NCT06769672

Brief Summary

The purpose of this study is to evaluate tDCS combined with cognitive-motor training on dual-task interference during dual-task walking, dual-task foot pedaling and the corresponding alterations of brain activity.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
8mo left

Started Jan 2025

Typical duration 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 Progress67%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 10, 2026

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

January 6, 2025

Last Update Submit

February 6, 2026

Conditions

Keywords

Dual-task trainingCognitive-motor interferencetDCS

Outcome Measures

Primary Outcomes (2)

  • Dual-task gait speed

    Gait speed under dual-task condition will be recorded

    Through study completion, an average of 1 year

  • Dual-task cognitive performance

    Number of correct responses will be measured during dual-task conditions

    Through study completion, an average of 1 year

Secondary Outcomes (9)

  • Oxyhemoglobin concentration changes of the brain

    Through study completion, an average of 1 year

  • Dual-task gait performance 1

    Through study completion, an average of 1 year

  • Dual-task gait performance 2

    Through study completion, an average of 1 year

  • Dual-task gait performance 3

    Through study completion, an average of 1 year

  • Dual-task cognitive performance 1

    Through study completion, an average of 1 year

  • +4 more secondary outcomes

Other Outcomes (11)

  • Dual-task peak angular velocity

    Through study completion, an average of 1 year

  • Dual-task cognitive performance 3

    Through study completion, an average of 1 year

  • Single-task walking speed

    Through study completion, an average of 1 year

  • +8 more other outcomes

Study Arms (2)

active tDCS combined with dual-task group

EXPERIMENTAL

patients receive three active tDCS and three dual motor-cognitive exercise training per week for four weeks.

Other: active tDCS with dual-task training

sham tDCS combined with dual-task group

ACTIVE COMPARATOR

Patients receive three sham tDCS and three dual cognitive-motor exercise training per week for four weeks.

Other: sham tDCS with dual-task training

Interventions

participants receive three 20-minute active tDCS treatment and three 60-minute COGMOTION dual-task exercise sessions per week for four consecutive weeks.

active tDCS combined with dual-task group

participants receive three 20-minute sham tDCS treatment and three 60-minute COGMOTION dual-task exercise sessions per week for four consecutive weeks.

sham tDCS combined with dual-task group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a diagnosis of stroke, stroke onset of more than 6 months,
  • aged 50 or more,
  • capable of following verbal and visual instructions,
  • having a Montreal Cognitive Assessment score ≥ 22,
  • able to walk for 10 meters with/without a mobility aid,
  • community-dwelling, unilateral stroke

You may not qualify if:

  • neurological disorders, gait-precluding pain or comorbidity,
  • receiving any formal rehabilitation training,
  • contraindications to exercise (e.g., unstable angina),
  • contraindications to fNIRS, MRI, and tDCS (e.g., brain skin injury, pacemaker, metal implants in the brain),
  • history of seizure or epilepsy,
  • color blindness.
  • unable to walk with/without a mobility aid while responsing stimulus by the remote control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 10, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 10, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

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