StrokeNCT06186661
Multicontextual Treatment Approach in Stroke
A study testing neurophysiological exercise and cognitive rehabilitation in people with Stroke and Cognitive Impairment, run by ozden erkan at 1 site in Turkey (Türkiye).
Trial summary
BACKGROUND: It is known that cognitive disorders affect the rehabilitation of stroke patients but which cognitive rehabilitation intervention should apply to stroke patients and what their effects are on their life is not clear yet. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cognitive Impairment, Quality of Life
- What is being tested?
- neurophysiological exercise and cognitive rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jul 2011to 13 Jun 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with the first time diagnosis of stroke, between 18-80 age range, a post-stroke period of a minimum of 6 and maximum of 24 months, with 21 or less scores on the Montreal Cognitive Assessment Scale(MoCA), who gained the sitting and standing balance and who were able to communicate enough to understand simple orders were included in the study
Who cannot join
- with pre-stroke dementia or Alzheimer's diagnosis, who had vision problems and developed post-stroke aphasia, were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Florence Nightingale Hospital Stroke Center and Şişli Memorial Hospital
Istanbul, Şişli, 34360
About this study
Official title: The Effect of Cognitive Rehabilitation Based on Multicontextual Treatment Approach in Stroke: A Randomized Controlled Trial
BACKGROUND: It is known that cognitive disorders affect the rehabilitation of stroke patients but which cognitive rehabilitation intervention should apply to stroke patients and what their effects are on their life is not clear yet.
OBJECTIVE: to investigate the effects of cognitive rehabilitation including combined approaches on quality of the life and social participation of stroke patients.
METHODS: 20 patients with chronic stroke were randomly divided into two groups (Group 1 and 2), each including 10. Patients in each group were treated with neurophysiological exercises 3 times a week for 8 weeks and the subjects in Group 1 received cognitive rehabilitation additionally. The cognitive rehabilitation program consisted of individualized combined approaches including multicontextual treatment and bottom-up approaches. Loeweinstein Occupational Therapy Cognitive Assessment (LOTCA), Montreal Cognitive Assessment (MoCA) to assess cognitive status, Short Form-36 (SF-36) to assess the quality of life, Functional Independence Measure (FIM) to evaluate functional independence, Canadian Occupational Performance Measure and Craig Handicap Assessment and Reporting Technique- Short Form (CHART-SF) to evaluate social participation were used.
Read the detailed description
Forty-two patients who were diagnosed with a stroke by a neurologist were admitted to the Stroke Unit of Sisli Memorial Hospital from November 2011 to April 2014. Our study was conducted on 20 patients who met the inclusion criteria of the study. Informed consent was obtained from each patient before the study. The Ethics Commission of Hacettepe University Senate (application No: 410.01-3346) approved this study. Patients were randomly divided into two groups of 10 people using a random number table. The number of cases was determined to be 10 patients for each group by using the power analysis method. Power analysis was performed based on the LOTCA and MoCA scales which are expected to have the most changes after the therapy. In this small randomized controlled trial (Small RCT); while the first group (CRG) applied a neurophysiological and cognitive rehabilitation therapy consisting of individualized combined approaches including multi-contextual treatment and bottom-up approaches, the second group (CG) implemented only a neurophysiological treatment program as the control group.
The 1st group determined by randomization applied a total of 2 hours-exercise programs consisting of 1-hour-neurophysiological exercise and 1-hour cognitive rehabilitation. The 2nd Group implemented only a 1-hour neuropsychological exercise program. The treatment programs determined for both groups were carried out 3 days a week for a total of 8 weeks. Cognitive rehabilitation sessions of the 1st group included 30 minutes of remedial and functional adaptive approaches and 30 minutes of implementation of Multicontextual treatment intervention.
While determining the cognitive rehabilitation programs of the patients; the weak areas in their cognitive skills were identified by analyzing the tests conducted before the treatment. Restorative approaches consisted of the repetition of pencil-and-paper activities and computer-based exercises according to the weak cognitive skills of the patients determined by the assessments made.
While determining a specific multi-contextual treatment intervention for the patients; their roles, personalities, habits, interests, requests, living conditions, and environments were questioned, the activities determined by COPM were revised and the essential requirements of this approach tried to be ensured.
According to this approach, using multiple environments and conditions, transfer of learning, and increasing the patient's awareness were provided. Also, the usage of various strategies and associating the new knowledge with the old knowledge were emphasized
- Conditions
- Stroke, Cognitive Impairment, Quality of Life
- Being tested
- neurophysiological exercise, cognitive rehabilitation
- Keywords
- social participation, occupational therapy, stroke, cognition, quality of life
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurophysiological exerciseOther
The content of the treatment program consisted of neurophysiological exercises based on Bobath.
cognitive rehabilitationOther
Cognitive rehabilitation sessions of the experimental group included 30 minutes of remedial and functional adaptive approaches and 30 minutes of implementation of Multicontextual treatment intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The Experimental group was applied a total of 2 hours-exercise programs consisting of 1-hour-neurophysiological exercise and 1-hour cognitive rehabilitation Receives: Other: neurophysiological exercise; Other: cognitive rehabilitation |
| Control Group | Active comparator | The Control Group was implemented only 1-hour neuropsychological exercise program. Receives: Other: neurophysiological exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change outcome measure: Montreal Cognitive Assessment
It has been developed to assess mild cognitive impairments, assesses several cognitive domains; executive functions, visuo-constructional skills, memory, language, attention and concentration, conceptual thinking, calculations, and orientation
Measured: pre-treatment and 8 weeks
Change outcome measure: Loewenstein Occupational Therapy Cognitive Assessment
It has been developed to assess the basic cognitive skills in individuals with a brain damage that is caused by traumatic head injuries, stroke, and brain tumors.The LOTCA scale, the validity of which has been proved by the conducted studies so far, consists of a total of 26 subtests within 6 main areas: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, and thinking operations. A high score indicates complete cognitive skills.
Measured: pre-treatment and 8 weeks
Change outcome measure: Canadian Occupational Performance Measure (COPM)
The COPM is a reliable and valid semi-structured interview measurement tool. Its reliability and validity in the patient groups with stroke have been proved.A high score indicates high performance and satisfaction.
Measured: pre-treatment and 8 weeks
Secondary outcomes (2)
Change outcome measure: Craig HandicapAssessment and Reporting Technique-Short Form-(CHART-SF)
It has developed to determine individuals' level of disability in their social lives, is isused for various populations such as stroke, spinal cord injury, traumatic brain injury, and multiple sclerosis. The maximum score of 100 represents the level of participation of the person without a disability.
Measured: pre-treatment and 8 weeks
Change outcome measure: Functional Independence Measure (FIM)
Consisting of 18 items, the FIM has two main sections that evaluate motor (13 items) and cognitive functions (5 items). These two main sections are also evaluated with subgroups within themselves. A high score indicates complete independence.
Measured: pre-treatment and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start4 Jul 2011
- Primary completion29 Aug 2011
- Study completion13 Jun 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ozden erkan
- Sponsor type
- University, hospital or other
- Collaborators
- Florence Nightingale Hospital, Istanbul, Memorial Sisli Hospital, Istanbul
- Responsible party
- Sponsor-investigator, ozden erkan, Istanbul Medipol University Hospital
- Investigators
- Özden E OGUL, PhD, Principal investigator, Medipol UniversityGonca BUMIN, PhD, Study chair, Hacettepe UniversityYakup KRESPİ, MD, Study director, Istınye University /Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186661
- Sponsor's protocol ID
- 410-01-3346
- Status last verified
- Dec 2023
- First submitted
- 2 Sep 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Rehabilitation Based on Multicontextual Treatment Approach in Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06186661
- Acronym / sponsor ID
- 410-01-3346
- Conditions
- Stroke, Cognitive Impairment, Quality of Life
- Keywords
- social participation, occupational therapy, stroke, cognition, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ozden erkanUniversity, hospital or other
- Collaborators
- Florence Nightingale Hospital, Istanbul, Memorial Sisli Hospital, Istanbul
- Study start
- 4 Jul 2011 (actual)
- Primary completion
- 29 Aug 2011 (actual)
- Study completion
- 13 Jun 2014 (actual)
- First posted
- 2 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.
BACKGROUND: It is known that cognitive disorders affect the rehabilitation of stroke patients but which cognitive rehabilitation intervention should apply to stroke patients and what their effects are on their life is not clear yet.
OBJECTIVE: to investigate the effects of cognitive rehabilitation including combined approaches on quality of the life and social participation of stroke patients.
METHODS: 20 patients with chronic stroke were randomly divided into two groups (Group 1 and 2), each including 10. Patients in each group were treated with neurophysiological exercises 3 times a week for 8 weeks and the subjects in Group 1 received cognitive rehabilitation additionally. The cognitive rehabilitation program consisted of individualized combined approaches including multicontextual treatment and bottom-up approaches. Loeweinstein Occupational Therapy Cognitive Assessment (LOTCA), Montreal Cognitive Assessment (MoCA) to assess cognitive status, Short Form-36 (SF-36) to assess the quality of life, Functional Independence Measure (FIM) to evaluate functional independence, Canadian Occupational Performance Measure and Craig Handicap Assessment and Reporting Technique- Short Form (CHART-SF) to evaluate social participation were used.
Detailed description
Forty-two patients who were diagnosed with a stroke by a neurologist were admitted to the Stroke Unit of Sisli Memorial Hospital from November 2011 to April 2014. Our study was conducted on 20 patients who met the inclusion criteria of the study. Informed consent was obtained from each patient before the study. The Ethics Commission of Hacettepe University Senate (application No: 410.01-3346) approved this study. Patients were randomly divided into two groups of 10 people using a random number table. The number of cases was determined to be 10 patients for each group by using the power analysis method. Power analysis was performed based on the LOTCA and MoCA scales which are expected to have the most changes after the therapy. In this small randomized controlled trial (Small RCT); while the first group (CRG) applied a neurophysiological and cognitive rehabilitation therapy consisting of individualized combined approaches including multi-contextual treatment and bottom-up approaches, the second group (CG) implemented only a neurophysiological treatment program as the control group.
The 1st group determined by randomization applied a total of 2 hours-exercise programs consisting of 1-hour-neurophysiological exercise and 1-hour cognitive rehabilitation. The 2nd Group implemented only a 1-hour neuropsychological exercise program. The treatment programs determined for both groups were carried out 3 days a week for a total of 8 weeks. Cognitive rehabilitation sessions of the 1st group included 30 minutes of remedial and functional adaptive approaches and 30 minutes of implementation of Multicontextual treatment intervention.
While determining the cognitive rehabilitation programs of the patients; the weak areas in their cognitive skills were identified by analyzing the tests conducted before the treatment. Restorative approaches consisted of the repetition of pencil-and-paper activities and computer-based exercises according to the weak cognitive skills of the patients determined by the assessments made.
While determining a specific multi-contextual treatment intervention for the patients; their roles, personalities, habits, interests, requests, living conditions, and environments were questioned, the activities determined by COPM were revised and the essential requirements of this approach tried to be ensured.
According to this approach, using multiple environments and conditions, transfer of learning, and increasing the patient's awareness were provided. Also, the usage of various strategies and associating the new knowledge with the old knowledge were emphasized
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: neurophysiological exercise, Other: cognitive rehabilitationThe Experimental group was applied a total of 2 hours-exercise programs consisting of 1-hour-neurophysiological exercise and 1-hour cognitive rehabilitation |
| Control Group | Active comparator | Other: neurophysiological exerciseThe Control Group was implemented only 1-hour neuropsychological exercise program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with the first time diagnosis of stroke, between 18-80 age range, a post-stroke period of a minimum of 6 and maximum of 24 months, with 21 or less scores on the Montreal Cognitive Assessment Scale(MoCA), who gained the sitting and standing balance and who were able to communicate enough to understand simple orders were included in the study
Key exclusion criteria (1 listed)
- with pre-stroke dementia or Alzheimer's diagnosis, who had vision problems and developed post-stroke aphasia, were excluded from the study.
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 |
|---|---|---|
| neurophysiological exerciseThe content of the treatment program consisted of neurophysiological exercises based on Bobath. | Other | Control Group, Experimental Group |
| cognitive rehabilitationCognitive rehabilitation sessions of the experimental group included 30 minutes of remedial and functional adaptive approaches and 30 minutes of implementation of Multicontextual treatment intervention. | Other | Experimental Group |
Primary outcome
Change outcome measure: Montreal Cognitive Assessment
Time frame: pre-treatment and 8 weeks
It has been developed to assess mild cognitive impairments, assesses several cognitive domains; executive functions, visuo-constructional skills, memory, language, attention and concentration, conceptual thinking, calculations, and orientation
Change outcome measure: Loewenstein Occupational Therapy Cognitive Assessment
Time frame: pre-treatment and 8 weeks
It has been developed to assess the basic cognitive skills in individuals with a brain damage that is caused by traumatic head injuries, stroke, and brain tumors.The LOTCA scale, the validity of which has been proved by the conducted studies so far, consists of a total of 26 subtests within 6 main areas: orientation, visual perception, spatial perception, motor praxis, visuomotor organization, and thinking operations. A high score indicates complete cognitive skills.
Change outcome measure: Canadian Occupational Performance Measure (COPM)
Time frame: pre-treatment and 8 weeks
The COPM is a reliable and valid semi-structured interview measurement tool. Its reliability and validity in the patient groups with stroke have been proved.A high score indicates high performance and satisfaction.
2 secondary outcomes
Change outcome measure: Craig HandicapAssessment and Reporting Technique-Short Form-(CHART-SF)
Time frame: pre-treatment and 8 weeks
Change outcome measure: Functional Independence Measure (FIM)
Time frame: pre-treatment and 8 weeks
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 2 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Özden E OGUL, PhD principal investigator
Medipol University
Gonca BUMIN, PhD study chair
Hacettepe University
Yakup KRESPİ, MD study director
Istınye University /Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurophysiological exercise and cognitive rehabilitation in people with Stroke and Cognitive Impairment, run by ozden erkan 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 1 inclusion and 1 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 2 Jan 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?
Change outcome measure: Montreal Cognitive Assessment (time frame: pre-treatment and 8 weeks). The study lists 3 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 2 Jan 2024.