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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06196411
Other study ID # HelinA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 24, 2023
Est. completion date March 18, 2024

Study information

Verified date December 2023
Source Yeditepe University
Contact Helin Arkun
Phone 0905333898504
Email helinarkun@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the randomized controlled study is to investigate the effects of task-oriented training on motor and cognitive functions combined with Bobath training in patients with stroke.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 18, 2024
Est. primary completion date February 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Volunteering to participate in the study 2. Be in the age range of 18-80 years 3. Clinical diagnosis of hemiplegia following stroke 4. Time since stroke between 2 and 8 weeks 5. Having stable vital signs 6. A score between 18-23 on the Mini Mental State Examination (MMSE) Exclusion Criteria: 1. Having global aphasia and/or severe apraxia 2. Diagnosis of dementia or Alzheimer's prior to stroke 3. Participants who discontinued treatment 4. Receiving rehabilitation service before

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Task-oriented 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 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.

Locations

Country Name City State
Turkey Eksen Saglik Inpatient Physical Therapy and Rehabilitation Center Istanbul Atasehir

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mini Mental State Examination (MMSE) The Mini Mental State Examination will be used for evaluating cognitive functions. 8 weeks
Primary Dynamic Loewenstein Occupational Therapy Cognitive Assessment- Geriatric Version (DLOTCA-G) 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
Primary Functional Independence Measure (FIM) FIM will be used to assess and rate motor and cognitive functional status in patients with stroke. 8 weeks
Primary Barthel Index (BI) BI will be used to assess motor functions. 8 weeks
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