NCT06341023

Functional Balance Intervention in Multiple Sclerosis

Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis
University of Illinois at Chicago·ClinicalTrials.gov·behavioralNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Multiple Sclerosis
Drug/Device/Intervention
Functional Balance Intervention
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
University of Illinois at Chicago
Location
Chicago, United States of America
Timeline & enrollment
Phase
N/A
Start date
Jun 14, 2024
End date
Jan 09, 2027
Enrollment
120 participants
Primary outcome

Change in physical function,Change in cognitive function,Change in dual task balance performance,Change in dual task gait performance,Change in measured community mobility,Change in self-reported community mobility,Change in self-reported quality of Life

Summary

This project involves two sub-parts:
 
 Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive
 symptoms of Multiple Sclerosis.
 
 Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple
 Sclerosis.
 
 Each study involves a 2-arm, Phase-1, randomized controlled clinical trial to evaluate the
 effect of FBI on physical, cognitive function, and daily living among people with MS (PwMS).
 Study 1 is conducted in a lab setting, while Study 2 is conducted at home with additional
 safety measures. A total of 150 people with multiple sclerosis will be recruited and
 telephone screened, with an expected enrollment of 120 (60 per phase). After in-person
 screening, 96 eligible participants (48 per phase) will undergo pre-training assessment and
 randomization into FBI or Stretching groups. Training sessions will occur twice a week for
 four months. Anticipating a 15-17% attrition rate, the target sample size is 80 (40 per
 phase) for completion of the study. Post-training assessments will be conducted after four
 months to evaluate FBI's impact on physical and cognitive functions. This evidence-based
 protocol, previously successful with neurological and older adult populations, intends to
 provide a low-cost, safe, and effective intervention for PwMS in clinical and community
 settings, including rural areas.

ICD-10 classifications
Multiple sclerosisProgressive systemic sclerosisSystemic sclerosisSystemic sclerosis, unspecifiedDiffuse sclerosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06341023
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06341023 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Illinois at Chicago and is currently Not yet recruiting. The study focuses on Multiple Sclerosis. Target enrollment is 120 participants.

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