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Tele-Rehabilitation Study for People With a History of Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02724813
First Posted: March 31, 2016
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Health and Stroke Foundation-Canadian Partnership for Stroke recovery
Information provided by (Responsible Party):
Dr. Deirdre Dawson, Baycrest
February 9, 2016
March 31, 2016
November 9, 2017
November 2015
September 30, 2017   (Final data collection date for primary outcome measure)
  • 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
  • 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
Same as current
Complete list of historical versions of study NCT02724813 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Tele-Rehabilitation Study for People With a History of Stroke
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Behavioral: Cognitive Orientation to Occupational Preformance (COOP)
  • 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™.
    Intervention: 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™.
    Intervention: Behavioral: Cognitive Orientation to Occupational Preformance (COOP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
December 2017
September 30, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT02724813
REB#15-37
No
Not Provided
Plan to Share IPD: No
Dr. Deirdre Dawson, Baycrest
Baycrest
Health and Stroke Foundation-Canadian Partnership for Stroke recovery
Principal Investigator: Deirdre Dawson, PhD Baycrest Health Sciences
Baycrest
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP