StrokeNCT06196411
Effects of Task Oriented Training in Patients With Stroke
A study testing Task-oriented Training and Bobath Training in people with Stroke, run by Yeditepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Task-oriented Training and Bobath Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2023to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Having global aphasia and/or severe apraxia
- Diagnosis of dementia or Alzheimer's prior to stroke
- Participants who discontinued treatment
- Receiving rehabilitation service before
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eksen Sağlık Inpatient Physical Therapy and Rehabilitation Center
Istanbul, Ataşehir, 34746
About this study
Official title: Effects of Task Oriented Training on Cognitive and Motor Functions in Patients With Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Task-oriented Training, Bobath Training
- Keywords
- Stroke, Task-oriented training, Bobath training, Motor functions, Cognitive functions
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Task-oriented Training Bobath Training Receives: Behavioral: Task-oriented Training; Behavioral: Bobath Training |
| Control Group | Active comparator | Bobath Training Receives: Behavioral: Bobath Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination (MMSE)
The Mini Mental State Examination will be used for evaluating cognitive functions.
Measured: 8 weeks
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.
Measured: 8 weeks
Functional Independence Measure (FIM)
FIM will be used to assess and rate motor and cognitive functional status in patients with stroke.
Measured: 8 weeks
Barthel Index (BI)
BI will be used to assess motor functions.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start24 Dec 2023
- Primary completion19 Feb 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196411
- Sponsor's protocol ID
- HelinA
- Status last verified
- Jul 2024
- First submitted
- 25 Dec 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task Oriented Training on Cognitive and Motor Functions in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06196411
- Acronym / sponsor ID
- HelinA
- Conditions
- Stroke
- Keywords
- Stroke, Task-oriented training, Bobath training, Motor functions, Cognitive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Task-oriented Training, Behavioral: Bobath TrainingTask-oriented Training Bobath Training |
| Control Group | Active comparator | Behavioral: Bobath TrainingBobath Training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Having global aphasia and/or severe apraxia
- Diagnosis of dementia or Alzheimer's prior to stroke
- Participants who discontinued treatment
- Receiving rehabilitation service before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-oriented TrainingTask-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. | Behavioural | Study Group |
| Bobath TrainingBobath 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. | Behavioural | Control Group, Study Group |
Primary outcome
Mini Mental State Examination (MMSE)
Time frame: 8 weeks
The Mini Mental State Examination will be used for evaluating cognitive functions.
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.
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.
Barthel Index (BI)
Time frame: 8 weeks
BI will be used to assess motor functions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
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Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented Training and Bobath Training in people with Stroke, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Mental State Examination (MMSE) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.