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

Overview

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.

Interventions

• Device 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 concurr
• 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. Th
• 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 sp

Primary outcome measures

• walking speed (m/s) under single-task walking and dual-task walking with the Stroop task [Time frame: baseline, after 4-week intervention, one-month follow-up]
• swing phase asymmetry under single-task walking and dual-task walking with the Stroop task [Time frame: baseline, after 4-week intervention, one-month follow-up]
• stride length asymmetry under single-task walking and dual-task walking with the Stroop task [Time frame: baseline, after 4-week intervention, one-month follow-up]
• cognitive composite score [Time frame: baseline, after 4-week intervention, one-month follow-up]

Secondary outcome measures (6)

• Task-specific dual-task interference [Time frame: baseline, after 4-week intervention, one-month follow-up]
• Automaticity [Time frame: baseline, after 4-week intervention, one-month follow-up]
• 6-minute Walking test, 6MWT [Time frame: baseline, after 4-week intervention, one-month follow-up]
• Stroke impact scale, SIS [Time frame: baseline, after 4-week intervention, one-month follow-up]
• Mini-Balance Evaluation System Test, Mini-BESTest [Time frame: baseline, after 4-week intervention, one-month follow-up]
• Walking ability questionnaire [Time frame: baseline, after 4-week intervention, one-month follow-up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Mackay Memory Hospital — Taipei

Identifiers

NCT: NCT06392945 · NSTC 112-2314B-182-021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗