Comparative Efficacy of Two Different Dual-task Balance Interventions
Condition: Stroke; Healthy Older Adults
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effects of two different dual-task balance
      interventions for stroke patients and older adults.
    

Detailed description: 
      English Synopsis

      I. Title of Study:

      Comparative efficacy of two different dual-task balance interventions on balance, gait, and
      cognitive performance under single- and dual-task conditions in stroke patients and older
      adults

      II. Study Objectives:

      The objective of this study is to investigate the effects of two different dual-task balance
      interventions for stroke patients and older adults. Specifically, the investigators will
      compare the immediate and retention effects of motor and cognitive dual-task balance training
      [MCDT] and cognitive dual-task balance training [CDT]) on balance, gait, and cognition under
      single- and dual-task conditions in individuals with stroke (Aim 1) and elderly people (Aim
      2). The third aim of this study is to elucidate the mechanisms underlying changes in balance,
      gait, and cognitive performance of stroke patients and older adults after MCDC and CDT (Aim
      3).

      III. Study Design A prospective randomized control trial will be conducted at medical centers
      in this study. Fifty stroke patients and 48 elderly people will be randomly allocated to
      either MCDT or CDT group. Both groups will receive 12 hours of training over 4 weeks at
      progressively increasing task difficulty (60 minutes per session, three times a week, for
      four weeks). The CDT group will undertake dual-task balance training and concurrently perform
      only cognitive tasks with instruction of a variable priority. The MCDT group will train the
      same set of balance/gait activities as the CDT while simultaneously performing motor and
      cognitive tasks with instruction of a variable priority. During each session, all
      participants practice shifting attention between tasks by spending half of the training
      attention focus on the balance task, and half focus on the secondary cognitive or motor
      tasks. A blinded assessor will conduct three assessments at baseline, post intervention, and
      1-month follow-up. At baseline, all participants will be examined balance, gait, and
      cognitive performance under single-task (standing, walking, cognitive tasks only) and
      dual-task conditions (standing/walking while performing cognitive tasks). Six cognitive tasks
      (simple reaction time task, serial three subtractions task, Stroop task, auditory Stroop
      task, spatial memory task, and choice reaction time task) will be used to examine dual-task
      performance because these tasks represent different domains of cognitive function
      (information processing speed, working memory, and executive function). The primary outcome
      measure of balance, gait, and cognition will be the sway index, gait speed, and composite
      score of accuracy and reaction time under single- and dual-task conditions. Secondary outcome
      measures will include: Berg Balance Scale, Timed Up and Go test under single- and dual-task
      conditions, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair
      Stand Test, and Patient Global Impression of Change. Repeated measure ANOVA will be used to
      compare measurements at baseline, after training, and follow-up between the groups.

      Number of Planned Patients: 50 stroke patients and 48 elderly people Duration of the Study:
      2017/08/01～2020/07/31
    

Intervention name(s): motor-cognitive dual-task training; cognitive dual-task training
Intervention type(s): Device; Device
Intervention description(s): Participants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions.; Participants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks.
Other intervention name(s): MCDT; CDT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment