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

NCT ID: NCT03602326

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-07-13

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.

Conditions

Stroke, Acute; Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neurodevelopmental Therapy-Bobath group

Intervention Type: OTHER

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)

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

Group Type: ACTIVE_COMPARATOR

Standart Rehabilitation Group (SR group)

Intervention Type: OTHER

Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine.

Interventions

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.

Intervention Type: OTHER

Standart Rehabilitation Group (SR group)

Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gokhan Yazici

OTHER

Sponsor Role: lead

Responsible Party

Gokhan Yazici

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gokhan Yazici, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Gazi University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation, Ankara, Turkey

Locations

Gazi University Hospital, Department of Neurology

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

196

Identifier Type: -

Identifier Source: org_study_id