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

NCT03602326 | Completed

• 1 other identifier: 196
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Ischemic Stroke

Keywords

Stroke; Early term; Bobath; Neurodevelopmental treatment; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Trunk Impairment scale

  Change from Baseline sitting balance and postural control at 10 days

• The Functional Ambulation Classification

  Change from Baseline level of functional ambulance at 10 days

• The Berg Balance Scale

  Change from Baseline functional balance at 10 days

Study Arms (2)

Neurodevelopmental Therapy-Bobath group

EXPERIMENTAL

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

Standart Rehabilitation Group (SR group)

ACTIVE COMPARATOR

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)

Interventions

Neurodevelopmental Therapy-Bobath group 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.

Neurodevelopmental Therapy-Bobath group

Standart Rehabilitation Group (SR group) OTHER

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

Standart Rehabilitation Group (SR group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gokhan Yazici: lead

Study Sites (1)

Gazi University Hospital, Department of Neurology

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gokhan Yazici, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 26, 2018
• Study Start: May 1, 2018
• Primary Completion: July 6, 2018
• Study Completion: July 13, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

TU (1)