluations. Participants complete 1 hour sessions, 2 days per week for 4 months, consisting solely of static stretches targeting major upper extremity, lower extremity, trunk, and back muscle groups. All stretches are performed in standing to match the positional demands and session duration of the experimental arm without engaging balance or cognitive systems. The program emphasizes gentle range of motion, posture, breathing, and relaxation rather than neuromotor challenge. No equipment is required beyond the printed stretching manual, and exercises do not progress in complexity or intensity.

Primary outcome measure

  • Safety: occurrence of adverse events [ Time Frame: Last week of training (Month 4) ]
  • Adherence [ Time Frame: End of training (Month 4) ]
  • Change in Physical Function measured by Short Physical Performance Battery [ Time Frame: Baseline, 1 week post-training ]
  • Change in Walking Function: Dynamic Gait Index (DGI) [ Time Frame: Baseline, 1 week post-training ]
  • Change in Walking endurance: Timed 25-Foot Walk [ Time Frame: Baseline, 1 week post-training ]
  • Change in information processing speed [ Time Frame: Baseline, 1 week post-training ]
  • Change in verbal learning and memory [ Time Frame: Baseline, 1 week post-training ]
  • Change in visuospatial learning and memory [ Time Frame: Baseline, 1 week post-training ]
  • Change in Dual-task balance cost [ Time Frame: Baseline, 1 week post-training ]
  • Change in Community Mobility: University of Alabama Birmingham (UAB) Questionnaire [ Time Frame: Baseline, 1 week post-training ]
  • Change in Community Mobility: Accelerometer [ Time Frame: Baseline, 1 week post-training ]
  • Change in Quality of Life: Multiple Sclerosis Impact Scale (MSIS-29) [ Time Frame: Baseline, 1 week post-training ]
  • Change in Balance Confidence: Activities-Specific Balance Confidence (ABC) [ Time Frame: Baseline, 1 week post-training ]

Central Contacts and Locations

Central contacts

Tanvi Bhatt, PhD

3124139772tbhhat6@uic.edu

Rudri Purohit, PhD

3128773640rpuroh2@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Tanvi Bhatt, PhD

3128773640rpuroh2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jan 21, 2026

Last verified

Nov, 2025

Keywords

  • Home based rehabilitation
  • Telerehabilitation
  • Multiple Sclerosis
  • Mild cognitive impairment
  • functional balance
  • safety monitoring
  • Cognitive motor training
  • vestibular training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-01-21.