Effects Of Task-Oriented Training In Individuals With Stroke

Stroke Clinical Trial

Official title:

Effects Of Task-Oriented Training on Balance,Walking,Functional Mobility,Activities Of Daily Living and Quality Of Life In Individuals With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671211
• Other study ID #: MOzkeskin747
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: February 2023
• Source: Ege University
• Contact: Mehmet OZKESKIN, PhD
• Phone: +905056631833
• Email: mehmet.ozkeskin99[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 10, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Task-Oriented Training
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.
• Conventional Therapy
Conventional therapy will be consisted of balance,upper and lower extremity strengthening exercises.

Locations

Country	Name	City	State
Turkey	Bornova Türkan Ozilhan State Hospital Physical Therapy Unit	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	six weeks
Primary	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.	siz weeks
Primary	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.	siz weeks
Primary	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.	six weeks
Secondary	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.	six weeks
Secondary	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 .	six weeks
Secondary	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.	six weeks