Stroke, AcuteNCT03602326
Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective
A study testing Neurodevelopmental Therapy-Bobath group and Standart Rehabilitation Group (SR group) in people with Stroke, Acute and Ischemic Stroke, run by Gokhan Yazici at 1 site in Turkey (Türkiye).
Trial summary
Early term rehabilitation initiated after stroke should be based on motor learning principles and neural plasticity. To achieve motor learning and neural plasticity, exercises consisting of intense and repetitive training should be given according to the patients' functional level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Ischemic Stroke
- What is being tested?
- Neurodevelopmental Therapy-Bobath group and Standart Rehabilitation Group (SR group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 13 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age
- Systolic blood pressure between 120 and 220 mmHg
- Oxygen saturation >92% (with or without O2 support)
- A heart rate of 40 to 100 beats/min
- A body temperature of <38.5°C
- A disability level of ≤4 according to the Modified Rankin Scale
- Those who could respond to verbal commands
Who cannot join
- A history of previous stroke
- Concomitant progressive neurological disturbances
- Acute coronary disease
- Severe heart failure
- Concomitant rheumatologic diseases
- A fracture or an acute orthopedic disorder that would prevent mobilization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Department of Neurology
Ankara, 06560
About this study
Early term rehabilitation initiated after stroke should be based on motor learning principles and neural plasticity. To achieve motor learning and neural plasticity, exercises consisting of intense and repetitive training should be given according to the patients' functional level. The neurodevelopmental treatment-Bobath (NDT_B) approach is based on motor learning principles. In literature, studies that show the early term effects of NDT-B on functional recovery are inadequate. The aim of this study was to investigate the effects NDT-B applied in the early term of stroke, on postural control, functional movement, balance and activities of daily living.
Read the detailed description
When literature is examined, it can be seen that evidence is limited. Studies investigating the effects of the Bobath Approach in the early term in stroke, state that NDT-B is reliable and feasible. However none of these studies have examined the effects of NDT-B in acute term stroke on functionality and daily living. Additionally, in all of these studies it was also stated that further studies should be conducted.
- Conditions
- Stroke, Acute, Ischemic Stroke
- Being tested
- Neurodevelopmental Therapy-Bobath group, Standart Rehabilitation Group (SR group)
- Keywords
- Stroke, Early term, Bobath, Neurodevelopmental treatment, Rehabilitation
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental Therapy-Bobath groupOther
Neurodevelopmental Therapy-Bobath (NDT-B) is one of the most commonly used models for therapeutic management and treatment in patients with stroke. The basic philosophy underlying this approach is that; lesions in the central nervous system cause impairments in the coordination of movement and posture combined with problems in muscle tone which lead directly to functional limitations. According to the NDT-B approach, practice has a great role in treatment due to the fact that more practice leads to better motor learning and increases neural plasticity. According to NDT-B, the duration of treatment should not be limited to rehabilitation sessions, but should be designed to be implied throughout the day and should be adapted to the patients' daily life.
Standart Rehabilitation Group (SR group)Other
Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine.
| Study group | Role | What they receive |
|---|---|---|
| Neurodevelopmental Therapy-Bobath group | Experimental | Bobath Approach Principles and exercises will be performed 5 days a week with physical therapists and everyday with caregivers. Physiotherapy will be initiated as early as possible according to the principles of the method by experienced NDT-B therapists. Exercises will be implemented according to the patients' status and will be used to maintain and improve muscle strength and endurance. Both the unaffected and affected side will be included in rehabilitation. The exercises given are designed to be simple, understandable, task-oriented and repetitive, in accordance with the Bobath approach and the functional state of the patient at that time. In order to prevent motor amnesia and neglect of the affected side, correct positioning and sensory input will be provided since the first session. Receives: Other: Neurodevelopmental Therapy-Bobath group |
| Standart Rehabilitation Group (SR group) | Active comparator | Patients will be included in standard rehabilitation sessions, 5 days per week. The rehabilitation sessions will be performed by standard clinical physiotherapists according to the hospital routine. The rehabilitation program will consist of in-bed joint range of motion exercises and bedside mobilization applications. The patients will be included in the rehabilitation program as early as possible and the program will continue until the patients are discharged Receives: Other: Standart Rehabilitation Group (SR group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stroke Rehabilitation Assessment of Movement Scale
The Stroke Rehabilitation Assessment of Movement Scale (STREAM) was used to assess functional movements and mobility. The scale consists of two subsections and a total of 30 tests evaluating the performance and the quality of the individual's voluntary limb movements (20 tests) and basic mobility activities (10 tests). The total score will be used for assessment in this study. The total score is 70. A high score indicates less motor impairment, while a lower score indicates increased motor impairment.
Measured: Change from Baseline functional movements at 10 days
Secondary outcomes (3)
The Trunk Impairment scale
The Trunk Impairment scale (TIS) was used to assess sitting balance and postural control. TIS consists of 3 sections and 17 tests evaluating static-dynamic sitting balance and coordination. The total score will be used for assessment in this study. The total score is 23. A higher score indicates better control of the trunk, while a lower score indicates poor postural trunk control.
Measured: Change from Baseline sitting balance and postural control at 10 days
The Functional Ambulation Classification
The Functional Ambulation Classification (FAC) is a method for classifying gait mobility in neurologically impaired patients. The FAC has six categories ranging from 0 to 5. A higher score indicates independence in ambulation, while a lower score indicates the person has non-functional ambulation. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.
Measured: Change from Baseline level of functional ambulance at 10 days
The Berg Balance Scale
The Berg Balance Scale (BBS) was used to assess functional balance. BBS consists of 14 tests evaluating balance during; postural changes, at different positions and during movement. Each test is rated from 0 to 4. The total score will be used for assessment in this study. The highest score is 56; 0-20 point indicates a balance disorder (high risk of falls), 21-40 points indicates an acceptable balance (moderate risk of falls), 41-56 points indicates good balance (low risk of falling)
Measured: Change from Baseline functional balance at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 May 2018
- Primary completion6 Jul 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Model description
- Patients admitted to Gazi University Hospital with stroke findings diagnosed with ischemic stroke by a Neurologist will be included in the study. Patients older than 18 years of age with a systolic blood pressure between 120 and 220 mmHg, whose oxygen saturation is \>92% (with or without O2 support), with a heart rate of 40 to 100 beats/min, a body temperature of \<38.5°C, a disability level of ≤4 according to the Modified Rankin Scale and those who could respond to verbal commands will be included in the study. Patients with; a history of previous stroke or any other disorder that would prevent mobilization will not be included in the study. The patients will be randomly divided into two groups: NDT-B Group and the Standard Rehabilitation Group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gokhan Yazici
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gokhan Yazici, Gazi University
- Investigators
- Gokhan Yazici, Ph.D., Principal investigator, Gazi University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602326
- Sponsor's protocol ID
- 196
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- 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 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective
- ClinicalTrials.gov ID
- NCT03602326
- Acronym / sponsor ID
- 196
- Conditions
- Stroke, Acute, Ischemic Stroke
- Keywords
- Stroke, Early term, Bobath, Neurodevelopmental treatment, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Gokhan YaziciUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 26 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.
Early term rehabilitation initiated after stroke should be based on motor learning principles and neural plasticity. To achieve motor learning and neural plasticity, exercises consisting of intense and repetitive training should be given according to the patients' functional level. The neurodevelopmental treatment-Bobath (NDT_B) approach is based on motor learning principles. In literature, studies that show the early term effects of NDT-B on functional recovery are inadequate. The aim of this study was to investigate the effects NDT-B applied in the early term of stroke, on postural control, functional movement, balance and activities of daily living.
Detailed description
When literature is examined, it can be seen that evidence is limited. Studies investigating the effects of the Bobath Approach in the early term in stroke, state that NDT-B is reliable and feasible. However none of these studies have examined the effects of NDT-B in acute term stroke on functionality and daily living. Additionally, in all of these studies it was also stated that further studies should be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients admitted to Gazi University Hospital with stroke findings diagnosed with ischemic stroke by a Neurologist will be included in the study. Patients older than 18 years of age with a systolic blood pressure between 120 and 220 mmHg, whose oxygen saturation is >92% (with or without O2 support), with a heart rate of 40 to 100 beats/min, a body temperature of <38.5°C, a disability level of ≤4 according to the Modified Rankin Scale and those who could respond to verbal commands will be included in the study. Patients with; a history of previous stroke or any other disorder that would prevent mobilization will not be included in the study. The patients will be randomly divided into two groups: NDT-B Group and the Standard Rehabilitation Group.
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental Therapy-Bobath group | Experimental | Other: Neurodevelopmental Therapy-Bobath groupBobath Approach Principles and exercises will be performed 5 days a week with physical therapists and everyday with caregivers. Physiotherapy will be initiated as early as possible according to the principles of the method by experienced NDT-B therapists. Exercises will be implemented according to the patients' status and will be used to maintain and improve muscle strength and endurance. Both the unaffected and affected side will be included in rehabilitation. The exercises given are designed to be simple, understandable, task-oriented and repetitive, in accordance with the Bobath approach and the functional state of the patient at that time. In order to prevent motor amnesia and neglect of the affected side, correct positioning and sensory input will be provided since the first session. |
| Standart Rehabilitation Group (SR group) | Active comparator | Other: Standart Rehabilitation Group (SR group)Patients will be included in standard rehabilitation sessions, 5 days per week. The rehabilitation sessions will be performed by standard clinical physiotherapists according to the hospital routine. The rehabilitation program will consist of in-bed joint range of motion exercises and bedside mobilization applications. The patients will be included in the rehabilitation program as early as possible and the program will continue until the patients are discharged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients older than 18 years of age
- Systolic blood pressure between 120 and 220 mmHg
- Oxygen saturation >92% (with or without O2 support)
- A heart rate of 40 to 100 beats/min
- A body temperature of <38.5°C
Key exclusion criteria (6 listed)
- A history of previous stroke
- Concomitant progressive neurological disturbances
- Acute coronary disease
- Severe heart failure
- Concomitant rheumatologic diseases
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 |
|---|---|---|
| Neurodevelopmental Therapy-Bobath groupNeurodevelopmental Therapy-Bobath (NDT-B) is one of the most commonly used models for therapeutic management and treatment in patients with stroke. The basic philosophy underlying this approach is that; lesions in the central nervous system cause impairments in the coordination of movement and posture combined with problems in muscle tone which lead directly to functional limitations. According to the NDT-B approach, practice has a great role in treatment due to the fact that more practice leads to better motor learning and increases neural plasticity. According to NDT-B, the duration of treatment should not be limited to rehabilitation sessions, but should be designed to be implied throughout the day and should be adapted to the patients' daily life. | Other | Neurodevelopmental Therapy-Bobath group |
| Standart Rehabilitation Group (SR group)Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine. | Other | Standart Rehabilitation Group (SR group) |
Primary outcome
The Stroke Rehabilitation Assessment of Movement Scale
Time frame: Change from Baseline functional movements at 10 days
The Stroke Rehabilitation Assessment of Movement Scale (STREAM) was used to assess functional movements and mobility. The scale consists of two subsections and a total of 30 tests evaluating the performance and the quality of the individual's voluntary limb movements (20 tests) and basic mobility activities (10 tests). The total score will be used for assessment in this study. The total score is 70. A high score indicates less motor impairment, while a lower score indicates increased motor impairment.
3 secondary outcomes
The Trunk Impairment scale
Time frame: Change from Baseline sitting balance and postural control at 10 days
The Functional Ambulation Classification
Time frame: Change from Baseline level of functional ambulance at 10 days
The Berg Balance Scale
Time frame: Change from Baseline functional balance at 10 days
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 26 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.
Gokhan Yazici, Ph.D. principal investigator
Gazi University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Therapy-Bobath group and Standart Rehabilitation Group (SR group) in people with Stroke, Acute and Ischemic Stroke, run by Gokhan Yazici 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 7 inclusion and 6 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 26 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 Scale (time frame: Change from Baseline functional movements at 10 days). 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 26 Jul 2018.