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

Chang Gung University

Status: Enrolling

Conditions: Stroke

Treatments: Device: Treadmill group; Device: Cognitive group; Device: Combined group; Device: Rhythmic group

Study type: Interventional

Funder types: Other

Identifiers

NCT06000644

CMRPD1M0841

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

combined group

Experimental group

Description:

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

Treatment:

Device: Combined group

cognitive group

Active Comparator group

Description:

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

Treatment:

Device: Cognitive group

rhythmic group

Active Comparator group

Description:

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

Treatment:

Device: Rhythmic group

treadmill group

Active Comparator group

Description:

The treadmill group will train only in progressive treadmill walking.

Treatment:

Device: Treadmill group