Vestibular Balance-Cognition Dual-Task Digital System: Development of a Smart Rehabilitation Platform for the Elderly and Prediction of Balance Function Risks

Overview

This study is being done to better understand how vestibular problems and thinking abilities (such as attention and mental flexibility) are related in older adults, and how doing a balance task and a thinking task at the same time affects their performance. Older adults will first complete questionnaires and simple paper-and-pencil tests of attention, memory, and mental rotation while seated. They will then perform standing balance tasks on a portable force platform under different conditions (eyes open, eyes closed, standing on a foam surface) and will repeat some of the thinking tasks at the same time. Next, participants will walk on a treadmill while wearing small motion sensors, both with and without added thinking tasks such as serial subtraction and digit reordering. The total testing time is about 90 minutes. Two groups will be included: healthy older adults and older adults who have had dizziness or falls in the past two years. By comparing these groups, the study aims to provide a basis for designing future dual-task assessment and training programs to reduce balance problems and falls in older adults.

Interventions

• Device Instrumented balance and gait assessment using wearable inertial sensors
  Participants undergo a series of static and dynamic balance and gait assessments in a motion analysis laboratory while wearing body-segment inertial measurement units (IMUs). The sensors provide real-time signals for interaction with the evaluation system during single-task and dual-task standing and walking tests.
• Other Questionnaires and paper-based cognitive tests
  Participants complete a battery of self-report questionnaires and paper-based cognitive tests after explanation by a physical therapist. Instruments include dizziness and balance scales, the Activities-specific Balance Confidence (ABC) scale, and cognitive tests such as the WAIS-III Taiwan Digit Odd-Even Sequencing Test, Taiwan Stroop Word-Color Test, path judgment tasks, and mental rotation tasks. Questionnaires are administered verbally and responses recorded in writing.

Primary outcome measures

• Gait speed [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Stride length (m) [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Step width (m) [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Cadence (steps/min) [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Step-to-step variability (%) [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Trunk angular velocity (degrees/s) [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Trunk angular displacement (degrees) [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Center-of-mass displacement (m) [Time frame: Baseline laboratory assessment (single visit in year 1)]
• Response time (s or ms) [Time frame: Baseline laboratory assessment (single visit in year 1)]

Secondary outcome measures (12)

• Montreal Cognitive Assessment-Taiwan version score (0-30points) [Time frame: Baseline laboratory assessment]
• Path tracing completion time (s) [Time frame: Baseline laboratory assessment]
• Stroop test score (count as PR1-99%) [Time frame: Baseline laboratory assessment]
• Working memory completion time (s) [Time frame: Baseline laboratory assessment]
• Mental rotation accuracy (number of correct responses)(0-16) [Time frame: Baseline laboratory assessment]
• Mental rotation completion time (s) [Time frame: Baseline laboratory assessment]
• Activities-specific Balance Confidence score (0-100 points) [Time frame: Baseline laboratory assessment]
• Dizziness Handicap Inventory score (0-100points) [Time frame: Baseline laboratory assessment]
• Hospital Anxiety and Depression Scale - Anxiety score (0-21 points) [Time frame: Baseline laboratory assessment]
• Hospital Anxiety and Depression Scale - Depression score (0-21 points) [Time frame: Baseline laboratory assessment]
• Visual Vertigo Analogue Scale score ( 0-90points) [Time frame: Baseline laboratory assessment]
• Dynamic Gait Index score (0-24 points) [Time frame: Baseline laboratory assessment]

Eligibility criteria

Inclusion criteria

• Community-dwelling adults aged 55 years or older.
• Able to walk at least 30 meters independently or with the use of a walking aid.
• Able to understand the study procedures and communicate in Mandarin or Taiwanese.
• Adequate corrected vision to go out independently.
• Able to participate in 45-minute sessions of moderate-intensity exercise once per week.

Exclusion criteria

• Severe central or peripheral neurological diseases.
• Blindness or deafness.
• Inability to communicate verbally or to understand simple instructions.
• Current fractures or major joint injuries.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Taiwan · 1 center

• National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Tec — Taipei

Identifiers

NCT: NCT07735078 · NYCU114022AF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗