Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective

July 18, 2018 updated by: Gokhan Yazici
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Gazi University Hospital, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neurodevelopmental Therapy-Bobath group
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.
Other: Neurodevelopmental Therapy-Bobath group
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.
Active Comparator: 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
Other: Standart Rehabilitation Group (SR group)
Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline functional movements at 10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Trunk Impairment scale
Time Frame: Change from Baseline sitting balance and postural control at 10 days
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.
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 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.
Change from Baseline level of functional ambulance at 10 days
The Berg Balance Scale
Time Frame: Change from Baseline functional balance at 10 days
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)
Change from Baseline functional balance at 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gokhan Yazici

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gokhan Yazici, Ph.D., Gazi University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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