The Effect of Dual Tasks on ADL in Stroke

NCT05592249 | Completed

• 1 other identifier: 10.2022
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Dual Task; Activity of Daily Living

Keywords

Activity; Hemiplegia; Cognitive

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 weeks

Secondary Outcomes (5)

• 10 Meter Walk Test

  6 weeks

• Timed Up and Go Test

  6 weeks

• Berg Balance Scale

  6 weeks

• Motor Activity Log - 28

  6 weeks

• Montreal Cognitive Assessment Test

  6 weeks

Study Arms (2)

Motor - Cognitive

EXPERIMENTAL

Motor - Cognitive group will receive motor and cognitive dual task intervention.

Other: Dual Task MC

Motor - Motor

EXPERIMENTAL

Motor - Motor group will receive motor and motor dual task intervention.

Other: Dual Task MM

Interventions

Dual Task MC OTHER

Dual Task MC group will receive 60 minutes motor - cognitive dual task intervention 5 day per week for 6 weeks in clinic.

Motor - Cognitive

Dual Task MM OTHER

Dual Task MM group will receive 60 minutes motor - motor dual task intervention 5 day per week for 6 weeks in clinic.

Motor - Motor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Motor Activity; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe Zengin Alpözgen, Asst. Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. (PhD)

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: December 26, 2022
• Primary Completion: December 20, 2023
• Study Completion: February 20, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)