Back to resultsNeurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective
Primary Purpose
Stroke, Acute, Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neurodevelopmental Therapy-Bobath group
Standart Rehabilitation Group (SR group)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring Stroke, Early term, Bobath, Neurodevelopmental treatment, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Gazi University Hospital, Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neurodevelopmental Therapy-Bobath group
Standart Rehabilitation Group (SR group)
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03602326
Brief Title
Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective
Official Title
Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gokhan Yazici
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Ischemic Stroke
Keywords
Stroke, Early term, Bobath, Neurodevelopmental treatment, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurodevelopmental Therapy-Bobath group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standart Rehabilitation Group (SR group)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental Therapy-Bobath group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standart Rehabilitation Group (SR group)
Intervention Description
Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine.
Primary Outcome Measure Information:
Title
The Stroke Rehabilitation Assessment of Movement Scale
Description
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.
Time Frame
Change from Baseline functional movements at 10 days
Secondary Outcome Measure Information:
Title
The Trunk Impairment scale
Description
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.
Time Frame
Change from Baseline sitting balance and postural control at 10 days
Title
The Functional Ambulation Classification
Description
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.
Time Frame
Change from Baseline level of functional ambulance at 10 days
Title
The Berg Balance Scale
Description
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)
Time Frame
Change from Baseline functional balance at 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokhan Yazici, Ph.D.
Organizational Affiliation
Gazi University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University Hospital, Department of Neurology
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective
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