- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07603102
Mindfulness With Dual-Task Training in Post-Stroke Mild Cognitive Impairment
May 16, 2026 updated by: Jingzhi Zhang, Nanjing Mingzhou Rehabilitation Hospital
Mindfulness Combined With Dual-Task Training for Post-Stroke Mild Cognitive Impairment: A Randomized Controlled Trial
This study aims to investigate whether a combined intervention of mindfulness and dual-task training can improve cognitive function and physical performance in individuals with mild cognitive impairment after stroke.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jingzhi Zhang
- Phone Number: +86-16677137704
- Email: 170787717@qq.com
Study Locations
-
-
-
Nanjing, China
- Recruiting
- Nanjing Mingzhou Rehabilitation Hospital
-
Contact:
- Jingzhi Zhang
- Phone Number: +86-16677137704
- Email: 170787717@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI).
- Time since stroke onset ≥3 months and medically stable.
- Presence of mild cognitive impairment after stroke, defined by a Montreal - - Montreal Cognitive Assessment (MoCA) score < 26.
- Mini-Mental State Examination (MMSE) score ≥ 24.
- Ability to walk independently with or without an assistive device for at least 10 meters.
- Stable medication regimen for at least 4 weeks prior to enrollment.
- Ability to understand study instructions and provide written informed consent.
Exclusion Criteria:
- Severe aphasia, visual impairment, hearing impairment, or communication disorders that interfere with assessment or training participation.
- Severe depression or other major psychiatric disorders.
- Other neurological diseases affecting cognition or movement (e.g., Parkinson's disease, multiple sclerosis, traumatic brain injury).
- Severe musculoskeletal, cardiovascular, or systemic diseases that contraindicate exercise participation.
- Participation in other structured cognitive or rehabilitation intervention programs within the past 3 months.
- Unstable medical condition or recurrent stroke during the study period.
- Inability to safely complete the training protocol as determined by the study investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MDT group
Mindfulness + Dual-Task Training
|
Guided by a professional mindfulness instructor, participants engage in mindfulness meditation to enhance attention, emotional regulation, and cognitive readiness.
The training includes breath awareness, body scan, and present-moment awareness, delivered through guided meditation.Other Name:
Dual-task training is a rehabilitation approach that targets cognitive-motor integration by requiring participants to perform a motor task and a cognitive task simultaneously.
Examples include walking while performing mental calculations, memory tasks, or reaction-based exercises.
The training is progressively adjusted by increasing task difficulty and cognitive load to improve attention allocation, executive function, and dual-task performance in daily activities.
|
|
Experimental: DT group
Dual-Task Training + Health Education
|
Dual-task training is a rehabilitation approach that targets cognitive-motor integration by requiring participants to perform a motor task and a cognitive task simultaneously.
Examples include walking while performing mental calculations, memory tasks, or reaction-based exercises.
The training is progressively adjusted by increasing task difficulty and cognitive load to improve attention allocation, executive function, and dual-task performance in daily activities.
Health education is a non-exercise control intervention designed to provide participants with knowledge related to post-stroke health management.
Topics include stroke recovery, healthy lifestyle behaviors, nutrition, medication adherence, daily activity management, and psychological well-being.
The intervention is delivered through structured educational sessions or instructional materials and does not include active physical or cognitive training components.
|
|
Experimental: AT group
Aerobic Training + Health Education
|
Health education is a non-exercise control intervention designed to provide participants with knowledge related to post-stroke health management.
Topics include stroke recovery, healthy lifestyle behaviors, nutrition, medication adherence, daily activity management, and psychological well-being.
The intervention is delivered through structured educational sessions or instructional materials and does not include active physical or cognitive training components.
Dual-task training is a rehabilitation approach that targets cognitive-motor integration by requiring participants to perform a motor task and a cognitive task simultaneously.
Examples include walking while performing mental calculations, memory tasks, or reaction-based exercises.
The training is progressively adjusted by increasing task difficulty and cognitive load to improve attention allocation, executive function, and dual-task performance in daily activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
The Montreal Cognitive Assessment (MoCA) is a widely used neuropsychological tool for detecting mild cognitive impairment (MCI).
It assesses multiple cognitive domains, including attention, executive function, memory, language, visuospatial ability, abstraction, calculation, and orientation.
The total score is 30 points, with higher scores indicating better cognitive function.
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
May 16, 2026
First Submitted That Met QC Criteria
May 16, 2026
First Posted (Actual)
May 22, 2026
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 16, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Stroke
- Cognitive Dysfunction
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Cognitive Behavioral Therapy
- Mindfulness
Other Study ID Numbers
- NJKF202605002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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