Clinical trial NCT06362512: Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes.
Official title: An Innovative Cognitive-motor Exercise Training (COGMOTION) for People With Stroke: Effects on Balance, Mobility, Falls, Cognition and Related Brain Changes.
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
First posted: 2024-04-12
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: 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.

Detailed description: The prevalence rate of stroke increased by 106.0% (93.7-118.8) from 1990 to 2019 in China, and stroke burden is still severe. Community ambulation is an important factor that influences health-related quality of life after a stroke.In daily living, effective community ambulation requires the ability to maintain balance and walking function while engaging in other tasks that demand attentional resources simultaneously (i.e., dual-tasking). Increasing evidence has shown that stroke patients have more problems with dual-task balance and walking function than their age-matched able-bodied peers. stroke individuals were found to have more reduction in both the walking speed and cognitive recall than control group during walking with remembering a shopping list. Hence, since stroke victims must reintegrate into community, this kind of cognitive-motor interference needs to be thoroughly studied.

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

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

Primary outcomes:
measure: Dual-task step frequency
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Dual-task cognitive performance accuracy
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Secondary outcomes:
measure: Blood oxygenation level changes of the brain
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Dual-task No.steps
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Dual-task correct reaction time
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Dual-task amplitude of ankle movement
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Other outcomes:
measure: Single-task walking speed
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Dual-task walking performance
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Mini Balance Evaluation Systems Test
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Activities-specific Balance Confidence Scale
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Trail Making Test
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Digit Span Test
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Montreal Cognitive Assessment
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Fall incidence
timeFrame: before the initiation of training, 6 months after training
measure: Dual-task ankle movement degree
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
measure: Dual-task cognitive performance time
timeFrame: before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
References: