- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06196411
Effects of Task Oriented Training in Patients With Stroke
Effects of Task Oriented Training on Cognitive and Motor Functions in Patients With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who meet the criteria will be informed about the study and volunteers will be included. When initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).
All volunteers will recieve Bobath training program with the duration of 8 weeks. Additionally, task oriented training will be applied in SG, 5 days a week for 8 weeks.
All patients will be assessed in terms of motor functions and orientation, awareness, spatial perception, visuomotor construction, visual perception, praxis and thinking operations domains of cognitive funtions at the baseline and at the end of the study. Data will be collected from all the patients at baseline and at the end of the study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ataşehir
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Istanbul, Ataşehir, Turkey, 34746
- Eksen Sağlık Inpatient Physical Therapy and Rehabilitation Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Be in the age range of 18-80 years
- Clinical diagnosis of hemiplegia following stroke
- Time since stroke between 2 and 8 weeks
- Having stable vital signs
- A score between 18-23 on the Mini Mental State Examination (MMSE)
Exclusion Criteria:
- Having global aphasia and/or severe apraxia
- Diagnosis of dementia or Alzheimer's prior to stroke
- Participants who discontinued treatment
- Receiving rehabilitation service before
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Task-oriented Training Bobath Training
|
Task-oriented training will be applied to study group 5 days a week, for a total of 6 weeks, in addition to Bobath training.
Task-oriented training will consist of performing the lying, sitting, standing and walking exercises by performing tasks for specific goals.
Exercises will be perform by accomplishing tasks such as touching the ball with the upper or lower extremities, reaching for the ball, crossing various tracks to move blocks from one place to another, walking through obstacles or climbing stairs.
Bobath Concept includes sensory, perceptual and adaptive exercises aimed at improving function through mobilisation, weight-bearing, practicing more normal movement patterns and performing more efficient, less effortful tasks.
|
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Active Comparator: Control Group
Bobath Training
|
Bobath Concept includes sensory, perceptual and adaptive exercises aimed at improving function through mobilisation, weight-bearing, practicing more normal movement patterns and performing more efficient, less effortful tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini Mental State Examination (MMSE)
Time Frame: 8 weeks
|
The Mini Mental State Examination will be used for evaluating cognitive functions.
|
8 weeks
|
|
Dynamic Loewenstein Occupational Therapy Cognitive Assessment- Geriatric Version (DLOTCA-G)
Time Frame: 8 weeks
|
DLOTCA-G is a battery test with a test booklet and test kits including 28 items in seven cognitive domains which are orientation, awareness, spatial perception, visuomotor construction, visual perception, praxis and thinking operations.
|
8 weeks
|
|
Functional Independence Measure (FIM)
Time Frame: 8 weeks
|
FIM will be used to assess and rate motor and cognitive functional status in patients with stroke.
|
8 weeks
|
|
Barthel Index (BI)
Time Frame: 8 weeks
|
BI will be used to assess motor functions.
|
8 weeks
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HelinA
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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