Psychometric Evaluation of Commonly Used Measures in Stroke

NCT05530525 | Completed

• 1 other identifier: IRB110-263-B
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Purposes: The aim of this study is to examine the psychometric properties (e.g. test-retest reliability, random measurement error, practice effect, and responsiveness) of the commonly used measures in patients with stroke using medical record review. The investigators anticipate reviewing 1000 stroke patients' medical record from a medical center in Taiwan. The medical record will be reviewed by an experienced and well-trained occupational therapist.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• The computerized adaptive testing system of the functional assessment of stroke

  The Computerized Adaptive Testing system of the Functional Assessment of Stroke 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. 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.

  The repeated assessments were performed at an one-month interval.

• The Barthel Index

  The Barthel Index has 10 items, and the total score ranges from 0 to 100. Higher score indicates less disability on activity of daily living functions.

  The repeated assessments were performed at an one-month interval.

• The National Institutes of Health Stroke Scale

  The National Institutes of Health Stroke Scale comprises 11 items and was used to monitor the severity in the patients with stroke. The total score ranges from 0 to 42, with a higher score indicating greater severity. A National Institutes of Health Stroke Scale score of 1-5 indicates mild severity; 6-14, mild to moderate severity; 15-24, severe severity; and equal to or greater than 25, very severe severity.

  The repeated assessments were performed at an one-month interval.

Study Arms (1)

Test-retest reliability and responsiveness group (All of the data was collected from medical record)

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

Diagnostic Test: The Computerized Adaptive Testing system of the Functional Assessment of Stroke; Diagnostic Test: The Barthel Index; Diagnostic Test: The National Institutes of Health Stroke Scale

Interventions

The Computerized Adaptive Testing system of the Functional Assessment of Stroke DIAGNOSTIC_TEST

The Computerized Adaptive Testing system of the Functional Assessment of Stroke 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. 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.

Test-retest reliability and responsiveness group (All of the data was collected from medical record)

The Barthel Index DIAGNOSTIC_TEST

The Barthel Index has 10 items, and the total score ranges from 0 to 100. Higher score indicates less disability on activity of daily living functions.

Test-retest reliability and responsiveness group (All of the data was collected from medical record)

The National Institutes of Health Stroke Scale DIAGNOSTIC_TEST

The National Institutes of Health Stroke Scale comprises 11 items and was used to monitor the severity in the patients with stroke. The total score ranges from 0 to 42, with a higher score indicating greater severity. A National Institutes of Health Stroke Scale score of 1-5 indicates mild severity; 6-14, mild to moderate severity; 15-24, severe severity; and equal to or greater than 25, very severe severity.

Test-retest reliability and responsiveness group (All of the data was collected from medical record)

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

All the data was from the medical record (from 2018/6/1 to 2021/6/30) from the Department of Physical Medicine and Rehabilitation at a medical center in Taiwan.

You may qualify if:

• Cerebral hemorrhage or cerebral infarction.
• Age ≥ 20 years.
• Stroke onset ≥ 6 months (first and recurrent stroke included).
• Cerebral hemorrhage or cerebral infarction.
• Age ≥ 20 years.
• Stroke onset \< 3 months (first and recurrent stroke included).

You may not qualify if:

• Patients' diagnosis is not stroke.

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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 7, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2025

Record last verified: 2022-08

Locations

TW (1)