Comparative Efficacy of Two Different Dual-task Balance Interventions

NCT03234998 | Completed

• 1 other identifier: 1612190002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Healthy Older Adults

Outcome Measures

Primary Outcomes (4)

• sway index

  Sway index is the standard deviation of the sway angle. The higher the sway index the more unsteady the person was during the test.

  10 minutes

• gait speed

  Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch. The primary outcome measure will be gait speed (cm/s) under single- and dual-task conditions.

  5 minutes

• composite score

  Participants will be asked to perform six different cognitive tasks while sitting, standing, and walking. The order of six cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions. The six cognitive tasks are selected based upon the different domains of cognitive tasks commonly used in previous dual-task studies. For all the cognitive tasks, we will calculate a composite score for cognitive-task performance by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs in the overall dual-task effect.

  10 minutes

• cognitive-motor interference (CMI)

  The effect of dual-tasking on both standing/walking and cognitive parameters will be assessed by comparing any change in performance of balance/gait and cognitive measures between single- and dual-task conditions. We will calculate DTE for gait speed and composite score using following formula: \[(Dual-task - Single-task)/ Single-task \*100\] and for sway index using formula: \[(Single-task - Dual-task)/ Single-task \*100\]. Negative cost (higher cost) indicates poor performance on dual-task conditions compared with single-task conditions.

  20 minutes

Secondary Outcomes (6)

• Berg Balance Scale (BBS)

  5-10 minutes

• Timed Up and Go Test

  2minutes

• Functional Gait Assessment (FGA)

  10 minutes

• Activity-specific Balance Confidence Scale (ABC)

  3 minutes

• Chair Stand Test.

  1 minute

Study Arms (2)

motor-cognitive dual-task training

EXPERIMENTAL

Participants in the motor-cognitive dual-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks.

Device: motor-cognitive dual-task training

cognitive dual-task training

ACTIVE COMPARATOR

Participants in the cognitive dual-task training group will also participate in a 12-session program conducted 60 minutes per session, 3 days a week, for a total of 4 weeks.

Device: cognitive dual-task training

Interventions

motor-cognitive dual-task training DEVICE

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.

Also known as: MCDT

motor-cognitive dual-task training

cognitive dual-task training DEVICE

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.

Also known as: CDT

cognitive dual-task training

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first-ever stroke with onset duration more than 3 months
• able to walk 10 m
• no severe vision, hearing, and language problems
• more than 65 years old
• able to walk 10 m
• no neurological or musculoskeletal diagnosis
• no severe vision, hearing, cognition, and language problems.

You may not qualify if:

• orthopedic and other neurological disorders that affect walking
• other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
• moderate or severe cognitive impairments (score \<21 on Mini-Mental State Examination)
• severe uncorrected visual deficits

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Li-Ling Chuang, PhD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: August 25, 2017
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)