NCT07603102

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
May 2026Nov 2026

Study Start

First participant enrolled

May 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 16, 2026

Last Update Submit

May 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA)

    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

Study Arms (3)

MDT group

EXPERIMENTAL

Mindfulness + Dual-Task Training

Other: mindfulnessDevice: Dual-Task Training

DT group

EXPERIMENTAL

Dual-Task Training + Health Education

Device: Dual-Task TrainingOther: Health education

AT group

EXPERIMENTAL

Aerobic Training + Health Education

Device: Aerobic TrainingOther: Health education

Interventions

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:

MDT group

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.

DT groupMDT group

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.

AT group

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.

AT groupDT group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Mingzhou Rehabilitation Hospital

Nanjing, China

RECRUITING

MeSH Terms

Conditions

StrokeCognitive Dysfunction

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
supervisor technician

Study Record Dates

First Submitted

May 16, 2026

First Posted

May 22, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations