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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521234
• Other study ID #: OSN-Mansfield-2011
• Status: Completed
• Phase: N/A
• First received: January 23, 2012
• Last updated: May 11, 2015
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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 Control — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)	No
Primary	Change in control of walking	Self-selected walking speed and symmetry of spatio-temporal characteristics of walking	Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)	No
Secondary	Change in self-efficacy	Stroke self-efficacy questionnaire	Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)	No
Secondary	Goal attainment	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)	No
Secondary	Community integration	Community integration questionnaire	Discharge from out-patient rehabilitation (10-16 weeks) and 3-month follow-up	No
Secondary	Satisfaction with progress towards rehabilitation goals	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)	No
Secondary	Barriers to walking	Open-ended question regarding participants' perceived barriers to walking.	Monitored throughout participants' enrolment (0-28 weeks)	No
Secondary	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.	Monitored throughout participants' enrolment (0-28 weeks)	Yes