Brain NeoplasmsNCT03574467
Functional Outcomes of The Bobath Approach on Patients With Brain Tumors: Comparison With Stroke Patients
An observational study of Brain Neoplasms and Stroke, Acute, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the functional recovery results of the Bobath (NDT) approach in patients with primary brain tumors and compare the results with those of stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Stroke, Acute
- What is being tested?
- Bobath Neurodevelopmental Treatment Approach
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2018to 12 Jun 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of Neurology between June 2016 and April 2017, were analyzed for the study. The study inclusion criteria were determined for all patients to be over 18 years of age, in the acute phase, Glasgow Coma Scale score 14 and above, Modifiye Rankin Score being more than 2 and medical stability. Furthermore, the criteria for inclusion in the study were unilateral stroke and having a stroke for the first time for stroke patients, and supratentorial location for patients with brain tumors.
Who may be able to join
- acute phase patients with brain tumor and stroke in after surgery
Who cannot join
- Modified rankin scale <2
- High grade tumor
- Infratentorial tumor
- GCS<14
- Rehabilitation session time<3
- Second or more tumor surgery
- Second or more stroke
- Bilateral stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcomes of The Bobath Neurodevelopmental Treatment Approach Applied to Patients With Brain Tumors: Comparison With Stroke Patients
The aim of this study is to examine the functional recovery results of the Bobath (NDT) approach in patients with primary brain tumors and compare the results with those of stroke patients.
- Conditions
- Brain Neoplasms, Stroke, Acute
- Being tested
- Bobath Neurodevelopmental Treatment Approach
- Keywords
- brain neoplasms, stroke, rehabilitation
- Medical subject headings
- Brain Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath Neurodevelopmental Treatment ApproachBehavioural
The Bobath Neurodevelopmental Treatment (NDT) rehabilitation approach is effective in increasing the functional capacity and acquiring independence in patients with stroke and brain tumor.
| Study group | Role | What they receive |
|---|---|---|
| Bobath Approach Applied to Patient with Brain Tumors | Not described Receives: Behavioral: Bobath Neurodevelopmental Treatment Approach | |
| Bobath Approach Applied to Patient with Stroke | Not described Receives: Behavioral: Bobath Neurodevelopmental Treatment Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stroke Rehabilitation Assessment of Movement Measure (STREAM)
The Stroke Rehabilitation Assessment of Movement Measure (STREAM) is a scale with scores ranging from 0 to 70, which is used to provide an understanding of the levels of movement and quality of hemiplegic patients.
Measured: Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.
Secondary outcomes (2)
The Functional Independent Measurement (FIM)
The Functional Independent Measurement (FIM) is 18-item scale and is scored from 18 (total assistance in all areas) to 126 (complete independence). FIM consists of 13 motor (or physical) and 5 social-cognitive items, assessing self care, sphincter control, transfer, locomotion, communication, social interaction, and cognition. The results from the first 13 items (FIM motor) are summed to develop a motor score with a range of 13 to 91, and these items were used in this study.
Measured: Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.
Mini-Mental State Examination (MMSE)
Mini-Mental State Examination (MMSE) is a scale with scores ranging from 0 to 30, which allows the cognitive levels to be determined by examining the patient's orientation, recording memory, attention and calculation, recall, and language parameters. The score of 0 indicates that the patient has no cognitive functions, and the score of 30 indicates that the patient has a high level of cognitive functions.
Measured: Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start15 Feb 2018
- Primary completion10 Apr 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Turkmen, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574467
- Sponsor's protocol ID
- GO 18/25-13
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 2 Jul 2018
- 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 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of The Bobath Neurodevelopmental Treatment Approach Applied to Patients With Brain Tumors: Comparison With Stroke Patients
- ClinicalTrials.gov ID
- NCT03574467
- Acronym / sponsor ID
- GO 18/25-13
- Conditions
- Brain Neoplasms, Stroke, Acute
- Keywords
- brain neoplasms, stroke, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 2 Jul 2018 (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 this study is to examine the functional recovery results of the Bobath (NDT) approach in patients with primary brain tumors and compare the results with those of stroke patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bobath Approach Applied to Patient with Brain Tumors | – | Behavioral: Bobath Neurodevelopmental Treatment Approach |
| Bobath Approach Applied to Patient with Stroke | – | Behavioral: Bobath Neurodevelopmental Treatment Approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Neurology between June 2016 and April 2017, were analyzed for the study. The study inclusion criteria were determined for all patients to be over 18 years of age, in the acute phase, Glasgow Coma Scale score 14 and above, Modifiye Rankin Score being more than 2 and medical stability. Furthermore, the criteria for inclusion in the study were unilateral stroke and having a stroke for the first time for stroke patients, and supratentorial location for patients with brain tumors.
Key inclusion criteria (1 listed)
- acute phase patients with brain tumor and stroke in after surgery
Key exclusion criteria (8 listed)
- Modified rankin scale <2
- High grade tumor
- Infratentorial tumor
- GCS<14
- Rehabilitation session time<3
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 |
|---|---|---|
| Bobath Neurodevelopmental Treatment ApproachThe Bobath Neurodevelopmental Treatment (NDT) rehabilitation approach is effective in increasing the functional capacity and acquiring independence in patients with stroke and brain tumor. | Behavioural | Bobath Approach Applied to Patient with Brain Tumors, Bobath Approach Applied to Patient with Stroke |
Primary outcome
The Stroke Rehabilitation Assessment of Movement Measure (STREAM)
Time frame: Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.
The Stroke Rehabilitation Assessment of Movement Measure (STREAM) is a scale with scores ranging from 0 to 70, which is used to provide an understanding of the levels of movement and quality of hemiplegic patients.
2 secondary outcomes
The Functional Independent Measurement (FIM)
Time frame: Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.
Mini-Mental State Examination (MMSE)
Time frame: Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.
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 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Brain Neoplasms and Stroke, Acute, run by Hacettepe 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 1 inclusion and 8 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 Jul 2018. 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?
The Stroke Rehabilitation Assessment of Movement Measure (STREAM) (time frame: Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.). 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 Jul 2018.