Clinical trial NCT04545138: Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment
Official title: Effects of Combining Cognitive and Treadmill Training on Cognitive Function and Walking Performance-Exploration in Chronic Stroke Patient With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cognitive Impairment
Keywords: Stroke
Cognitive Impairment
Cognitive and treadmill training
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-stroke cognitive impairment is common in stroke survivors. Cognitive function is related to walking ability. The dual task walking is required for daily activities, however, such ability is even more challenging than single walking for people with stroke. The purpose of present study is to investigate the effects of combining cognitive and treadmill training on cognitive function and dual task walking performance in chronic stroke patients with cognitive impairment.

Detailed description: This is a single-blinded, randomized controlled trial with pre- and post-measurements. 24 subjects will be recruited, and randomly assigned to one of two groups: cognitive training during treadmill training group (experimental group) and treadmill training group (control group). The intervention for both group will be 30 minutes per session, 3 sessions per week for a total of 4 weeks. Statistical data analysis will use the SPSS 25.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used to compare between time and groups. The significant level is set at 0.05.

Eligibility criteria: Inclusion Criteria:

* age over 50 years old
* chronic stroke (onset \>6 months)
* with mini-mental state examination (MMSE) score≧24
* Montreal cognitive assessment (MoCA) score\<26 (impaired cognition)
* ability to walk independently for at least 10 meters without assistive devices or support
* ability to read and write cognitive tests

Exclusion Criteria:

* diagnosis of dementia
* unstable physical condition
* any neurological, psychiatric disorder, or diagnosed with learning disability which may affect participation in this study
* visual or auditory disturbances

Primary outcomes:
measure: Trail-making test A&B
timeFrame: 8 minutes
measure: Stroop test
timeFrame: 10 minutes
measure: Digit span test
timeFrame: 8 minutes
measure: Clock drawing test
timeFrame: 10 minutes
Secondary outcomes:
measure: Single walking performance- speed (cm/s)
timeFrame: 3 minutes
measure: Single walking performance-step length (cm)
timeFrame: 3 minutes
measure: Single walking performance-step time (s)
timeFrame: 3 minutes
measure: Single walking performance-cadence (steps/min)
timeFrame: 3 minutes
measure: Cognitive dual task walking performance-speed (cm/s)
timeFrame: 3 minutes
measure: Cognitive dual task walking performance-step length (cm)
timeFrame: 3 minutes
measure: Cognitive dual task walking performance-step time (s)
timeFrame: 3 minutes
measure: Cognitive dual task walking performance-cadence (steps/min)
timeFrame: 3 minutes
measure: Cognitive dual task walking performance-dual task cost (%)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
state: Beitou District
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Ray-Yau Wang, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: National Yang Ming Chiao Tung University
name: Yun-Hsien Liu
role: STUDY_CHAIR
References: