Effects of Three Types of Dual-task Interventions on Dual-task Walking Performance of Stroke Patients

NCT03614195 | Completed

• 1 other identifier: 201701988A3
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 gait parameter is gait speed (cm/s) under dual-task walking conditions using the 10 Meter Walking Test.

  10 minutes

• composite score

  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

Secondary Outcomes (8)

• Berg Balance Scale (BBS).

  5-10 minutes

• Mini-Balance Evaluation Systems Test (Mini-BESTest).

  10 minutes

• Timed Up and Go Test (TUG)

  2 minutes

• Functional Gait Assessment (FGA).

  10 minutes

• Activity-specific Balance Confidence Scale (ABC).

  2 minutes

Study Arms (3)

MCDTT

EXPERIMENTAL

The MCDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks.

Device: MCDTT

MDTT

ACTIVE COMPARATOR

The MDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks.

Device: MDTT

CDTT

ACTIVE COMPARATOR

The CDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks.

Device: CDTT

Interventions

MCDTT DEVICE

The MCDTT group will undertake sitting to standing, standing balance, and treadmill walking training while concurrently perform motor and cognitive tasks.

MCDTT

MDTT DEVICE

The MDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only motor task.

MDTT

CDTT DEVICE

The CDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only cognitive task.

CDTT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) first-ever stroke with onset duration more than 3 months
• (2) able to walk 10 m
• (3) no severe vision, hearing, 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 \< 24 on Mini-Mental State Examination)
• severe uncorrected visual deficits.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 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 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 31, 2018
• First Posted: August 3, 2018
• Study Start: October 24, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)