Clinical trial NCT05592249: The Effect of Dual Tasks on ADL in Stroke
Official title: The Effect of Different Dual Task Practices on Activities of Daily Living in Stroke Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dual Task
Activity of Daily Living
Keywords: Activity
Hemiplegia
Cognitive
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Modified Barthel Index
timeFrame: 6 weeks
measure: Nottingham Extended Activities of Daily Living Index
timeFrame: 6 weeks
measure: Stroke Impact Scale 3.0
timeFrame: 6 weeks
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: 6 weeks
measure: Timed Up and Go Test
timeFrame: 6 weeks
measure: Berg Balance Scale
timeFrame: 6 weeks
measure: Motor Activity Log - 28
timeFrame: 6 weeks
measure: Montreal Cognitive Assessment Test
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayşe Zengin Alpözgen, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: