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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03574467
Other study ID # GO 18/25-13
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2018
Est. completion date June 12, 2018

Study information

Verified date June 2018
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date June 12, 2018
Est. primary completion date April 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Hacettepe University Ankara Altindag

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
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