NCT05671211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

January 1, 2023

Last Update Submit

November 18, 2025

Conditions

Keywords

StrokeTas-Oriented TrainingBalanceWalkingMobilityActivities of Daily LivingQuality of Life

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • 5 Times Sit to Stand Test(5XSST)

    six weeks

  • Functional Ambulation Classification (FAC)

    six weeks

  • Functional Independence Scale (FIM)

    six weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Other: Conventional Therapy

Task-Oriented Training Group

EXPERIMENTAL

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.

Other: Task-Oriented Training

Interventions

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.

Task-Oriented Training Group

Conventional therapy will be consisted of balance,upper and lower extremity strengthening exercises.

Control Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bornova Türkan Ozilhan State Hospital Physical Therapy Unit

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • ALI E. MUTLU, mD

    Bornova Ozilhan State Hospital Physical Therapy unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 4, 2023

Study Start

January 10, 2023

Primary Completion

September 10, 2023

Study Completion

December 10, 2023

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations