NCT01521234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

January 23, 2012

Last Update Submit

May 11, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (6)

  • Change in self-efficacy

    Admission and discharge from in-patient rehabilitation (approx. 4-6 weeks)

  • Goal attainment

    Discharge from in-patient rehabilitation (4-6 weeks), discharge from out-patient rehabilitation (10-16 weeks)

  • Community integration

    Discharge from out-patient rehabilitation (10-16 weeks) and 3-month follow-up

  • Satisfaction with progress towards rehabilitation goals

    Discharge from in-patient rehabilitation (4-6 weeks) and discharge from out-patient rehabilitation (10-16 weeks)

  • Barriers to walking

    Monitored throughout participants' enrolment (0-28 weeks)

  • +1 more secondary outcomes

Study Arms (2)

Feedback group

EXPERIMENTAL

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

No-feedback group

NO INTERVENTION

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.

Interventions

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.

Feedback group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

Related Publications (3)

  • 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.

    PMID: 20829413BACKGROUND
  • 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.

    PMID: 23865593BACKGROUND
  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Avril Mansfield, PhD

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral fellow

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 30, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations