- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05671211
Effects Of Task-Oriented Training In Individuals With Stroke
Effects Of Task-Oriented Training on Balance,Walking,Functional Mobility,Activities Of Daily Living and Quality Of Life In Individuals With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Bornova
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Izmir, Bornova, Turkey (Türkiye), 35030
- Bornova Türkan Ozilhan State Hospital Physical Therapy Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
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.
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Conventional therapy will be consisted of balance,upper and lower extremity strengthening exercises.
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Experimental: Task-Oriented Training Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale(BBS)
Time Frame: six weeks
|
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.
|
six weeks
|
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10 Meter Walking Test(10MWT)
Time Frame: siz weeks
|
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.
|
siz weeks
|
|
Timed Up And Go Test (TUG)
Time Frame: siz weeks
|
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.
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siz weeks
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Stroke-Specific Quality of Life Scale(SS-QOL)
Time Frame: six weeks
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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. |
six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5 Times Sit to Stand Test(5XSST)
Time Frame: six weeks
|
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.
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six weeks
|
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Functional Ambulation Classification (FAC)
Time Frame: six weeks
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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 .
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six weeks
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Functional Independence Scale (FIM)
Time Frame: six weeks
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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.
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six weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ALI E. MUTLU, mD, Bornova Ozilhan State Hospital Physical Therapy unit
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOzkeskin747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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