Functional Outcomes of The Bobath Approach on Patients With Brain Tumors: Comparison With Stroke Patients

Functional Outcomes of The Bobath Neurodevelopmental Treatment Approach Applied to Patients With Brain Tumors: Comparison With Stroke Patients

The aim of this study is to examine the functional recovery results of the Bobath (NDT) approach in patients with primary brain tumors and compare the results with those of stroke patients.

Study Overview

• Status: Completed
• Conditions: Brain Neoplasms; Stroke, Acute
• Intervention / Treatment: Behavioral: Bobath Neurodevelopmental Treatment Approach

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey, 06511
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Department of Neurology between June 2016 and April 2017, were analyzed for the study. The study inclusion criteria were determined for all patients to be over 18 years of age, in the acute phase, Glasgow Coma Scale score 14 and above, Modifiye Rankin Score being more than 2 and medical stability. Furthermore, the criteria for inclusion in the study were unilateral stroke and having a stroke for the first time for stroke patients, and supratentorial location for patients with brain tumors.

Description

Inclusion Criteria:

• acute phase patients with brain tumor and stroke in after surgery

Exclusion Criteria:

• Modified rankin scale <2
• High grade tumor
• Infratentorial tumor
• GCS<14
• Rehabilitation session time<3
• Second or more tumor surgery
• Second or more stroke
• Bilateral stroke

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bobath Approach Applied to Patient with Brain Tumors	Behavioral: Bobath Neurodevelopmental Treatment Approach; The Bobath Neurodevelopmental Treatment (NDT) rehabilitation approach is effective in increasing the functional capacity and acquiring independence in patients with stroke and brain tumor.
Bobath Approach Applied to Patient with Stroke	Behavioral: Bobath Neurodevelopmental Treatment Approach; The Bobath Neurodevelopmental Treatment (NDT) rehabilitation approach is effective in increasing the functional capacity and acquiring independence in patients with stroke and brain tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Stroke Rehabilitation Assessment of Movement Measure (STREAM)	The Stroke Rehabilitation Assessment of Movement Measure (STREAM) is a scale with scores ranging from 0 to 70, which is used to provide an understanding of the levels of movement and quality of hemiplegic patients.	Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Functional Independent Measurement (FIM)	The Functional Independent Measurement (FIM) is 18-item scale and is scored from 18 (total assistance in all areas) to 126 (complete independence). FIM consists of 13 motor (or physical) and 5 social-cognitive items, assessing self care, sphincter control, transfer, locomotion, communication, social interaction, and cognition. The results from the first 13 items (FIM motor) are summed to develop a motor score with a range of 13 to 91, and these items were used in this study.	Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.
Mini-Mental State Examination (MMSE)	Mini-Mental State Examination (MMSE) is a scale with scores ranging from 0 to 30, which allows the cognitive levels to be determined by examining the patient's orientation, recording memory, attention and calculation, recall, and language parameters. The score of 0 indicates that the patient has no cognitive functions, and the score of 30 indicates that the patient has a high level of cognitive functions.	Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): June 12, 2018

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; brain neoplasms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Stroke; Brain Neoplasms
• Other Study ID Numbers: GO 18/25-13

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