Clinical trial NCT06392945: Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training in Individuals With Chronic Stroke
Official title: Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training on Community Walking Capacity, Walking Automaticity, and Social Participation in Individuals With Chronic Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
gait rehabilitation
rhythmic auditory cueing
cognitive training
treadmill
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2024-05-01
Enrollment: 90
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 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.

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.

Primary outcomes:
measure: walking speed (m/s) under single-task walking and dual-task walking with the Stroop task
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: swing phase asymmetry under single-task walking and dual-task walking with the Stroop task
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: stride length asymmetry under single-task walking and dual-task walking with the Stroop task
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: cognitive composite score
timeFrame: baseline, after 4-week intervention, one-month follow-up
Secondary outcomes:
measure: Task-specific dual-task interference
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: Automaticity
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: 6-minute Walking test, 6MWT
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: Stroke impact scale, SIS
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: Mini-Balance Evaluation System Test, Mini-BESTest
timeFrame: baseline, after 4-week intervention, one-month follow-up
measure: Walking ability questionnaire
timeFrame: baseline, after 4-week intervention, one-month follow-up
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: