Status unknownNot a drug-phase studyMS (type not specified)NCT06412003

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Home-based balance training

What it measured

Main measures

  • Feasibility outcome: Process

    From enrollment to completion of posttest (12weeks)

    Physical functionQuality of life (reported by participants)Feasibility
  • Feasibility outcome: Resources

    From enrollment to completion of posttest (12weeks)

    Physical functionFeasibility
  • Feasibility outcome: Management

    From enrollment to completion of posttest (12weeks)

    Feasibility
  • Feasibility outcome: Participant burden/satisfaction

    After completion of posttest (12weeks)

    Quality of life (reported by participants)Feasibility
  • Feasibility outcome: Adverse event

    From enrollment to completion of posttest (12weeks)

    SafetyFeasibility
  • Feasibility outcome: Intervention acceptability

    From enrollment to completion of posttest (12weeks)

    Physical functionFeasibility
  • Feasibility outcome: exercise intensity acceptability/compliance

    From enrollment to completion of posttest (12weeks)

    Physical functionFeasibility

Other measures (11)

  • Changes in balance as measured by Timed Up and Go/Dual-task Timed Up and Go

    Baseline and after completion of an intervention (12weeks)

    Thinking and memoryWalking and mobility
  • Changes in functional mobility as measured by 5-time sit-to-stand

    Baseline and after completion of an intervention (12weeks)

    Walking and mobility
  • Changes in static balance as measured by4-stage static balance tests

    Baseline and after completion of an intervention (12weeks)

    Walking and mobility
  • Changes in cognitive function as measured by Brief International Cognitive Assessments for MS (BICAMS)

    Baseline and after completion of an intervention (12weeks)

    Thinking and memory
  • Changes in community mobility perception as measured by Environmental Analysis of Mobility Questionnaire (EAMQ)

    Baseline and after completion of an intervention (12weeks)

    Thinking and memoryWalking and mobilityBladder, bowel and sexual function
  • Changes in fear of falling as measured by Fall Efficacy Scale-International (FES-I)

    Baseline and after completion of an intervention (12weeks)

    Walking and mobility
  • Changes in self-reported walking disability as measured by Multiple Sclerosis Walking Scale-12v2 (MSWS-12v2)

    Baseline and after completion of an intervention (12weeks)

    Walking and mobility
  • Changes in self-reported dual-tasking difficulty as measured by Dual-task Impact on Daily-Living Activities Questionnaire (DIDA-Q)

    Baseline and after completion of an intervention (12weeks)

  • Changes in self-reported fatigue as measured by Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Baseline and after completion of an intervention (12weeks)

    Thinking and memoryFatigue
  • Changes in Real-world ambulation metrics as measured by tri-axial accelerometer

    Baseline and after completion of an intervention (12weeks)

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 75

Inclusion Criteria: * Physician-diagnosed MS * Ages 18-75 years * Patient Determined Disease Steps (PDDS) scale score between 2-5 (i.e., gait disability-late cane) * Able to participate in exercise (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q+)) * Have a webcam on a device at least the size of a full tablet (i.e., larger than a smartphone) * Have an exercise supporter (e.g., spouse or family member) who is willing to participate in the intervention * Not currently participating in any balance-related exercise program Exclusion Criteria: * Cognitively unable to read and sign informed consent form and follow verbally delivered screening assessment * Unable to communicate in English

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This single-group pretest-posttest study aims to examine the feasibility domains in response to 12 weeks of home-based balance training in persons with multiple sclerosis (MS). The feasibility domains include 1) process (e.g., recruitment, attendance, adherence rate), 2) resources (e.g., total monetary costs), 3) management (e.g., assessment time), and 4) scientific outcomes (adverse events, intervention acceptability, satisfaction, treatment effects). Moreover, this study aims to evaluate physical function (i.e., balance, mobility, dual-task ability), cognitive function (i.e., cognitive processing speed, verbal memory, visuospatial memory), real-world ambulation (i.e., gait speed, gait variability, gait quantity), and self-report questionnaires (fatigue, fear of falling, walking disability, dual-tasking difficulty). Our proposed intervention is expected to deliver a feasible and accessible exercise modality for balance and cognitive improvement in persons with multiple sclerosis.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jul 2024

    2. Main results due

      Mar 2025

    3. Finished

      May 2025

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