Back to resultsEffects Of Task-Oriented Training In Individuals With Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Task-Oriented Training
Conventional Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Tas-Oriented Training, Balance, Walking, Mobility, Activities of Daily Living, Quality of Life
Eligibility Criteria
Inclusion Criteria: Modified Rankin score between 0-3 Having a stroke for the first time At least 1 month has passed since the stroke Able to walk 10 M with or without assistance Having a Mini Mental Test score of 24 and above Volunteering to participate in the study Being fluent in Turkish language Exclusion Criteria: Having an additional neurological disease other than stroke Having an additional disease that prevents mobility Having a condition that prevents you from exercising Receiving an existing additional medical treatment for spasticity treatment Having a history of multiple strokes Having severe visual problems post stoke
Sites / Locations
- Bornova Türkan Ozilhan State Hospital Physical Therapy UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Task-Oriented Training Group
Arm Description
Participants in control group will receive an exercise program consisted of upper and lower extremity strengthening and balance exercises.The exercises will be started as 8-10 repetitions and one set and the number of sets will be increased according to the progression of the patient. Exercises will be applied for 6 weeks, 5 days a week, for a total of 30 sessions, each session for 1 hour.
Participants in the task-oriented training group will receive the same treatment given to the control group, with an additional 30 minutes of task-oriented training.Task-Oriented Training Program will include several everyday tasks (Getting up from the chair, walking 10 steps taking a book from the table and walking backwards to sit on the chair,Walking forward and sideways over obstacles...etc.).The exercises will be started as 12-15 repetitions and 1 set at the beginning, and the number of sets will be increased according to the progression of the patient. A total of 30 sessions will be applied, 5 days a week for 6 weeks, with a total of 1.5 hours of exercises.
Outcomes
Primary Outcome Measures
Berg Balance Scale(BBS)
BBS, evaluates daily activities including static sitting and standing balance, as well as transfers, turning, and picking up objects from the ground, in 14 items.Scoring is given as 0-4. It scores from 4 (normal performance) to 0 (not able to do the movement) according to the person's ability to do what is asked of them safely and independently. The total score is 56 points. 0-20 indicates high risk, 21-40 indicates medium risk, and 41-64 indicates low risk.
10 Meter Walking Test(10MWT)
This test calculates the unassisted walking speed of individuals at a distance of 10 meters. In this test, the person will be asked to walk at their normal pace in a pre-measured 10 meter area.
Timed Up And Go Test (TUG)
It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.
Stroke-Specific Quality of Life Scale(SS-QOL)
The Stroke-Specific Quality of Life Scale evaluates the quality of life in post-stroke individuals.
It consists of 49 items from 12 areas;energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, work/productivity. Each item is evaluated on a 5-point Likert scale. Maximum score is 245, high scores indicates good quality of life.
Secondary Outcome Measures
5 Times Sit to Stand Test(5XSST)
The 5 Repetitive Sit-Rise Test (5XSST) is a practical test that evaluates lower extremity functional strength and balance.The individual rests on a standard 43 cm chair, arms crossed over shoulders, feet on the floor.Individual will be asked to sit and stand up quickly 5 times. Duration of 5 repetitions will be recorded in seconds.Results below 15 seconds indicate good stability, while 15 seconds and above indicate impaired balance and function.
Functional Ambulation Classification (FAC)
Functional Ambulation Classification (FAC) is a common clinical gait assessment method. Walking ability is scored between 0-5 according to the amount of support needed during the training and classification is made over 6 categories.. 5 points indicate fully independent ambulation while 0 points indicate non-functional ambulation .
Functional Independence Scale (FIM)
Functional Independence Scale is used to evaluate activities of daily living.- It consists of a total of 18 items(13 physical,5 social) that include cognitive status assessment. Each item is scored between 1 and 7. 7 means that the specified item is performed completely independently, while 1 indicates the need of full assistance. The maximum score that can be obtained from the scale is 126, indicating good performance. The lowest score is 18 and shows poor performance.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05671211
Brief Title
Effects Of Task-Oriented Training In Individuals With Stroke
Official Title
Effects Of Task-Oriented Training on Balance,Walking,Functional Mobility,Activities Of Daily Living and Quality Of Life In Individuals With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effects of task-oriented training on balance,functional mobility,walking, activities of daily living and quality of life in individuals with stroke.
Detailed Description
Eligible participants will be randomized to task-oriented group or control group.Control group will receive conventional therapy generally consisted of neurophysiological approaches for 6 weeks 5 times a week for 1 hour per session.Task-oriented group will receive conventional therapy and task-oriented training for 6 weeks 5 times a week 1,5 hours per session.Each participant will be assessed before and after the 6 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Tas-Oriented Training, Balance, Walking, Mobility, Activities of Daily Living, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in control group will receive an exercise program consisted of upper and lower extremity strengthening and balance exercises.The exercises will be started as 8-10 repetitions and one set and the number of sets will be increased according to the progression of the patient. Exercises will be applied for 6 weeks, 5 days a week, for a total of 30 sessions, each session for 1 hour.
Arm Title
Task-Oriented Training Group
Arm Type
Experimental
Arm Description
Participants in the task-oriented training group will receive the same treatment given to the control group, with an additional 30 minutes of task-oriented training.Task-Oriented Training Program will include several everyday tasks (Getting up from the chair, walking 10 steps taking a book from the table and walking backwards to sit on the chair,Walking forward and sideways over obstacles...etc.).The exercises will be started as 12-15 repetitions and 1 set at the beginning, and the number of sets will be increased according to the progression of the patient. A total of 30 sessions will be applied, 5 days a week for 6 weeks, with a total of 1.5 hours of exercises.
Intervention Type
Other
Intervention Name(s)
Task-Oriented Training
Intervention Description
Participants in this group will receive 30 minutes of task-oriented training and 1 hour of conventional therapy for 6 weeks 5 times a week.
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
Conventional therapy will be consisted of balance,upper and lower extremity strengthening exercises.
Primary Outcome Measure Information:
Title
Berg Balance Scale(BBS)
Description
BBS, evaluates daily activities including static sitting and standing balance, as well as transfers, turning, and picking up objects from the ground, in 14 items.Scoring is given as 0-4. It scores from 4 (normal performance) to 0 (not able to do the movement) according to the person's ability to do what is asked of them safely and independently. The total score is 56 points. 0-20 indicates high risk, 21-40 indicates medium risk, and 41-64 indicates low risk.
Time Frame
six weeks
Title
10 Meter Walking Test(10MWT)
Description
This test calculates the unassisted walking speed of individuals at a distance of 10 meters. In this test, the person will be asked to walk at their normal pace in a pre-measured 10 meter area.
Time Frame
siz weeks
Title
Timed Up And Go Test (TUG)
Description
It is a frequently used test that evaluates functional mobility and dynamic balance. At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of the patient. With the start command, the patient gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time until the moment of sitting on the chair is recorded in seconds.Shorter duration indicates better functional mobility.
Time Frame
siz weeks
Title
Stroke-Specific Quality of Life Scale(SS-QOL)
Description
The Stroke-Specific Quality of Life Scale evaluates the quality of life in post-stroke individuals.
It consists of 49 items from 12 areas;energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, work/productivity. Each item is evaluated on a 5-point Likert scale. Maximum score is 245, high scores indicates good quality of life.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
5 Times Sit to Stand Test(5XSST)
Description
The 5 Repetitive Sit-Rise Test (5XSST) is a practical test that evaluates lower extremity functional strength and balance.The individual rests on a standard 43 cm chair, arms crossed over shoulders, feet on the floor.Individual will be asked to sit and stand up quickly 5 times. Duration of 5 repetitions will be recorded in seconds.Results below 15 seconds indicate good stability, while 15 seconds and above indicate impaired balance and function.
Time Frame
six weeks
Title
Functional Ambulation Classification (FAC)
Description
Functional Ambulation Classification (FAC) is a common clinical gait assessment method. Walking ability is scored between 0-5 according to the amount of support needed during the training and classification is made over 6 categories.. 5 points indicate fully independent ambulation while 0 points indicate non-functional ambulation .
Time Frame
six weeks
Title
Functional Independence Scale (FIM)
Description
Functional Independence Scale is used to evaluate activities of daily living.- It consists of a total of 18 items(13 physical,5 social) that include cognitive status assessment. Each item is scored between 1 and 7. 7 means that the specified item is performed completely independently, while 1 indicates the need of full assistance. The maximum score that can be obtained from the scale is 126, indicating good performance. The lowest score is 18 and shows poor performance.
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Modified Rankin score between 0-3
Having a stroke for the first time
At least 1 month has passed since the stroke
Able to walk 10 M with or without assistance
Having a Mini Mental Test score of 24 and above
Volunteering to participate in the study
Being fluent in Turkish language
Exclusion Criteria:
Having an additional neurological disease other than stroke
Having an additional disease that prevents mobility
Having a condition that prevents you from exercising
Receiving an existing additional medical treatment for spasticity treatment
Having a history of multiple strokes
Having severe visual problems post stoke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet OZKESKIN, PhD
Phone
+905056631833
Email
mehmet.ozkeskin99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
BENNU D. EZGIN, BSc
Phone
+905535070836
Email
bennuezgin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALI E. MUTLU, mD
Organizational Affiliation
Bornova Ozilhan State Hospital Physical Therapy unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bornova Türkan Ozilhan State Hospital Physical Therapy Unit
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MEHMET OZKESKIN, PhD
Phone
+905056631833
Email
mehmet.ozkeskin99@gmail.com
First Name & Middle Initial & Last Name & Degree
BENNU D. EZGIN, BSc
Phone
+905535070836
Email
bennuezgin@gmail.com
First Name & Middle Initial & Last Name & Degree
ALI E. MUTLU, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects Of Task-Oriented Training In Individuals With Stroke
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