StrokeNCT04545138
Combining Cognitive and Treadmill Training on Cognition and Walking Performance in Stroke With Cognitive Impairment
A study testing cognitive training combine treadmill training and Treadmill training in people with Stroke and Cognitive Impairment, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Cognitive Impairment
- What is being tested?
- cognitive training combine treadmill training and Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2020to 22 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combining Cognitive and Treadmill Training on Cognitive Function and Walking Performance-Exploration in Chronic Stroke Patient With Cognitive Impairment
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.
Read the 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.
- Conditions
- Stroke, Cognitive Impairment
- Being tested
- cognitive training combine treadmill training, Treadmill training
- Keywords
- Stroke, Cognitive Impairment, Cognitive and treadmill training
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive training combine treadmill trainingOther
Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight), and ensures that patients can be cognitively trained at the same time. The cognitive training tasks will be projected on the screen and the participant have to answer the task orders during treadmill training simultaneously.
Treadmill trainingOther
Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight).
| Study group | Role | What they receive |
|---|---|---|
| cognitive training during treadmill training group | Experimental | Cognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously. Receives: Other: cognitive training combine treadmill training |
| treadmill training group | Active comparator | Treadmill training as an active control. Receives: Other: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail-making test A&B
executive function (s)
Measured: 8 minutes
Stroop test
attention (number)
Measured: 10 minutes
Digit span test
memory (number)
Measured: 8 minutes
Clock drawing test
visuospatial function (score 1-10)
Measured: 10 minutes
Secondary outcomes (9)
Single walking performance- speed (cm/s)
walking speed in centimeters per second will be calculated during the single walking by using the GaitRite system
Measured: 3 minutes
Single walking performance-step length (cm)
step length in centimeters will be calculated during the single walking by using the GaitRite system
Measured: 3 minutes
Single walking performance-step time (s)
step time in seconds will be calculated during the single walking by using the GaitRite system
Measured: 3 minutes
Single walking performance-cadence (steps/min)
cadence in steps per minute will be calculated during the single walking by using the GaitRite system
Measured: 3 minutes
Cognitive dual task walking performance-speed (cm/s)
walking speed in centimeters per second will be calculated during the cognitive dual task walking by using the GaitRite system
Measured: 3 minutes
Cognitive dual task walking performance-step length (cm)
step length in centimeters will be calculated during the cognitive dual task walking by using the GaitRite system
Measured: 3 minutes
Cognitive dual task walking performance-step time (s)
step time in seconds will be calculated during the cognitive dual task walking by using the GaitRite system
Measured: 3 minutes
Cognitive dual task walking performance-cadence (steps/min)
cadence in steps per minute will be calculated during the cognitive dual task walking by using the GaitRite system
Measured: 3 minutes
Cognitive dual task walking performance-dual task cost (%)
dual task cost (%) will be calculated with the following formula: [(dual-task performance-single task performance) / single task performance] × 100%
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start10 Sep 2020
- Primary completion18 Sep 2020
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ray-Yau Wang, professor, Principal investigator, National Yang Ming Chiao Tung UniversityYun-Hsien Liu, Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545138
- Sponsor's protocol ID
- YM109069F
- Status last verified
- Jul 2020
- First submitted
- 13 Aug 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combining Cognitive and Treadmill Training on Cognitive Function and Walking Performance-Exploration in Chronic Stroke Patient With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04545138
- Acronym / sponsor ID
- YM109069F
- Conditions
- Stroke, Cognitive Impairment
- Keywords
- Stroke, Cognitive Impairment, Cognitive and treadmill training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive training during treadmill training group | Experimental | Other: cognitive training combine treadmill trainingCognitive training combine treadmill training is an intervention that can challenge participants by practicing different tasks simultaneously. |
| treadmill training group | Active comparator | Other: Treadmill trainingTreadmill training as an active control. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive training combine treadmill trainingTreadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight), and ensures that patients can be cognitively trained at the same time. The cognitive training tasks will be projected on the screen and the participant have to answer the task orders during treadmill training simultaneously. | Other | cognitive training during treadmill training group |
| Treadmill trainingTreadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight). | Other | treadmill training group |
Primary outcome
Trail-making test A&B
Time frame: 8 minutes
executive function (s)
Stroop test
Time frame: 10 minutes
attention (number)
Digit span test
Time frame: 8 minutes
memory (number)
Clock drawing test
Time frame: 10 minutes
visuospatial function (score 1-10)
9 secondary outcomes
Single walking performance- speed (cm/s)
Time frame: 3 minutes
Single walking performance-step length (cm)
Time frame: 3 minutes
Single walking performance-step time (s)
Time frame: 3 minutes
Single walking performance-cadence (steps/min)
Time frame: 3 minutes
Cognitive dual task walking performance-speed (cm/s)
Time frame: 3 minutes
Cognitive dual task walking performance-step length (cm)
Time frame: 3 minutes
Cognitive dual task walking performance-step time (s)
Time frame: 3 minutes
Cognitive dual task walking performance-cadence (steps/min)
Time frame: 3 minutes
Cognitive dual task walking performance-dual task cost (%)
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray-Yau Wang, professor principal investigator
National Yang Ming Chiao Tung University
Yun-Hsien Liu study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training combine treadmill training and Treadmill training in people with Stroke and Cognitive Impairment, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail-making test A&B (time frame: 8 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.