Clinical trial NCT03602326: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Ischemic Stroke
Keywords: Stroke
Early term
Bobath
Neurodevelopmental treatment
Rehabilitation
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Stroke Rehabilitation Assessment of Movement Scale
timeFrame: Change from Baseline functional movements at 10 days
Secondary outcomes:
measure: The Trunk Impairment scale
timeFrame: Change from Baseline sitting balance and postural control at 10 days
measure: The Functional Ambulation Classification
timeFrame: Change from Baseline level of functional ambulance at 10 days
measure: The Berg Balance Scale
timeFrame: Change from Baseline functional balance at 10 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital, Department of Neurology
Study officials:
affiliation: Gazi University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey
name: Gokhan Yazici, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: