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Using Wireless-technology for Feedback of Daily Walking Activity Post-stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521234
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Avril Mansfield, Toronto Rehabilitation Institute

Tracking Information
First Submitted Date  ICMJE January 23, 2012
First Posted Date  ICMJE January 30, 2012
Last Update Posted Date May 13, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • Change in walking activity from admission to discharge from rehabilitation [ Time Frame: Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks) ]
    Total daily walking acitivty, measured by number of steps per day, total duration of walking activity, total distance walked, and frequency of 'long' walking bouts (>5 minutes in duration).
  • Change in control of walking [ Time Frame: Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks) ]
    Self-selected walking speed and symmetry of spatio-temporal characteristics of walking
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01521234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • Change in self-efficacy [ Time Frame: Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks) ]
    Stroke self-efficacy questionnaire
  • Goal attainment [ Time Frame: Discharge from in-patient rehabilitation (4-6 weeks), discharge from out-patient rehabilitation (10-16 weeks) ]
    Rehabilitation goals are classified as 'achieved', 'partially achieved', 'not completed' or 'discontinued'.
  • Community integration [ Time Frame: Discharge from out-patient rehabilitation (10-16 weeks) and 3-month follow-up ]
    Community integration questionnaire
  • Satisfaction with progress towards rehabilitation goals [ Time Frame: Discharge from in-patient rehabilitation (4-6 weeks) and discharge from out-patient rehabilitation (10-16 weeks) ]
    Participants will be asked to rate satisfaction with progress towards goals on a 10-point scale
  • Barriers to walking [ Time Frame: Monitored throughout participants' enrolment (0-28 weeks) ]
    Open-ended question regarding participants' perceived barriers to walking.
  • Falls [ Time Frame: Monitored throughout participants' enrolment (0-28 weeks) ]
    Increased walking activity might increase the risk for falls. Falls experienced throughout the study will be recorded to determine if there are more falls in the experimental group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Wireless-technology for Feedback of Daily Walking Activity Post-stroke
Official Title  ICMJE Using Wireless Technology in Clinical Practice: Does Feedback of Daily Walking Activity Improve Walking Outcomes of Individuals Receiving Rehabilitation Post-stroke?
Brief Summary Regaining independent walking is the top priority for individuals recovering from stroke. Thus, physical rehabilitation post-stroke should focus on improving walking function and endurance. However, the amount of walking completed by individuals with stroke attending rehabilitation is far below that required for independent community ambulation. There has been increased interest in accelerometer-based monitoring of walking post-stroke. Walking monitoring could be integrated within the goal-setting process for those with ambulation goals in rehabilitation. The purpose of this study is to determine the effect of accelerometer-based feedback of daily walking activity during rehabilitation on the frequency and duration of walking post-stroke.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: Feedback of daily walking activity
Participants will wear accelerometers every weekday during in-patient rehabilitation to monitor walking activity. Feedback of daily walking activity will be provided to the patients' treating physiotherapists to assist with goal-planning around walking.
Study Arms  ICMJE
  • Experimental: Feedback group
    For participants assigned to the feedback group, physiotherapists will receive a summary of patients' walking activity for the previous week as a tool to guide goal planning. Physiotherapists will use the information as a 'homework checker' to determine if patients are complying with an assigned walking program. In the case of non-compliance, the physiotherapist will discuss a coping strategy for better integrating walking activity into the patients' day. In the event that the patient is meeting their specific sub-goals for walking activity, the physiotherapist will re-evaluate these sub-goals and suggest more challenging goals.
    Intervention: Behavioral: Feedback of daily walking activity
  • No Intervention: No-feedback group
    For participants assigned to the control group, physiotherapists will not receive accelerometer-based feedback of daily walking activity. However, physiotherapists will still discuss the achievement of walking goals with their patients. This is usual care around goal planning.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2015)
63
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2012)
78
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • individuals with sub-acute stroke attending in-patient rehabilitation at Toronto Rehab
  • patients who have identified improving walking function as a rehabilitation goal
  • patients who can walk without supervision at the time of recruitment into the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01521234
Other Study ID Numbers  ICMJE OSN-Mansfield-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avril Mansfield, Toronto Rehabilitation Institute
Study Sponsor  ICMJE Toronto Rehabilitation Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avril Mansfield, PhD Toronto Rehabilitation Institute
PRS Account Toronto Rehabilitation Institute
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP