Tele-Rehabilitation Study for People With a History of Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724813
• Other study ID #: REB#15-37
• Status: Completed
• Phase: N/A
• First received: February 9, 2016
• Last updated: February 22, 2018
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Cognitive Orientation to Occupational Preformance (COOP)

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Baycrest	Health and Stroke Foundation-Canadian Partnership for Stroke recovery

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Canadian Occupational Performance Measure (COPM)	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
Primary	Changes in Reintegration to Normal Living Index (RNL)	The RNL is a measure of satisfaction with participation in everyday life	10 weeks and 14 weeks