Tele-Rehabilitation Study for People With a History of Stroke

February 22, 2018 updated by: Dr. Deirdre Dawson, Baycrest

Tele-rehabilitation for Cognitive Disability Post Stroke: Enhancing Function in the Face of Geographical Disparities

Stroke results in long-term disability for many people, and particularly for survivors of stroke who have cognitive impairments. However, a decreasing proportion of stroke patients are able to access or receive publicly funded rehabilitation. The investigators have shown in previous studies that in-person delivery of the Cognitive Orientation to daily Occupational Performance (CO-OP) rehabilitation approach to promoting attainment of everyday life goals has resulted in improvements in functional independence and executive function. In a small pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI) (n=3), the investigators found the delivery method was feasible and that participants were satisfied with the treatment and demonstrated clinically significant improvements on personally meaningful activities. The investigators will investigate the feasibility, preliminary efficacy, and cost-effectiveness of delivering CO-OP in an online format to reduce disability post-stroke. The study design is a single-blind (assessor), randomized wait-list control trial with a one-month retention follow-up. All therapy and testing sessions will be delivered online. We hypothesize that participants will demonstrate improvement in everyday activities and community participation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

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, M6A 2E1
        • Baycrest Health Sciences

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community-dwelling adults at least three months post-stroke
  • Fluent in written and spoken English
  • Impairment of executive cognitive functions
  • Ability to self-identify specific areas of difficulty in their everyday life that they would like to improve
  • Access to a computer or tablet with a high-speed internet connection

Exclusion Criteria:

  • Presence of dementia
  • Severe concurrent depression
  • Severe aphasia
  • Concurrent substance abuse

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Participants will receive 16 one-hour tele-CO-OP sessions delivered over a 10-week period by a licensed health care professional. We will deliver tele-CO-OP via Skype™ and record all sessions using Pamela software for Skype™.
Behavioral: Cognitive Orientation to Occupational Preformance (COOP)
Active Comparator: Wait-list arm
Participant in this arm will receive therapy 8 weeks after initial assessment. Participants will receive 16 one-hour tele-CO-OP sessions delivered over a 10-week period by a licensed health care professional. We will deliver tele-CO-OP via Skype™ and record all sessions using Pamela software for Skype™.
Behavioral: Cognitive Orientation to Occupational Preformance (COOP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Canadian Occupational Performance Measure (COPM)
Time Frame: 10 weeks and 14 weeks
The COPM is a standardized, semi-structured interview that facilitates goal identification and has been used as the primary outcome measure for many of the CO-OP studies
10 weeks and 14 weeks
Changes in Reintegration to Normal Living Index (RNL)
Time Frame: 10 weeks and 14 weeks
The RNL is a measure of satisfaction with participation in everyday life
10 weeks and 14 weeks

Collaborators and Investigators

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

Sponsor

Baycrest

Collaborators

Health and Stroke Foundation-Canadian Partnership for Stroke recovery

Investigators

  • Principal Investigator: Deirdre Dawson, PhD, Baycrest Health Sciences

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

November 1, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB#15-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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