Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training in Individuals With Chronic Stroke

NCT ID: NCT06392945

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2027-07-31

Brief Summary

The first objective of this study is to examine the superiority of the combined rhythmic auditory cueing with cognitive treadmill training (combined group) in people with stroke as compared with the cognitive treadmill walking training (cognitive group) or treadmill walking training alone (treadmill group) (Aim 1). The study's second aim is to investigate the factors affecting the improvement in community walking capacity after interventions and to explore whether changes in community walking capacity are associated with changes in participation after interventions (Aim 2).

Detailed Description

A single-blind, randomized controlled trial is conducted at medical centers. Ninety stroke patients will be randomized to one of the three groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). The cognitive group will receive cognitive training while walking at a progressive speed on the treadmill. The treadmill-alone group will train only in treadmill walking with progressive speed adjusted weekly. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures are gait and cognition under single- and dual-task conditions. The secondary outcome measures are the 6-minute Walk Test, Mini-BESTest, Stroke Impact Scale, and Walking Ability Questionnaire.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group

The CTW+RAC group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence).

Group Type: EXPERIMENTAL

Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group

Intervention Type: DEVICE

Participants in the CTW+RAC group participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. To increase adaptability to rhythmic auditory cueing prior to cognitive treadmill walking training, participants are required to keep stepping on their feet while listening to the auditory cueing using a metronome program (Metronome APP) for 5 minutes of warm up. Then they start walking on a treadmill with a target speed and perform a cognitive task concurrently while listening rhythmic auditory cueing. According to previous research, the target treadmill speed at week 1, week 2, week 3, and week 4 is gradually increased from 90%, 100%, 110%, to 120% baseline walking speed of comfortable walking on the ground. The beat of rhythmic auditory cueing using the Metronome APP on the smartphone is set at 110% of baseline cadence of comfortable walking on the ground based on a previous study in individuals with stroke.

Cognitive Treadmill Walking Training (CTW)

The CTW group will receive cognitive training while walking at a progressive speed on the treadmill.

Group Type: ACTIVE_COMPARATOR

Cognitive Treadmill Walking Training (CTW) group

Intervention Type: DEVICE

Participants in the CTW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed and perform a cognitive task concurrently without rhythmic auditory cueing. Same cognitive training and target treadmill speed will be used as the CTW+RAC group during cognitive dual-task treadmill walking. Three cognitive training programs will be the verbal fluency, arithmetic, and visual distinguish tasks. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the 10 meters walk test at week 4.

Treadmill Walking Training (TW)

The TW group will train only in treadmill walking with progressive speed adjusted weekly.

Group Type: ACTIVE_COMPARATOR

Treadmill Walking Training (TW)

Intervention Type: DEVICE

Participants in the TW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed only, without concurrent performing a cognitive task and no listening rhythmic auditory cueing. Same target treadmill speed will be used as the other two groups during treadmill walking. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the ground.

Interventions

Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group

Participants in the CTW+RAC group participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. To increase adaptability to rhythmic auditory cueing prior to cognitive treadmill walking training, participants are required to keep stepping on their feet while listening to the auditory cueing using a metronome program (Metronome APP) for 5 minutes of warm up. Then they start walking on a treadmill with a target speed and perform a cognitive task concurrently while listening rhythmic auditory cueing. According to previous research, the target treadmill speed at week 1, week 2, week 3, and week 4 is gradually increased from 90%, 100%, 110%, to 120% baseline walking speed of comfortable walking on the ground. The beat of rhythmic auditory cueing using the Metronome APP on the smartphone is set at 110% of baseline cadence of comfortable walking on the ground based on a previous study in individuals with stroke.

Intervention Type: DEVICE

Cognitive Treadmill Walking Training (CTW) group

Participants in the CTW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed and perform a cognitive task concurrently without rhythmic auditory cueing. Same cognitive training and target treadmill speed will be used as the CTW+RAC group during cognitive dual-task treadmill walking. Three cognitive training programs will be the verbal fluency, arithmetic, and visual distinguish tasks. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the 10 meters walk test at week 4.

Intervention Type: DEVICE

Treadmill Walking Training (TW)

Participants in the TW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed only, without concurrent performing a cognitive task and no listening rhythmic auditory cueing. Same target treadmill speed will be used as the other two groups during treadmill walking. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the ground.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• diagnosed with first-time stroke;
• more than 6 months after stroke onset;
• able to walk 10 meters;
• no severe vision, hearing, or speech impairments;
• understand and follow the instructions and sign the Informed Consent Form;
• older than 20 years old.

Exclusion Criteria

• orthopedic problems affecting walking or other diseases that may interfere with study participation;
• a score of less than 24 on the mini-mental state examination (MMSE);
• severe balance disorder with a total score of less than 45 points Berg Balance Scale.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Li-Ling Chuang

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Ling Chuang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Mackay Memory Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Li-Ling Chuang, Ph.D.

Role: CONTACT

lchunag@gap.cgu.edu.tw

886-3-2118800 ext. 3177

Li-Ling Chuang, Ph.D.

Role: CONTACT

lchuang@mail.cgu.edu.tw

886-3-2118800 ext. 3177

Facility Contacts

Li-Ling Chuang, Ph.D.

Role: primary

lchuang@gap.cgu.edu.tw

886-3-2118800 ext. 3177

Other Identifiers

NSTC 112-2314B-182-021

Identifier Type: -

Identifier Source: org_study_id