Inter-Tester Reliability Of the Cumulated Ambulation Score in Patients With Stroke (InTRO-CAS-stroke)

NCT05601089 | Completed

• 1 other identifier: P-2022-518
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

CAS is a measurement of basic mobility describing the degree of independence in three activities; getting in and out of bed, sit-to-stand from a chair with armrests, and indoor walking - each assessed on a three-point ordinal scale (0-2), resulting in a total one-day CAS between 0-6 points. Psychometric properties of the CAS has not been investigated i stroke. The design is an inter-tester reliability study.

Conditions

Stroke

Keywords

Reliability; Cumulated Ambulation Score; Stroke; Inter-rater reliability; Inter-tester reliability

Outcome Measures

Primary Outcomes (1)

• Inter-tester reliability of the Cumulated Ambulation Score

  Agreement, percentage agreement, and linear weighted kappa between two CAS will be used for both the three activities independently and the total CAS-score to assess relative inter-tester reliability. Systematic between rater bias will be evaluated with the students t-test/Mann Whitney, as appropriate, and illustrated in a Bland Altman Plot. Furthermore, floor/ceiling of CAS sores will be assessed. Absolute reliability will assessed by intraclass correlation coefficient, standard error of the measurement SEM=SD×√(1-ICC) and the smallest real difference SRD=SEM×1.96×√(2)

  Tested by two raters once in a single session at day 1-4 after stroke onset (day of stroke = day 0). The study will end at completion of study or inclusion of all participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult stroke survivors with the need for rehabilitation and a NIHSS-score of at least 2 at the Copenhagen University Hospital, Bispebjerg

You may qualify if:

• Ischemic or hemorrhagic lesion relevant to this stroke event documented by CT/MRI
• NIHSS ≥ 2
• Patients eligible for physio- and/or occupational therapy planning

You may not qualify if:

• \- Not able to give informed consent

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• University College Copenhagen: collaborator

Study Sites (1)

Department of Physio- and Occupational Therapy

Bispebjerg, Copenhagen, 2400, Denmark

Location

Related Publications (1)

• Arens CH, Johnsen NM, Milanesi M, Weli A, Linnebjerg C, Christensen H, Kristensen MT. Inter-tester reliability and agreement of the Cumulated Ambulation Score in acute stroke: The InTRO-CAS-stroke study. J Stroke Cerebrovasc Dis. 2024 May;33(5):107630. doi: 10.1016/j.jstrokecerebrovasdis.2024.107630. Epub 2024 Feb 5.

  PMID: 38325673 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Morten T. Kristensen, professor

  Department of Physio- and Occupational Therapy, Copenhagen University Hospital, Bispebjerg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 1, 2022
• Study Start: October 24, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

DK (1)