Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke

NCT ID: NCT06000644

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to compare the effects of progressive combined cognitive training and rhythmic auditory stimulation to treadmill training (combined group), cognitive treadmill training (cognitive group), rhythmic auditory stimulation to treadmill training (rhythmic group), and treadmill walking alone (treadmill group) on walking automaticity, executive function, and dual-task coordination for patients with chronic stroke (Aim 1). The second aim of this study is to investigate the factors affecting the results of interventions (Aim 2). The third aim of the study is to examine the characteristics of stroke population who are appropriate for progressive combined cognitive training and rhythmic auditory stimulation to treadmill training.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A single-blinded, randomized controlled trial will be conducted at medical centers. Eighty stroke patients will be randomized to one of the four 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 and rhythmic auditory stimulation while performing a cognitive task. The cognitive group will receive cognitive training while walking on the treadmill. The rhythmic group will hear rhythmic auditory stimulation while treadmill walking. The treadmill group will train only in progressive treadmill walking. 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 of gait and cognition are gait speed and cognitive score of the Stroop task under single- and dual-task conditions. The secondary outcome measures are the Mini-BESTest, Walking Ability Questionnaire, 6-minute Walk Test, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between and within the groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

combined group

The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing.

Group Type EXPERIMENTAL

Combined group

Intervention Type DEVICE

The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing for 30 minutes per session, 3 times a week for 4 weeks.

cognitive group

The cognitive group will receive cognitive training while walking on the treadmill.

Group Type ACTIVE_COMPARATOR

Cognitive group

Intervention Type DEVICE

The cognitive group will receive cognitive training while treadmill walking with a progressive speed for 30 minutes per session, 3 times a week for 4 weeks .

rhythmic group

The rhythmic group will hear rhythmic auditory stimulation while treadmill walking.

Group Type ACTIVE_COMPARATOR

Rhythmic group

Intervention Type DEVICE

The rhythmic group will hear rhythmic auditory stimulation while treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.

treadmill group

The treadmill group will train only in progressive treadmill walking.

Group Type ACTIVE_COMPARATOR

Treadmill group

Intervention Type DEVICE

The treadmill group will train only in progressive treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Combined group

The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing for 30 minutes per session, 3 times a week for 4 weeks.

Intervention Type DEVICE

Cognitive group

The cognitive group will receive cognitive training while treadmill walking with a progressive speed for 30 minutes per session, 3 times a week for 4 weeks .

Intervention Type DEVICE

Rhythmic group

The rhythmic group will hear rhythmic auditory stimulation while treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.

Intervention Type DEVICE

Treadmill group

The treadmill group will train only in progressive treadmill walking for 30 minutes per session, 3 times a week for 4 weeks.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. orthopedic problems affecting walking or other diseases that may interfere with study participation;
2. a score of less than 24 on the mini-mental state examination (MMSE);
3. 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

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Li-Ling Chuang

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li-Ling Chuang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mackay Memory Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Li-Ling Chuang, Ph.D.

Role: CONTACT

886-3-2118800 ext. 3177

Li-Ling Chuang, Ph.D.

Role: CONTACT

886-3-2118800 ext. 3177

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Li-Ling Chuang, Ph.D.

Role: primary

886-3-2118800 ext. 3177

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMRPD1M0841

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.