Validations of the Computerized Adaptive Testing System of the Functional Assessment of Stroke

NCT05524818 | Completed

• 1 other identifier: IRB109-176-B
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Purposes: The aim of this study is to preliminarily validate the test-retest reliability, random measurement error, practice effect, and responsiveness of the the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) in real clinical settings. Methods: Patients in both chronic (get stroke over 6 months) and sub-acute (get stroke less than 6 months) stages will be recruited. These patients will be classified into "test-retest reliability group" and "responsiveness group" to examine the test-retest reliability and responsiveness of the CAT-FAS, respectively. All participants will receive the administrations of CAT-FAS twice. For those in the test-retest reliability group, the administrations will be performed with a 4-week interval. For those in the responsiveness group, the administrations will be performed at admitting to the rehabilitation unit and before they are discharged.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)

  The Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) comprises 58 items. The items were selected from four well-known physical function measures for patients with stroke: 26 items from the Fugl-Meyer Assessment-Upper Limb, 11 items from the Fugl-Meyer Assessment-Lower Limb, 12 items from the Postural Assessment Scale for Stroke Patients, and 9 items from the Barthel Index. Results are automatically reported as Rasch scores (i.e., the minimum and maximum values are negative and positive infinity, respectively). A higher score indicates greater physical functions.

  4 weeks.

Study Arms (2)

Test-retest reliability group

All the participants received conventional rehabilitation (e.g., occupational therapy, physical therapy, or speech therapy) or other interventions (e.g., acupuncture) as usual during the research period.

Diagnostic Test: the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)

Responsiveness group

All the participants received conventional rehabilitation (e.g., occupational therapy, physical therapy, or speech therapy) or other interventions (e.g., acupuncture) as usual during the research period.

Diagnostic Test: the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS)

Interventions

the Computerized Adaptive Testing System of the Functional Assessment of Stroke (CAT-FAS) DIAGNOSTIC_TEST

The CAT-FAS comprises 58 items. The items were selected from four well-known physical function measures for patients with stroke: 26 items from the Fugl-Meyer Assessment-Upper Limb, 11 items from the Fugl-Meyer Assessment-Lower Limb, 12 items from the Postural Assessment Scale for Stroke Patients, and 9 items from the Barthel Index. These items evaluate motor control, postural control, and activity of daily living functions in patients with stroke. The CAT-FAS assesses all these functions simultaneously. Results are automatically reported as Rasch scores. A higher score indicates greater physical functions. In the previous study, results indicated that the CAT-FAS had sufficient efficiency (\< 10 items on average), reliability (Rasch reliability ≥ 0.88), concurrent validity (Pearson r ≥ 0.91), and responsiveness (SRM ≥ 0.65) in persons with stroke.

Responsiveness group; Test-retest reliability group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Persons with stroke were recruited from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan using consecutive sampling.

You may qualify if:

• Cerebral hemorrhage or cerebral infarction.
• Age ≥ 20 years.
• Stroke onset ≥ 6 months (first and recurrent stroke included).
• Ability to follow 3-step verbal instructions.
• Cerebral hemorrhage or cerebral infarction.
• Age ≥ 20 years.
• Stroke onset \< 3 months (first and recurrent stroke included).
• Ability to follow 3-step verbal instructions.

You may not qualify if:

• Cannot complete the Computerized Adaptive Testing System of the Functional Assessment of Stroke twice.
• Refuse to provide informed consent.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Hualien County, 970, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: April 14, 2021
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-08

Locations

TW (1)