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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04700982
Other study ID # 94603339-604.01.02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 7, 2020
Est. completion date November 1, 2020

Study information

Verified date December 2020
Source Baskent University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate whether the length of hospital stay for rehabilitation affects functional outcomes of stroke patients.


Description:

The medical records of patients who were admitted to a rehabilitation unit were analyzed retrospectively. The functional output, the level of spasticity, and the level of motor development at admission and discharge will be determined using the Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test, respectively. Based on the length of hospital stay, patients will be divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2). Clinical features and functional output will be compared between the groups.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date November 1, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of stroke - must be able to receive rehabilitation in an inpatient clinic between 2010 and 2013 Exclusion Criteria: - previous history of stroke, - other neurological diseases, - amputation, - severe arthritis - undergoing hemodialysis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Based on the length of hospital stay
Based on the length of hospital stay, patients were divided into two groups: hospital stays = 3 months (Group 1) and > 3 months (Group 2).Clinical features and functional output will be then compared between the groups.

Locations

Country Name City State
Turkey Kirklareli Univesity Kirklareli

Sponsors (1)

Lead Sponsor Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Balaban B, Tok F, Yavuz F, Yasar E, Alaca R. Early rehabilitation outcome in patients with middle cerebral artery stroke. Neurosci Lett. 2011 Jul 12;498(3):204-7. doi: 10.1016/j.neulet.2011.05.009. Epub 2011 May 11. — View Citation

Foulkes MA, Wolf PA, Price TR, Mohr JP, Hier DB. The Stroke Data Bank: design, methods, and baseline characteristics. Stroke. 1988 May;19(5):547-54. — View Citation

Hebert D, Lindsay MP, McIntyre A, Kirton A, Rumney PG, Bagg S, Bayley M, Dowlatshahi D, Dukelow S, Garnhum M, Glasser E, Halabi ML, Kang E, MacKay-Lyons M, Martino R, Rochette A, Rowe S, Salbach N, Semenko B, Stack B, Swinton L, Weber V, Mayer M, Verrilli S, DeVeber G, Andersen J, Barlow K, Cassidy C, Dilenge ME, Fehlings D, Hung R, Iruthayarajah J, Lenz L, Majnemer A, Purtzki J, Rafay M, Sonnenberg LK, Townley A, Janzen S, Foley N, Teasell R. Canadian stroke best practice recommendations: Stroke rehabilitation practice guidelines, update 2015. Int J Stroke. 2016 Jun;11(4):459-84. doi: 10.1177/1747493016643553. Epub 2016 Apr 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical features and Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test outcomes will be then compared between the groups. Demographic features, clinical features and Functional Independence Measure (FIM) instrument, the Modified Ashworth Scale (MAS), and the Brunnstrom test outcomes will be documented for all patients. The FIM includes 18 items with higher scores indicating greater independence. The motor development of the upper extremity, hand, and lower extremity will be evaluated using the Brunnstrom test with higher stages indicating greater development. The degree of spasticity of the upper and lower extremity muscles will be assessed using the MAS with high stage indicating greater spasticity.
All patients will be divided into two groups based on length of hospital stay. Clinical features, demographic features and FIM, MAS, and the Brunnstrom test outcomes will be then compared between the groups. All data for normality were tested with Kolmogorov-Smirnov tests. Mann-Whitney U tests will be used for comparison of the differences between the two groups.
through study completion, an average of 1 month
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