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

This study is currently recruiting participants.
Verified February 2013 by Toronto Rehabilitation Institute
Sponsor:
Information provided by (Responsible Party):
Avril Mansfield, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01521234
First received: January 23, 2012
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Stroke
 Behavioral: Feedback of daily walking activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Wireless Technology in Clinical Practice: Does Feedback of Daily Walking Activity Improve Walking Outcomes of Individuals Receiving Rehabilitation Post-stroke?

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Change in walking activity from admission to discharge from rehabilitation [ Time Frame: Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Self-selected walking speed and symmetry of spatio-temporal characteristics of walking


Secondary Outcome Measures:
  • Change in self-efficacy [ Time Frame: Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks) ] [ Designated as safety issue: No ]
    Stroke self-efficacy questionnaire

  • Goal attainment [ Time Frame: Discharge from in-patient rehabilitation (4-6 weeks), discharge from out-patient rehabilitation (10-16 weeks) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Open-ended question regarding participants' perceived barriers to walking.

  • Falls [ Time Frame: Monitored throughout participants' enrolment (0-28 weeks) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 78
Study Start Date: October 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521234

Contacts
Contact: Avril Mansfield, PhD 416-597-3422 ext 7831 avril.mansfield@uhn.ca

Locations
Canada, Ontario
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M5G 2A2
Contact: Avril Mansfield, PhD     416-597-3422 ext 7831     avril.mansfield@uhn.ca    
Sponsors and Collaborators
Toronto Rehabilitation Institute
Investigators
Principal Investigator: Avril Mansfield, PhD Toronto Rehabilitation Institute
  More Information

Publications:

Responsible Party: Avril Mansfield, Post-doctoral fellow, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01521234     History of Changes
Other Study ID Numbers: OSN-Mansfield-2011
Study First Received: January 23, 2012
Last Updated: February 4, 2013
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

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

ClinicalTrials.gov processed this record on May 23, 2013