NCT03574467

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

June 11, 2018

Last Update Submit

June 20, 2018

Conditions

Keywords

brain neoplasmsstrokerehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Functional Independent Measurement (FIM)

    Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.

  • Mini-Mental State Examination (MMSE)

    Patients were evaluated immediately before rehabilitation, and immediately after rehabilitation service, which lasted 4-10 days on average.

Study Arms (2)

Bobath Approach Applied to Patient with Brain Tumors

Behavioral: Bobath Neurodevelopmental Treatment Approach

Bobath Approach Applied to Patient with Stroke

Behavioral: Bobath Neurodevelopmental Treatment Approach

Interventions

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 Brain TumorsBobath Approach Applied to Patient with Stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06511, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain NeoplasmsStroke

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 2, 2018

Study Start

February 15, 2018

Primary Completion

April 10, 2018

Study Completion

June 12, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations