Validity and Reliability of an Activity Monitor in Persons With a Cerebrovascular Accident

August 23, 2011 updated by: University College of Antwerp

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • University Hospital of Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Activity monitoring in CVA patients
Device: Activity monitor (SenseWear Pro armband)
Activity monitoring during specific physical activities such as walking at different speeds
Other Names:
  • Sensewear
Activity monitoring in healthy persons
Device: Activity monitor (SenseWear Pro armband)
Activity monitoring during specific physical activities such as walking at different speeds
Other Names:
  • Sensewear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total energy expenditure (kcal)during selected physical activities
Time Frame: measurement at 1 time point
measurement at 1 time point

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of steps
Time Frame: measurement at 1 time point
measurement at 1 time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College of Antwerp

Collaborators

Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (ESTIMATE)

February 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2011

Last Update Submitted That Met QC Criteria

August 23, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARTESIS-DepG-2009-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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