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StrokeNCT05601089

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

An observational study of Stroke, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
How many people
60 participants
Where
1 siteDenmark
Study dates
24 Oct 2022to 31 Mar 2023
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Not able to give informed consent

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Department of Physio- and Occupational Therapy

    Bispebjerg, Copenhagen, 2400

Other trials in Denmark

About this study

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.

Read the detailed description

Rationale:

There are 12,000 new cases of stroke every year in Denmark. Stroke is the leading cause of adult disability, and more than 90,000 people are living with stroke. Many stroke survivors are in the need of help from others due to psychological, cognitive, physical, communication and/or swallowing problems. Stroke victims suffer from different impairments, resulting in different activity limitations. In Denmark, all stroke patients are admitted to a specialized acute stroke unit. The rehabilitation, if needed, is commenced within the first 48 hours of admission and continues throughout the hospital stay. In cases where patients need continued rehabilitation at discharge, then the municipality is advised where the rehabilitation continues.

At Copenhagen University Hospital Bispebjerg all patients receiving either physical or occupational therapy (or both) are tested with the Cumulated ambulation Score (CAS) as of 1st of April 2022. Each participant is tested at the beginning of the rehabilitation and before discharge. 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. CAS has shown to be reliable in both hip fracture and geriatric patients and useful in motoring basic mobility in geriatric patients. However, we do not know how reliable the score is in stroke victims. Therefore, the aim of this study is to investigate the inter-tester reliability of the three activities of the CAS and the total CAS.

Methods:

One experienced CAS user (NMJ) and one inexperienced (MM - last semester's physical therapy student) will be involved in the study. To achieve experience in using the CAS, the inexperienced CAS user will follow the experienced user throughout one day in regard to scoring the CAS. This will enable the inexperienced CAS user to get somewhat comfortable in the use of CAS.

Stroke victims experience changes in the basic mobility during the day, and even from hour to hour, due to spontaneous recovery, but also general tiredness and fatigue due to the brain damage can influence performances. Hence, the two therapists will only attend the patient at one session between day 1 and 4 after stroke onset, as soon as possible. Stroke victims will be tested after the instruction from one of the two raters randomly chosen by the random number generator software from GraphPad. Both therapists will be rating all three activities of the CAS on their own rating paper. The two raters will be blinded to each other's ratings until end of study, and hence not allowed to discuss their ratings before all participants has been assessed. A third person, not otherwise involved in scoring of patients, will collect, and hold the scoring cards directly after the ratings.

Furthermore, age, gender, premorbid disability level (premorbid Modified Rankin scale), height, weight, stroke severity (National Institute of Health - Stroke Scale, Scandinavian Stroke Scale), lesion type and localization will be collected of each stroke victim at baseline. Data from CAS at other timepoints, handgrip strength and 30 second sit-to-stand test will also be collected.

Conditions
Stroke
Keywords
Reliability, Cumulated Ambulation Score, Stroke, Inter-rater reliability, Inter-tester reliability
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2022
  2. Study start24 Oct 2022
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05601089
Sponsor's protocol ID
P-2022-518
Status last verified
Sep 2023
First submitted
23 Oct 2022
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38325673

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