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CompletedNCT05601089Updated Sep 6, 2023

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

An observational study in Stroke, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by University Hospital Bispebjerg and Frederiksberg · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Stroke

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Keywords

  • Reliability
  • Cumulated Ambulation Score
  • Stroke
  • Inter-rater reliability
  • Inter-tester reliability
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 60 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital Bispebjerg and Frederiksberg is the lead sponsor of 68 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not able to give informed consent
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
06

What researchers measure

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)

    Time frame: 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

07

Study locations

1 site
  • Department of Physio- and Occupational Therapy
    Bispebjerg, Copenhagen 2400, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05601089
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Collaborators
University College Copenhagen
Responsible party
Christian Hedelund Arens (Physiotherapist, MSc, University Hospital Bispebjerg and Frederiksberg) — Principal investigator
First posted
Nov 1, 2022
Start date
Oct 24, 2022
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Sep 6, 2023

Study contacts

Morten T. Kristensen, professor
study director · Department of Physio- and Occupational Therapy, Copenhagen University Hospital, Bispebjerg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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