NCT04700982

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

December 1, 2020

Enrollment Period

25 days

First QC Date

December 28, 2020

Last Update Submit

January 6, 2021

Conditions

Keywords

Neurological RehabilitationStrokeRehabilitation Outcome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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).

Other: Based on the length of hospital stay

Interventions

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.

Based on the length of hospital stay

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with a stroke who received rehabilitation in an inpatient clinic between 2010 and 2013

You may qualify if:

  • Clinical diagnosis of stroke
  • must be able to receive rehabilitation in an inpatient clinic between 2010 and 2013

You may not qualify if:

  • previous history of stroke,
  • other neurological diseases,
  • amputation,
  • severe arthritis
  • undergoing hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırklareli Univesity

Kırklareli, 39000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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. doi: 10.1161/01.str.19.5.547.

    PMID: 3363586BACKGROUND
  • 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.

    PMID: 21600267BACKGROUND
  • 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.

    PMID: 27079654BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • betül çiftçi tepeli

    Kırklareli University School of Health Department of Physical Medicine and Rehabilitiation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physiotherapy and Rehabilitation of Kırklareli University

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 8, 2021

Study Start

October 7, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

January 8, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations