Brain Activity Changes After Structured Cognitive-motor Exercise for People With Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129227
• Other study ID #: P0037680
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: The Hong Kong Polytechnic University
• Contact: Marco Yiu Chung PANG, PhD
• Phone: 2766-7156
• Email: Marco.Pang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Dual-task training
This group will receive 30 min of dual-task exercise training and 30 min of stretching exercises in each session. The dual-task component involves walking activities performed in conjunction with cognitive activities. For the stretching exercise component, no cognitive load will be added.
• Single-task training
This group will undergo 30 min of single-task mobility training and another 30 min of single-task cognitive activities. The cognitive and mobility exercises will be the same as those in the dual-task group, but they will be performed separately. No extra cognitive load will be imposed during the mobility exercises. No additional motor demand will be imposed during the cognitive exercises, as the participants will be sitting.
• Control group
This group will undergo 30 min of stretching exercises (same as the dual-task group) and another 30 min of upper limb strengthening exercises performed primarily in the sitting or lying position. No cognitive load will be added.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Research Grants Council, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single-task walking speed	10-meter walking test will be used to assess single-task walking speed in meters per second	Through study completion, an average of 1 year
Other	Balance 1	Mini Balance Evaluation Systems Test will be used to assess postural control, with total points from 0-28. Higher points indicate better performance.	Through study completion, an average of 1 year
Other	Balance 2	Activities-specific Balance Confidence Scale will be used to assess confidence of functional balance performance, with total points from 0-100. Higher points indicate better performance.	Through study completion, an average of 1 year
Other	Cognitive performance	Stroop color word test will be used to assess executive function	Through study completion, an average of 1 year
Other	Cognitive performance 1	Digit Span Test will be used to assess working memory	Through study completion, an average of 1 year
Other	Cognitive performance 2	Montreal Cognitive Assessment will be used to assess global cognition, with total points from 0-30. Higher points indicate better performance.	Through study completion, an average of 1 year
Other	Fall incidence	Monthly telephone interviews for recording fall incidence	Through study completion, an average of 1 year
Primary	Dual-task gait speed	Gait speed under dual-task condition will be recorded	Through study completion, an average of 1 year
Primary	Dual-task cognitive performance	Number of correct responses will be measured during dual-task walking	Through study completion, an average of 1 year
Secondary	Dual-task gait performance 1	Gait cadence will be measured during dual-task walking	Through study completion, an average of 1 year
Secondary	Dual-task gait performance 2	Stride length will be measured during dual-task walking	Through study completion, an average of 1 year
Secondary	Dual-task gait performance 3	Trunk stability will be measured during dual-task walking	Through study completion, an average of 1 year
Secondary	Oxyhemoglobin concentration changes of the brain	Oxyhemoglobin concentration changes will be measured using functional near infra-red spectroscopy during dual-task walking	Through study completion, an average of 1 year