StrokestrokeNCT06476431
Effects of a Cognitive Gait Dual Task With Smartglasses in Stroke Patients
A study testing dual task and non dual task in people with Stroke, run by Sahmyook University at 1 site in South Korea.
Trial summary
The aim of this study is to find out to determine changes in gait, dual-task interference, cognition, and fall scores during a cognitive walking dual task on a treadmill while wearing augmented reality-based smartglasses in stroke patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- dual task and non dual task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2024to 1 Sep 2024
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants have hemiplegia from a stroke
- Able to walk 10 meters independently without assistive devices
- Stable health to participate in the study protocol and interventions
Who cannot join
- Have comorbidities or disabilities other than stroke that may interfere with gait training
- Have an uncontrolled medical condition for which exercise is contraindicated.
- Have a neurological or orthopedic condition that may interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Cognitive Gait Dual Task With Smartglasses on Walking Ability, Dual Task Interference, Cognition, and Falls in Stroke Patients
The aim of this study is to find out to determine changes in gait, dual-task interference, cognition, and fall scores during a cognitive walking dual task on a treadmill while wearing augmented reality-based smartglasses in stroke patients.
Before the experiment, the investigators measure the subjects general characteristics, gait, cognition, dual-task interference, and fall risk. This will be done 3 times a week for 30 minutes for 4 weeks.
Read more
Group 1 will perform a cognitive task with smart glasses and a gait task on a treadmill at the same time. The training will consist of 10 minutes of treadmill walking without incline, followed by 5 minutes of rest, followed by 10 minutes of treadmill walking with incline, followed by 5 minutes of rest.
Group 2 will perform only treadmill walking without the cognitive task. Same as the experimental group: 10 minutes without treadmill incline, followed by 5 minutes rest, followed by 10 minutes treadmill incline, followed by 5 minutes rest.
At the end of the 4-week training program, the investigators will measure walking ability, cognitive performance, dual-task interference, and fall risk as assessed before the experiment.
- Conditions
- Stroke
- Being tested
- dual task, non dual task
- Keywords
- stroke, cognitive training, gait, cognition, fall
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual taskOther
The intervention program will be a program created by the researcher based on the iPad application Brainilis The tasks (logic, memory, math, and concentration) will be performed using a Type-C cable connected to the smartglasses, and the difficulty level will be adjusted according to the individual's cognitive ability. The experimental group will perform cognitive tasks with the smartglasses while simultaneously performing a walking task on a treadmill. This will be done three times a week for 30 minutes for four weeks. The subjects will not be able to touch the answers, so they will tell the therapist what they think is the correct answer and the therapist will touch the iPad to move on to the next step. The investigators will start with 10 minutes on the treadmill without incline, followed by a 5 minute break, then 10 minutes on the treadmill with incline, followed by a 5 minute break. It will run for 30 minutes, 3 times a week for 4 weeks.
non dual taskOther
No cognitive task, just treadmill walking. Same as the experimental group 1: 10 minutes without treadmill incline, followed by a 5 minute rest period, followed by 10 minutes on the treadmill with incline, followed by a 5 minute rest period. It will run for 30 minutes, 3 times a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| experimental Group 1 | Active comparator | The experimental group 1 performs a dual cognitive task on a treadmill. Receives: Other: dual task |
| experimental Group 2 | Active comparator | The experimental group 2 performs a non-dual task on a treadmill. Receives: Other: non dual task |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk test
The 6-minute walk test is a method for assessing functional performance and walking endurance in stroke patients. A straight line of 30 meters is drawn on the floor for the subject to recognize, and cones are placed at each end. During the test, the patient is asked to walk as much distance as possible as quickly as possible while walking to and from the 30-meter section, but the walking speed and rest periods are self-regulated according to the patient's ability. After starting on cue, to eliminate motivational errors during the walk, the therapist speaks only to the subjects about the remaining time and instructions, and asks them to sit in a chair after the end of the walk. The therapist records the distance walked and the number and duration of breaks during the 6-minute walk.
Measured: From enrollment to the end of treatment at 4 weeks
Dual task Interference
The 10-meter walk test will be calculated by substituting 100-7-7-7... into the formula. The single task gait speed will be calculated by measuring the gait time, finding the speed, and substituting it into the formula while walking a distance of 10 meters. The dual task gait speed will be calculated by measuring the gait time, finding the speed, and substituting it into the formula while walking a distance of 10 meters and having the therapist calculate 100-7-7 next to participants.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (5)
Trail Making Test type A/B
It assesses working memory, visual processing, visuospatial skills, selective and divided attention, processing speed, and psychomotor coordination. Pick up a pencil and draw a line, starting at one, moving to two, three, and so on. Start timing as soon as participants are told to start. Stop timing when the trail is complete, or when participants reach the maximum time of 2 minutes 30 seconds for Type A and 5 minutes for Type B. This test is scored on the total number of seconds required to complete the connection correctly. The examiner will point out and correct mistakes as they occur, and the effect of mistakes is to increase the time required to complete the test.
Measured: From enrollment to the end of treatment at 4 weeks
10m walk test
For the 10-meter walk test, mark a 14-meter straight line and make marking lines 2 meters inward from both ends of the straight line. The 2 meters at the beginning and end are set as the distance for acceleration and deceleration, and the walking time for the middle 10 meters of the walking distance is measured with a second watch to measure the walking time, find the speed, and use it as a measurement variable for functional walking.
Measured: From enrollment to the end of treatment at 4 weeks
Digit Span
The recall test requires the subject to listen to a series of numbers called out and immediately repeat them in the order in which they were heard. The first trial starts with three numbers, with one more number added at each stage, until the seventh stage requires the subject to recall a total of nine numbers. Scoring is based on the number of digits in the number of steps that the test subject performed correctly. The backward recall test is administered and scored in the same way as the straight recall test, with the test taker hearing a series of numbers similar to those presented in the straight recall test and then retelling the numbers in reverse order.
Measured: From enrollment to the end of treatment at 4 weeks
Korea version of Falls Efficacy Scale-International
The investigators developed the Korean version of the KFES-I as a subjective assessment questionnaire to predict the risk of falling among the elderly in Korea using the 16 items of the FES-I as an efficient tool to assess and measure fear of falling. The KFES-I consists of 16 items and is scored from 1 to 4 points.
Measured: From enrollment to the end of treatment at 4 weeks
Timed Up and Go test
Measure the time it takes to get up from a seated position in a chair with 46 cm high armrests, walk 3 meters to and from the chair, return, and sit down again. Allow people to use their usual shoes and walking aids during the test.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
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
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476431
- Sponsor's protocol ID
- SYU 2024-05-016-004
- Acronym
- stroke
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cognitive Gait Dual Task With Smartglasses on Walking Ability, Dual Task Interference, Cognition, and Falls in Stroke Patients
- ClinicalTrials.gov ID
- NCT06476431
- Acronym / sponsor ID
- stroke / SYU 2024-05-016-004
- Conditions
- Stroke
- Keywords
- stroke, cognitive training, gait, cognition, fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 26 Jun 2024 (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.
The aim of this study is to find out to determine changes in gait, dual-task interference, cognition, and fall scores during a cognitive walking dual task on a treadmill while wearing augmented reality-based smartglasses in stroke patients.
Before the experiment, the investigators measure the subjects general characteristics, gait, cognition, dual-task interference, and fall risk. This will be done 3 times a week for 30 minutes for 4 weeks.
Group 1 will perform a cognitive task with smart glasses and a gait task on a treadmill at the same time. The training will consist of 10 minutes of treadmill walking without incline, followed by 5 minutes of rest, followed by 10 minutes of treadmill walking with incline, followed by 5 minutes of rest.
Group 2 will perform only treadmill walking without the cognitive task. Same as the experimental group: 10 minutes without treadmill incline, followed by 5 minutes rest, followed by 10 minutes treadmill incline, followed by 5 minutes rest.
At the end of the 4-week training program, the investigators will measure walking ability, cognitive performance, dual-task interference, and fall risk as assessed before the experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental Group 1 | Active comparator | Other: dual taskThe experimental group 1 performs a dual cognitive task on a treadmill. |
| experimental Group 2 | Active comparator | Other: non dual taskThe experimental group 2 performs a non-dual task on a treadmill. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants have hemiplegia from a stroke
- Able to walk 10 meters independently without assistive devices
- Stable health to participate in the study protocol and interventions
Key exclusion criteria (3 listed)
- Have comorbidities or disabilities other than stroke that may interfere with gait training
- Have an uncontrolled medical condition for which exercise is contraindicated.
- Have a neurological or orthopedic condition that may interfere with the study
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 |
|---|---|---|
| dual taskThe intervention program will be a program created by the researcher based on the iPad application Brainilis The tasks (logic, memory, math, and concentration) will be performed using a Type-C cable connected to the smartglasses, and the difficulty level will be adjusted according to the individual's cognitive ability. The experimental group will perform cognitive tasks with the smartglasses while simultaneously performing a walking task on a treadmill. This will be done three times a week for 30 minutes for four weeks. The subjects will not be able to touch the answers, so they will tell the therapist what they think is the correct answer and the therapist will touch the iPad to move on to the next step. The investigators will start with 10 minutes on the treadmill without incline, followed by a 5 minute break, then 10 minutes on the treadmill with incline, followed by a 5 minute break. It will run for 30 minutes, 3 times a week for 4 weeks. | Other | experimental Group 1 |
| non dual taskNo cognitive task, just treadmill walking. Same as the experimental group 1: 10 minutes without treadmill incline, followed by a 5 minute rest period, followed by 10 minutes on the treadmill with incline, followed by a 5 minute rest period. It will run for 30 minutes, 3 times a week for 4 weeks. | Other | experimental Group 2 |
Primary outcome
6 minutes walk test
Time frame: From enrollment to the end of treatment at 4 weeks
The 6-minute walk test is a method for assessing functional performance and walking endurance in stroke patients. A straight line of 30 meters is drawn on the floor for the subject to recognize, and cones are placed at each end. During the test, the patient is asked to walk as much distance as possible as quickly as possible while walking to and from the 30-meter section, but the walking speed and rest periods are self-regulated according to the patient's ability. After starting on cue, to eliminate motivational errors during the walk, the therapist speaks only to the subjects about the remaining time and instructions, and asks them to sit in a chair after the end of the walk. The therapist records the distance walked and the number and duration of breaks during the 6-minute walk.
Dual task Interference
Time frame: From enrollment to the end of treatment at 4 weeks
The 10-meter walk test will be calculated by substituting 100-7-7-7... into the formula. The single task gait speed will be calculated by measuring the gait time, finding the speed, and substituting it into the formula while walking a distance of 10 meters. The dual task gait speed will be calculated by measuring the gait time, finding the speed, and substituting it into the formula while walking a distance of 10 meters and having the therapist calculate 100-7-7 next to participants.
5 secondary outcomes
Trail Making Test type A/B
Time frame: From enrollment to the end of treatment at 4 weeks
10m walk test
Time frame: From enrollment to the end of treatment at 4 weeks
Digit Span
Time frame: From enrollment to the end of treatment at 4 weeks
Korea version of Falls Efficacy Scale-International
Time frame: From enrollment to the end of treatment at 4 weeks
Timed Up and Go test
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No. only IPD used in the results publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual task and non dual task in people with Stroke, run by Sahmyook University at 1 site in South Korea.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. 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 South Korea. 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?
Results are not available in the source record.
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?
6 minutes walk test (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 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 25 Jul 2024.