StrokeNCT05592249
The Effect of Dual Tasks on ADL in Stroke
A study testing Dual Task MC and Dual Task MM in people with Stroke and Dual Task, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of different dual-task practices on activities of daily living in stroke patients. The sample size was calculated as 18 people for each group and 36 people in total, with a 20% drop out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Dual Task, Activity of Daily Living
- What is being tested?
- Dual Task MC and Dual Task MM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2022to 20 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed with stroke by a specialist physician
- Modified Rankin Score ≤ 3 with moderate or mild disability
- To score 21 and above on the Montreal Cognitive Assessment Test
- Be over 18 years old
- Volunteering to participate in the study
Who cannot join
- Presence of additional neurological disease
- Having orthopedic problems that may prevent walking
- Presence of apraxia
- The patient has a hearing loss that cannot understand the commands given
- To have a score below 30 on the Beck Depression Scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Dual Task Practices on Activities of Daily Living in Stroke Individuals
The aim of this study is to investigate the effectiveness of different dual-task practices on activities of daily living in stroke patients. The sample size was calculated as 18 people for each group and 36 people in total, with a 20% drop out. MC (Motor - Cognitive) group will receive 60 minutes motor - cognitive dual task intervention 5 day per week for 6 weeks in clinic. MM (Motor - Motor) group will receive 60 minutes motor - motor dual task intervention 5 day per week for 6 weeks in clinic. As the primary outcomes in the study; Modified Barthel Index will be used to evaluate basic activities of daily living, Nottingham Extended Activities of Daily Living Index designed specifically for stroke to evaluate instrumental activities of daily living, and Stroke Impact Scale 3.0 to evaluate participation in activities of daily living. As secondary outcomes; 10 Meter Walk Test will be used for functional mobility assessment, Timed Up and Go Test and Berg Balance Scale will be used for balance assessment, Motor Activity Log-28 will be used to assess upper extremity functions, and Montreal Cognitive Assessment Test will be used for cognitive status assessment.
Read the detailed description
Postural control is lost due to decrease in unilateral muscle strength and joint range of motion, and increase in muscle tone in stroke individuals, and accordingly, deterioration in balance and coordination between the two sides of the body is observed. Spasticity, abnormal movement patterns, and loss of motor control are observed in patients, and ambulation limitations occur in patients. In addition, approximately two-thirds of stroke patients have impairments in cognitive skills, which are necessary for the realization of motor skills. Depending on the executive dysfunction, problems also arise in the planning, sequencing, and coordination of actions. Stroke patients have difficulty in doing many activities that they encounter in their daily lives, such as walking and climbing stairs, and as a result, their quality of life and participation in daily life activities are negatively affected. For this reason, approaches aimed at regulating not only muscle tone and strength, but also approaches to ensure participation in daily life activities and increase functionality should be preferred in the rehabilitation process of stroke patients.
Considering the traditional approaches applied in stroke rehabilitation, it is seen that balance and gait training are frequently given to patients. However, in daily life, it may be necessary to use cognitive skills as well as motor activities simultaneously or to perform two motor skills at the same time. Patients have difficulty in performing two tasks at the same time, such as carrying a bag while climbing stairs, calculating while walking, and reading a newspaper while on an exercise bike. In order to increase the participation of stroke patients in daily life, the dual-task approach should be included in the treatment strategies.
Dual task applications are the ability to perform two tasks at the same time, which have different goals and can be evaluated separately, and is a motor learning-based approach. One of the tasks may be a motor task and the other may be a cognitive task, or both may be a motor task. Studies have concluded that dual-task training has positive effects on gait parameters, balance, and cognition, and it has been reported that it is a current approach that can be used in the treatment of stroke patients. However, there is no study comparing the participation of dual tasks, such as one cognitive and one motor task or two motor tasks, in activities of daily living in stroke patients.
When activities of daily living are examined, most of the motor activities are accompanied by actions that include cognitive processes such as attention, memory, problem solving, and concentration. For this reason, in this study, it is assumed that different dual-task approaches to be applied in the rehabilitation of stroke patients will give different results in the participation of individuals in daily life activities and that the application of motor and cognitive tasks together will be more effective than the application of two motor tasks together. In the light of all these, the aim of this study is to investigate the effectiveness of different dual-task practices on activities of daily living in stroke patients.
The hypothesis of this study is;
H0: In the dual task approach applied to individuals with stroke, the application of motor and cognitive tasks together is not more effective in daily living activities compared to the two motor tasks.
H1: In the dual task approach applied to individuals with stroke, the application of motor and cognitive tasks together is more effective in daily living activities compared to the two motor tasks.
- Conditions
- Stroke, Dual Task, Activity of Daily Living
- Being tested
- Dual Task MC, Dual Task MM
- Keywords
- Activity, Hemiplegia, Cognitive
- Medical subject headings
- Stroke, Motor Activity, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task MCOther
Dual Task MC group will receive 60 minutes motor - cognitive dual task intervention 5 day per week for 6 weeks in clinic.
Dual Task MMOther
Dual Task MM group will receive 60 minutes motor - motor dual task intervention 5 day per week for 6 weeks in clinic.
| Study group | Role | What they receive |
|---|---|---|
| Motor - Cognitive | Experimental | Motor - Cognitive group will receive motor and cognitive dual task intervention. Receives: Other: Dual Task MC |
| Motor - Motor | Experimental | Motor - Motor group will receive motor and motor dual task intervention. Receives: Other: Dual Task MM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Barthel Index
The Modified Barthel Index (MBI) is a scale created to evaluate functional independence. The scale evaluates the functional independence level of the person in 10 activities, including transfer, ambulation, stairs, feeding, dressing, personal care, bathroom, toilet use, and urine and stool continence. Each question is answered in 5 different levels. Level 1 means "The individual is inadequate to do the activity." while Level 5 means "Completely independent.". The score that the patient can get is between 0-100. The higher the score, the higher the person's level of functional independence.
Measured: 6 weeks
Nottingham Extended Activities of Daily Living Index
The Nottingham Extended Activities of Daily Living Index is a scale designed specifically for stroke and evaluated by self-report. This scale, which aims to measure the quality of daily life of individuals in instrumental activities based on performance, consists of 4 subgroups as movement, kitchen, housework and leisure activities and a total of 22 items. Each question evaluates the difficulty of the activity on a 4-point Likert scale. 0 points means "I can't do it at all." 3 points means "I do it easily by myself.". The maximum score that can be obtained from the scale is 66. An increase in the score indicates independence in the instrumental activities of daily living.
Measured: 6 weeks
Stroke Impact Scale 3.0
The Stroke Impact Scale (SIS) 3.0 aims to evaluate the quality of life of patients after stroke, consists of 8 subsections and a total of 59 questions. It evaluates muscle strength, hand functions, activities of daily living, mobility, communication skills, mood, memory and participation of patients after stroke. Each question is scored by evaluating on a 5-point Likert-type scale. 1 point means not being able to perform the function asked at all, while 5 points means not having any difficulties. In addition to 8 sub-sections, there is a visual analog scale that is scored between 0-100 at the end of the scale and the perception of recovery after stroke is evaluated. A score of 0 on this scale is "No improvement at all." A score of 100 means "Complete recovery". The maximum score that can be obtained is 395, and the minimum score is 59. An increase in the total score in SIS indicates the independence of the patient in activities of daily living while a decrease indicates dependence.
Measured: 6 weeks
Secondary outcomes (5)
10 Meter Walk Test
The 10 Meter Walk Test (10 MWT) is a test that evaluates a person's walking performance. For the application, a total distance of 14 meters is determined with the start and end points of which the first and last 2 meters are marked. The patients are asked to walk the determined distance at their normal walking speed, and as soon as the 2 meter line is reached, the measurement is started with the stopwatch, and the stopwatch is stopped at the 12 meter line. The time is recorded in seconds. To minimize effects such as habituation and fatigue, the test is repeated twice and the average second is recorded. In stroke patients, if the gait speed is below 0.4 m/s, it is interpreted as indoor ambulation, between 0.4-0.8 m/s as limited community ambulation, and above 0.8 m/s as full community ambulation.
Measured: 6 weeks
Timed Up and Go Test
The Timed Up and Go Test (TUG) is a general physical performance test used to evaluate a person's balance and locomotor performance. The assessment ends with the person getting up from the chair, walking 3 meters, turning around, and returning to sit on the chair again. The person is told to walk at a normal walking pace. The time is recorded in seconds. Completing the test in less than 10 seconds is interpreted as being completely independent, completing the test between 10-20 seconds is considered independent for main transfers, and completing the test over 30 seconds is interpreted as needing help in most activities.
Measured: 6 weeks
Berg Balance Scale
Berg Balance Scale (BBS) is a 14-item scale that measures the ability of individuals to maintain their balance during functional activities. Each task in the scale is scored between 0-4. 0 point means "Cannot perform independently." 4 point means "Completes the activity independently.". The maximum score that can be obtained from the scale is 56. A score of 0-20 indicates balance disorder and high fall risk, 21-40 points indicates the presence of an acceptable balance and moderate fall risk, 41-56 points indicates the presence of good balance and low fall risk.
Measured: 6 weeks
Motor Activity Log - 28
The Motor Activity Log - 28 (MAL - 28) consists of two scales questioning how often the patient uses the upper extremity on the affected side during various activities and, if so, with what quality. The person answers the questions on the scale by scoring between 0 and 5. 0 point means "I don't use my affected arm at all." 5 point means "I use my affected arm in the same way as before the stroke.". If the patient has difficulty in scoring, he can also use half points such as 2.5, 3.5. If the patient chooses 0 points during scoring, the reason is questioned and one of the 5 reasons for not using is noted. The maximum score that can be obtained from the scale is 280. The higher the score, the higher the frequency and quality of use of the arm.
Measured: 6 weeks
Montreal Cognitive Assessment Test
MOCA is an assessment scale used to evaluate cognitive impairment. It includes items evaluating visuospatial skills, executive functions, naming, memory, attention, language, abstract thinking, delayed recall, and orientation. The maximum score that can be obtained from the scale is 30, and the minimum score is 0. Scores of 21 and above are considered normal. A decrease in the score indicates cognitive impairment in the patient.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start26 Dec 2022
- Primary completion20 Dec 2023
- Study completion20 Feb 2024
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.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Zengin Alpözgen, Asst. Prof., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592249
- Sponsor's protocol ID
- 10.2022
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2022
- Last updated
- 21 Feb 2024
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Dual Task Practices on Activities of Daily Living in Stroke Individuals
- ClinicalTrials.gov ID
- NCT05592249
- Acronym / sponsor ID
- 10.2022
- Conditions
- Stroke, Dual Task, Activity of Daily Living
- Keywords
- Activity, Hemiplegia, Cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 24 Oct 2022 (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 investigate the effectiveness of different dual-task practices on activities of daily living in stroke patients. The sample size was calculated as 18 people for each group and 36 people in total, with a 20% drop out. MC (Motor - Cognitive) group will receive 60 minutes motor - cognitive dual task intervention 5 day per week for 6 weeks in clinic. MM (Motor - Motor) group will receive 60 minutes motor - motor dual task intervention 5 day per week for 6 weeks in clinic. As the primary outcomes in the study; Modified Barthel Index will be used to evaluate basic activities of daily living, Nottingham Extended Activities of Daily Living Index designed specifically for stroke to evaluate instrumental activities of daily living, and Stroke Impact Scale 3.0 to evaluate participation in activities of daily living. As secondary outcomes; 10 Meter Walk Test will be used for functional mobility assessment, Timed Up and Go Test and Berg Balance Scale will be used for balance assessment, Motor Activity Log-28 will be used to assess upper extremity functions, and Montreal Cognitive Assessment Test will be used for cognitive status assessment.
Detailed description
Postural control is lost due to decrease in unilateral muscle strength and joint range of motion, and increase in muscle tone in stroke individuals, and accordingly, deterioration in balance and coordination between the two sides of the body is observed. Spasticity, abnormal movement patterns, and loss of motor control are observed in patients, and ambulation limitations occur in patients. In addition, approximately two-thirds of stroke patients have impairments in cognitive skills, which are necessary for the realization of motor skills. Depending on the executive dysfunction, problems also arise in the planning, sequencing, and coordination of actions. Stroke patients have difficulty in doing many activities that they encounter in their daily lives, such as walking and climbing stairs, and as a result, their quality of life and participation in daily life activities are negatively affected. For this reason, approaches aimed at regulating not only muscle tone and strength, but also approaches to ensure participation in daily life activities and increase functionality should be preferred in the rehabilitation process of stroke patients.
Considering the traditional approaches applied in stroke rehabilitation, it is seen that balance and gait training are frequently given to patients. However, in daily life, it may be necessary to use cognitive skills as well as motor activities simultaneously or to perform two motor skills at the same time. Patients have difficulty in performing two tasks at the same time, such as carrying a bag while climbing stairs, calculating while walking, and reading a newspaper while on an exercise bike. In order to increase the participation of stroke patients in daily life, the dual-task approach should be included in the treatment strategies.
Dual task applications are the ability to perform two tasks at the same time, which have different goals and can be evaluated separately, and is a motor learning-based approach. One of the tasks may be a motor task and the other may be a cognitive task, or both may be a motor task. Studies have concluded that dual-task training has positive effects on gait parameters, balance, and cognition, and it has been reported that it is a current approach that can be used in the treatment of stroke patients. However, there is no study comparing the participation of dual tasks, such as one cognitive and one motor task or two motor tasks, in activities of daily living in stroke patients.
When activities of daily living are examined, most of the motor activities are accompanied by actions that include cognitive processes such as attention, memory, problem solving, and concentration. For this reason, in this study, it is assumed that different dual-task approaches to be applied in the rehabilitation of stroke patients will give different results in the participation of individuals in daily life activities and that the application of motor and cognitive tasks together will be more effective than the application of two motor tasks together. In the light of all these, the aim of this study is to investigate the effectiveness of different dual-task practices on activities of daily living in stroke patients.
The hypothesis of this study is;
H0: In the dual task approach applied to individuals with stroke, the application of motor and cognitive tasks together is not more effective in daily living activities compared to the two motor tasks.
H1: In the dual task approach applied to individuals with stroke, the application of motor and cognitive tasks together is more effective in daily living activities compared to the two motor tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor - Cognitive | Experimental | Other: Dual Task MCMotor - Cognitive group will receive motor and cognitive dual task intervention. |
| Motor - Motor | Experimental | Other: Dual Task MMMotor - Motor group will receive motor and motor dual task intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be diagnosed with stroke by a specialist physician
- Modified Rankin Score ≤ 3 with moderate or mild disability
- To score 21 and above on the Montreal Cognitive Assessment Test
- Be over 18 years old
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- Presence of additional neurological disease
- Having orthopedic problems that may prevent walking
- Presence of apraxia
- The patient has a hearing loss that cannot understand the commands given
- To have a score below 30 on the Beck Depression Scale
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 Task MCDual Task MC group will receive 60 minutes motor - cognitive dual task intervention 5 day per week for 6 weeks in clinic. | Other | Motor - Cognitive |
| Dual Task MMDual Task MM group will receive 60 minutes motor - motor dual task intervention 5 day per week for 6 weeks in clinic. | Other | Motor - Motor |
Primary outcome
Modified Barthel Index
Time frame: 6 weeks
The Modified Barthel Index (MBI) is a scale created to evaluate functional independence. The scale evaluates the functional independence level of the person in 10 activities, including transfer, ambulation, stairs, feeding, dressing, personal care, bathroom, toilet use, and urine and stool continence. Each question is answered in 5 different levels. Level 1 means "The individual is inadequate to do the activity." while Level 5 means "Completely independent.". The score that the patient can get is between 0-100. The higher the score, the higher the person's level of functional independence.
Nottingham Extended Activities of Daily Living Index
Time frame: 6 weeks
The Nottingham Extended Activities of Daily Living Index is a scale designed specifically for stroke and evaluated by self-report. This scale, which aims to measure the quality of daily life of individuals in instrumental activities based on performance, consists of 4 subgroups as movement, kitchen, housework and leisure activities and a total of 22 items. Each question evaluates the difficulty of the activity on a 4-point Likert scale. 0 points means "I can't do it at all." 3 points means "I do it easily by myself.". The maximum score that can be obtained from the scale is 66. An increase in the score indicates independence in the instrumental activities of daily living.
Stroke Impact Scale 3.0
Time frame: 6 weeks
The Stroke Impact Scale (SIS) 3.0 aims to evaluate the quality of life of patients after stroke, consists of 8 subsections and a total of 59 questions. It evaluates muscle strength, hand functions, activities of daily living, mobility, communication skills, mood, memory and participation of patients after stroke. Each question is scored by evaluating on a 5-point Likert-type scale. 1 point means not being able to perform the function asked at all, while 5 points means not having any difficulties. In addition to 8 sub-sections, there is a visual analog scale that is scored between 0-100 at the end of the scale and the perception of recovery after stroke is evaluated. A score of 0 on this scale is "No improvement at all." A score of 100 means "Complete recovery". The maximum score that can be obtained is 395, and the minimum score is 59. An increase in the total score in SIS indicates the independence of the patient in activities of daily living while a decrease indicates dependence.
5 secondary outcomes
10 Meter Walk Test
Time frame: 6 weeks
Timed Up and Go Test
Time frame: 6 weeks
Berg Balance Scale
Time frame: 6 weeks
Motor Activity Log - 28
Time frame: 6 weeks
Montreal Cognitive Assessment Test
Time frame: 6 weeks
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 21 Feb 2024.
- 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.
Ayşe Zengin Alpözgen, Asst. Prof. principal investigator
Istanbul University - Cerrahpasa
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 MC and Dual Task MM in people with Stroke and Dual Task, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 21 Feb 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 Turkey (Türkiye). 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?
Modified Barthel Index (time frame: 6 weeks). The study lists 3 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 21 Feb 2024.