Tele-Rehabilitation Study for People With a History of Stroke

NCT ID: NCT02724813

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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™.

Group Type EXPERIMENTAL

Cognitive Orientation to Occupational Preformance (COOP)

Intervention Type BEHAVIORAL

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™.

Group Type ACTIVE_COMPARATOR

Cognitive Orientation to Occupational Preformance (COOP)

Intervention Type BEHAVIORAL

Interventions

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Cognitive Orientation to Occupational Preformance (COOP)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health and Stroke Foundation-Canadian Partnership for Stroke recovery

UNKNOWN

Sponsor Role collaborator

Baycrest

OTHER

Sponsor Role lead

Responsible Party

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Dr. Deirdre Dawson

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deirdre Dawson, PhD

Role: PRINCIPAL_INVESTIGATOR

Baycrest Health Sciences

Locations

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Baycrest Health Sciences

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Dawson DR, Anderson ND, Binns M, Bar Y, Chui A, Gill N, Linkewich E, McEwen S, Nalder E, Skidmore E. Strategy-training post-stroke via tele-rehabilitation: a pilot randomized controlled trial. Disabil Rehabil. 2024 Jan;46(1):67-76. doi: 10.1080/09638288.2022.2154397. Epub 2022 Dec 14.

Reference Type DERIVED
PMID: 36524387 (View on PubMed)

Other Identifiers

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REB#15-37

Identifier Type: -

Identifier Source: org_study_id

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