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

This study has been completed.
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
University College of Antwerp
ClinicalTrials.gov Identifier:
NCT00849446
First received: February 20, 2009
Last updated: August 23, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Cerebrovascular Accident
Device: Activity monitor (SenseWear Pro armband)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by University College of Antwerp:

Primary Outcome Measures:
  • Total energy expenditure (kcal)during selected physical activities [ Time Frame: measurement at 1 time point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of steps [ Time Frame: measurement at 1 time point ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Activity monitoring in CVA patients Device: Activity monitor (SenseWear Pro armband)
Activity monitoring during specific physical activities such as walking at different speeds
Other Name: 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 Name: Sensewear

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849446

Locations
Belgium
University Hospital of Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University College of Antwerp
Universiteit Antwerpen
  More Information

No publications provided

Responsible Party: University College of Antwerp
ClinicalTrials.gov Identifier: NCT00849446     History of Changes
Other Study ID Numbers: ARTESIS-DepG-2009-1
Study First Received: February 20, 2009
Last Updated: August 23, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014