Clinical trial NCT06000644: Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke
Official title: Effects of Progressive Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training on Walking Automaticity, Executive Function, and Dual-task Coordination for Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
gait rehabilitation
rhythmic auditory stimulation
cognitive training
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Walking speed (m/s)
timeFrame: 5 minutes
measure: Stride time variability (%)
timeFrame: 5 minutes
measure: Gait asymmetry (%)
timeFrame: 5 minutes
measure: Cognitive composite score
timeFrame: 5 minutes
Secondary outcomes:
measure: Dual-task automaticity
timeFrame: 5 minutes
measure: Task-specific dual-task interference
timeFrame: 5 minutes
measure: 6-minute Walking test, 6MWT
timeFrame: 6 minutes
measure: Stroke impact scale, SIS
timeFrame: 10 minutes
measure: Mini-Balance Evaluation System Test, Mini-BESTest
timeFrame: 10 minutes
measure: Walking ability questionnaire
timeFrame: 5 minutes
measure: Outdoor walking assessment
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memory Hospital
Study officials:
affiliation: Chang Gung University
name: Li-Ling Chuang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: