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

May 11, 2015 updated by: Avril Mansfield, Toronto Rehabilitation Institute

Using Wireless Technology in Clinical Practice: Does Feedback of Daily Walking Activity Improve Walking Outcomes of Individuals Receiving Rehabilitation Post-stroke?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2A2
        • Toronto Rehabilitation Institute

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)
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
Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-efficacy
Time Frame: Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)
Stroke self-efficacy questionnaire
Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)
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'.
Discharge from in-patient rehabilitation (4-6 weeks), discharge from out-patient rehabilitation (10-16 weeks)
Community integration
Time Frame: Discharge from out-patient rehabilitation (10-16 weeks) and 3-month follow-up
Community integration questionnaire
Discharge from out-patient rehabilitation (10-16 weeks) and 3-month follow-up
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
Discharge from in-patient rehabilitation (4-6 weeks) and discharge from out-patient rehabilitation (10-16 weeks)
Barriers to walking
Time Frame: Monitored throughout participants' enrolment (0-28 weeks)
Open-ended question regarding participants' perceived barriers to walking.
Monitored throughout participants' enrolment (0-28 weeks)
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.
Monitored throughout participants' enrolment (0-28 weeks)

Collaborators and Investigators

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

Sponsor

Toronto Rehabilitation Institute

Investigators

  • Principal Investigator: Avril Mansfield, PhD, Toronto Rehabilitation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSN-Mansfield-2011

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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