Clinical trial NCT00849446: Validity and Reliability of an Activity Monitor in Persons With a Cerebrovascular Accident
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accident
Lead sponsor: University College of Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2009-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.

Brief summary: Background:Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.

Purpose: The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.

Patients and Methods Subjects: Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.

Methods: During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.

Measures:Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.

Detailed description: Evaluation of the SenseWear Pro Armband to assess physical activity in individuals with chronic stroke

Background:

Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.

Purpose:

The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.

Patients and Methods Subjects Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.

Methods During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.

Measures:

Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.

Eligibility criteria: Inclusion criteria:

* an ischemic or hemorrhagic stroke
* stroke onset less than 3 months
* score 3 or more Functional Ambulation Categories
* age \< 80 years
* ability to cycle independently
* written authorisation on the informed consent

Exclusion criteria:

* serious other diseases which might have an influence on carrying out the standardised activities
* cannot understand and carry out simple instructions

Primary outcomes:
measure: Total energy expenditure (kcal)during selected physical activities
timeFrame: measurement at 1 time point
Secondary outcomes:
measure: Number of steps
timeFrame: measurement at 1 time point
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital of Antwerp
state: Antwerp
Study officials:
References: