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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Feedback of daily walking activity
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Feedback group

No-feedback group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in walking activity from admission to discharge from rehabilitation
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
Self-selected walking speed and symmetry of spatio-temporal characteristics of walking

Secondary Outcome Measures

Change in self-efficacy
Stroke self-efficacy questionnaire
Goal attainment
Rehabilitation goals are classified as 'achieved', 'partially achieved', 'not completed' or 'discontinued'.
Community integration
Community integration questionnaire
Satisfaction with progress towards rehabilitation goals
Participants will be asked to rate satisfaction with progress towards goals on a 10-point scale
Barriers to walking
Open-ended question regarding participants' perceived barriers to walking.
Falls
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.

Full Information

First Posted
January 23, 2012
Last Updated
May 11, 2015
Sponsor
Toronto Rehabilitation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01521234
Brief Title
Using Wireless-technology for Feedback of Daily Walking Activity Post-stroke
Official Title
Using Wireless Technology in Clinical Practice: Does Feedback of Daily Walking Activity Improve Walking Outcomes of Individuals Receiving Rehabilitation Post-stroke?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback group
Arm Type
Experimental
Arm Description
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.
Arm Title
No-feedback group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Feedback of daily walking activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in walking activity from admission to discharge from rehabilitation
Description
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).
Time Frame
Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)
Title
Change in control of walking
Description
Self-selected walking speed and symmetry of spatio-temporal characteristics of walking
Time Frame
Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)
Secondary Outcome Measure Information:
Title
Change in self-efficacy
Description
Stroke self-efficacy questionnaire
Time Frame
Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)
Title
Goal attainment
Description
Rehabilitation goals are classified as 'achieved', 'partially achieved', 'not completed' or 'discontinued'.
Time Frame
Discharge from in-patient rehabilitation (4-6 weeks), discharge from out-patient rehabilitation (10-16 weeks)
Title
Community integration
Description
Community integration questionnaire
Time Frame
Discharge from out-patient rehabilitation (10-16 weeks) and 3-month follow-up
Title
Satisfaction with progress towards rehabilitation goals
Description
Participants will be asked to rate satisfaction with progress towards goals on a 10-point scale
Time Frame
Discharge from in-patient rehabilitation (4-6 weeks) and discharge from out-patient rehabilitation (10-16 weeks)
Title
Barriers to walking
Description
Open-ended question regarding participants' perceived barriers to walking.
Time Frame
Monitored throughout participants' enrolment (0-28 weeks)
Title
Falls
Description
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.
Time Frame
Monitored throughout participants' enrolment (0-28 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avril Mansfield, PhD
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20829413
Citation
Prajapati SK, Gage WH, Brooks D, Black SE, McIlroy WE. A novel approach to ambulatory monitoring: investigation into the quantity and control of everyday walking in patients with subacute stroke. Neurorehabil Neural Repair. 2011 Jan;25(1):6-14. doi: 10.1177/1545968310374189. Epub 2010 Sep 9.
Results Reference
background
PubMed Identifier
23865593
Citation
Mansfield A, Wong JS, Bayley M, Biasin L, Brooks D, Brunton K, Howe JA, Inness EL, Jones S, Lymburner J, Mileris R, McIlroy WE. Using wireless technology in clinical practice: does feedback of daily walking activity improve walking outcomes of individuals receiving rehabilitation post-stroke? Study protocol for a randomized controlled trial. BMC Neurol. 2013 Jul 18;13:93. doi: 10.1186/1471-2377-13-93.
Results Reference
background
PubMed Identifier
25605632
Citation
Mansfield A, Wong JS, Bryce J, Brunton K, Inness EL, Knorr S, Jones S, Taati B, McIlroy WE. Use of Accelerometer-Based Feedback of Walking Activity for Appraising Progress With Walking-Related Goals in Inpatient Stroke Rehabilitation: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Oct;29(9):847-57. doi: 10.1177/1545968314567968. Epub 2015 Jan 20.
Results Reference
result

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

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