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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602326
• Other study ID #: 196
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: July 13, 2018

Study information

• Verified date: July 2018
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 13, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

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.
• Standart Rehabilitation Group (SR group)
Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine.

Locations

Country	Name	City	State
Turkey	Gazi University Hospital, Department of Neurology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gokhan Yazici

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline functional movements at 10 days
Secondary	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.	Change from Baseline sitting balance and postural control at 10 days
Secondary	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.	Change from Baseline level of functional ambulance at 10 days
Secondary	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)	Change from Baseline functional balance at 10 days