Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes.

NCT06362512 | Recruiting

• 1 other identifier: Marco_PANG_2024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity.

Conditions

Stroke

Keywords

Dual-task training; Cognitive-motor interference

Outcome Measures

Primary Outcomes (2)

• Dual-task step frequency

  step frequency under dual-task condition will be recorded

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

• Dual-task cognitive performance accuracy

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

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

Secondary Outcomes (4)

• Blood oxygenation level changes of the brain

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

• Dual-task No.steps

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

• Dual-task correct reaction time

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

• Dual-task amplitude of ankle movement

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

Other Outcomes (10)

• Single-task walking speed

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

• Dual-task walking performance

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

• Mini Balance Evaluation Systems Test

  before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training

Study Arms (3)

dual-task group

EXPERIMENTAL

patients receive three dual motor-cognitive exercise training per week for six weeks.

Behavioral: Dual-task training

single-task group

ACTIVE COMPARATOR

Patients receive three separate cognitive and mobility exercises per week for six weeks.

Behavioral: Single-task training

control group

ACTIVE COMPARATOR

Patients receive three upper limb muscle strengthening exercise with muscle stretching per week for six weeks.

Behavioral: Upper limb strengthening exercise

Interventions

Dual-task training BEHAVIORAL

participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks.

dual-task group

Single-task training BEHAVIORAL

participants receive 30-minute single motor tasks with 30-minute single cognitive tasks three times per week for six consecutive weeks.The cognitive and mobility exercises will be the same as those in the dual-task group, but they will be performed separately.

single-task group

Upper limb strengthening exercise BEHAVIORAL

participants receive upper limb strengthening exercise for 30 minutes and flexibility exercises for 30 minutes three times per week for six consecutive weeks. The training is performed in sitting or standing position and no cognitive load will be added.

control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of stroke, Stroke onset of more than 6 months Aged 50 or more Capable of following verbal instructions Having a Montreal Cognitive Assessment score≥22, Able to walk for 1 minute without physical assistance Not receiving any formal rehabilitation training Having a Fugl-Meyer Ankle dorsiflexion-standing position score≥1

You may not qualify if:

• Contraindications to exercise (e.g., unstable angina) Contraindications to MRI (e.g., pacemaker) Color blindness Neurological disorders Gait-precluding pain Comorbidity

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 000000, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Marco Yiu Chung PANG, PhD

CONTACT

+852 2766-7156; Marco.Pang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This will be a single-blinded randomized controlled trial . The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: June 17, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From Dec 2026 onwards
• Access Criteria: By contacting the Principal Investigator (Prof. Marco PANG): Marco.Pang@polyu.edu.hk

Locations

CN (1)