Clinical trial NCT06129227: Brain Activity Changes After Structured Cognitive-motor Exercise for People With Stroke
Official title: Using Functional Near-infrared Spectroscopy to Study the Changes in Brain Activity During Dual-task Walking and the Effects of Structured Cognitive-motor Exercise in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Dual-task training
Cognitive-motor interference
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2023-11-13
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: To assess the effects of a dual-task exercise program on cognitive-motor interference during dual-task walking and the associated changes in brain activity.

Detailed description: Stroke is one of the leading causes of chronic disability in Hong Kong and other parts of the world. Mobility dysfunctions are among the most common impairments observed after stroke. Restoration of mobility is also a top priority in rehabilitation goal-setting by stroke patients. In daily life, functional ambulation in the community requires the ability to maintain walking balance while simultaneously engaging in other attention-demanding tasks (i.e., dual-tasking), such as walking when holding a conversation, or crossing the street while attending to traffic signals. There is increasing evidence that performing a cognitive task in conjunction with a mobility task would cause more severe degradation of one or both tasks among stroke patients when compared with age-matched able-bodied individuals. This phenomenon, termed "cognitive-motor interference", should warrant detailed study, since it has an important impact on community-living among people with stroke.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke confirmed by brain scan reports
* Community-living
* Stroke onset ≥ 6 months
* Aged 50 years or older
* Modified Rankin scale 1-3
* Capable of following verbal instructions
* Montreal Cognitive Assessment score ≥ 22
* Ability to walk for 1 min independently with or without a walking aid
* Not receiving formal rehabilitation elsewhere

Exclusion Criteria:

* Other neurological disorders
* Pain or other comorbidities that seriously affect the ability to walk
* Contraindications to exercise (e.g., angina).

Primary outcomes:
measure: Dual-task gait speed
timeFrame: Through study completion, an average of 1 year
measure: Dual-task cognitive performance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Dual-task gait performance 1
timeFrame: Through study completion, an average of 1 year
measure: Dual-task gait performance 2
timeFrame: Through study completion, an average of 1 year
measure: Dual-task gait performance 3
timeFrame: Through study completion, an average of 1 year
measure: Oxyhemoglobin concentration changes of the brain
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Single-task walking speed
timeFrame: Through study completion, an average of 1 year
measure: Balance 1
timeFrame: Through study completion, an average of 1 year
measure: Balance 2
timeFrame: Through study completion, an average of 1 year
measure: Cognitive performance
timeFrame: Through study completion, an average of 1 year
measure: Cognitive performance 1
timeFrame: Through study completion, an average of 1 year
measure: Cognitive performance 2
timeFrame: Through study completion, an average of 1 year
measure: Fall incidence
timeFrame: Through study completion, an average of 1 year
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Marco Yiu Chung PANG, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong Polytechnic University
name: Xun LI, MSc
role: STUDY_DIRECTOR
References: