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Trial Using CogWatch for Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome (CogWatchTea)

Primary Purpose

Stroke, Apraxias

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Task model (CogWatch)
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Activity of daily living, Stroke, Apraxia, Action of daily living, Cup of tea

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • greater than 2 months post stroke; medically stable; failing at least one of four praxis items in the Birmingham Cognitive Screen (BCoS) or a document filing task.

Exclusion Criteria:

  • recent stroke (less than 2 months post stroke); not medically stable

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Tea making followed by stepping

    Stepping followed by tea making

    Arm Description

    Five 1-hour weekly tea making training sessions in which progress is monitored and feedback given using a computer-based system that implements a Markov Decision Process (MDP) task model (CogWatch) is followed after a 3-week break by a control condition in which participants receive five 1-hour weekly stepping training sessions.

    A control condition comprising five 1-hour weekly stepping training sessions is followed after a 3-week break by five 1-hour weekly tea making training sessions in which progress is monitored and feedback given using a computer-based system that implements a Markov Decision Process (MDP) task model (COgWatch)

    Outcomes

    Primary Outcome Measures

    Change in tea making accuracy
    In three assessment sessions (initial, post-phase 1 training, post-phase 2 training), participants are seated at a table with objects and ingredients required for making a cup of tea placed in standard positions. Participants are instructed to make 8 cups of tea, one at a time, comprising two of each of the following; black tea, black tea with sugar, tea with milk and tea with milk and sugar. Each trial is recorded with a video camera. Videos of the participants making simple tea are analysed by a researcher blinded to the session definition. The summed errors across the 8 tea making trials at each assessment are used to provide a measure of accuracy for each participant. Change in tea making accuracy pre- and post-training of tea making is contrasted with change in tea making accuracy pre- and post-training of stepping.
    Change in tea making speed
    In three assessment sessions (initial, post-phase 1 training, post-phase 2 training), participants are seated at a table with objects and ingredients required for making a cup of tea placed in standard positions. Participants are instructed to make 8 cups of tea, one at a time, comprising two of each of the following; black tea, black tea with sugar, tea with milk and tea with milk and sugar. Each trial is recorded with a video camera. Videos of the participants making simple tea are analysed by a researcher blinded to the session definition. The average completion time is used as a measure of speed for each participant. Change in tea making speed pre- and post-training of tea making is contrasted with change in tea making speed pre- and post-training of stepping.

    Secondary Outcome Measures

    Tea making accuracy at follow-up
    In a fourth, follow-up assessment session (7 or 15 weeks post-tea making training), participants are seated at a table with objects and ingredients required for making a cup of tea placed in standard positions. Participants are instructed to make 8 cups of tea, one at a time, comprising two of each of the following; black tea, black tea with sugar, tea with milk and tea with milk and sugar. Each trial is recorded with a video camera. Videos of the participants making simple tea are analysed by a researcher blinded to the session definition. The summed errors across the 8 tea making trials at each assessment are used to provide a measure of accuracy for each participant. Tea making accuracy at follow-up is compared with tea making accuracy post-training of tea making.
    Change in complex tea making accuracy
    In three assessment sessions (initial, post-phase 1 training, post-phase 2 training), participants are seated at a table with objects and ingredients required for making two cups of tea placed in standard positions. Participants are instructed to make 4 cups of tea, two at a time, comprising one cup with tea, lemon and 1 sugar cube and the other with tea, milk and 2 sweeteners. Each trial is recorded with a video camera. Videos of the participants making complex tea are analysed by a researcher blinded to the session definition. The summed errors across the 4 tea making trials at each assessment are used to provide a measure of accuracy for each participant. Change in complex tea making accuracy pre- and post-training of tea making is contrasted with change in complex tea making accuracy pre- and post-training of stepping.

    Full Information

    First Posted
    July 5, 2019
    Last Updated
    August 5, 2019
    Sponsor
    University of Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04044911
    Brief Title
    Trial Using CogWatch for Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome
    Acronym
    CogWatchTea
    Official Title
    Randomised Controlled Trial of a Task Model Approach (CogWatch) to Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    December 4, 2014 (Actual)
    Study Completion Date
    December 4, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Apraxia and action disorganization syndrome after stroke can disrupt activities of daily living (ADL). Occupational therapy has been effective in improving ADL performance, however, inclusion of multiple tasks means it is unclear which therapy elements contribute to improvement. This study evaluates the efficacy of a task model approach to ADL rehabilitation, comparing training in making a cup of tea with a gait training control condition.
    Detailed Description
    Apraxia and action disorganization syndrome (AADS) after stroke can disrupt activities of daily living (ADLs). Occupational therapy has been effective in improving ADL performance, however, inclusion of multiple tasks means it is unclear which therapy elements contribute to improvement. This trial evaluates the efficacy of a task model approach to ADL rehabilitation, comparing training in making a cup of tea with a stepping training control condition. Stroke survivors with AADS participate in a cross-over randomized controlled study. Participants attend five 1-hour tea making training sessions in which progress is monitored and feedback given using a computer-based system which implements a Markov Decision Process (MDP) task model (CogWatch). In a control condition participants receive five 1-hour stepping sessions. Analysis compares tea making training with stepping training effects on error reduction and time taken in making 4 different tea types. A complex tea preparation task (making two different cups of tea simultaneously) is used to test for generalisation of training effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Apraxias
    Keywords
    Activity of daily living, Stroke, Apraxia, Action of daily living, Cup of tea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Crossover randomized control
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tea making followed by stepping
    Arm Type
    Active Comparator
    Arm Description
    Five 1-hour weekly tea making training sessions in which progress is monitored and feedback given using a computer-based system that implements a Markov Decision Process (MDP) task model (CogWatch) is followed after a 3-week break by a control condition in which participants receive five 1-hour weekly stepping training sessions.
    Arm Title
    Stepping followed by tea making
    Arm Type
    Active Comparator
    Arm Description
    A control condition comprising five 1-hour weekly stepping training sessions is followed after a 3-week break by five 1-hour weekly tea making training sessions in which progress is monitored and feedback given using a computer-based system that implements a Markov Decision Process (MDP) task model (COgWatch)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Task model (CogWatch)
    Primary Outcome Measure Information:
    Title
    Change in tea making accuracy
    Description
    In three assessment sessions (initial, post-phase 1 training, post-phase 2 training), participants are seated at a table with objects and ingredients required for making a cup of tea placed in standard positions. Participants are instructed to make 8 cups of tea, one at a time, comprising two of each of the following; black tea, black tea with sugar, tea with milk and tea with milk and sugar. Each trial is recorded with a video camera. Videos of the participants making simple tea are analysed by a researcher blinded to the session definition. The summed errors across the 8 tea making trials at each assessment are used to provide a measure of accuracy for each participant. Change in tea making accuracy pre- and post-training of tea making is contrasted with change in tea making accuracy pre- and post-training of stepping.
    Time Frame
    3 assessments over 12 weeks
    Title
    Change in tea making speed
    Description
    In three assessment sessions (initial, post-phase 1 training, post-phase 2 training), participants are seated at a table with objects and ingredients required for making a cup of tea placed in standard positions. Participants are instructed to make 8 cups of tea, one at a time, comprising two of each of the following; black tea, black tea with sugar, tea with milk and tea with milk and sugar. Each trial is recorded with a video camera. Videos of the participants making simple tea are analysed by a researcher blinded to the session definition. The average completion time is used as a measure of speed for each participant. Change in tea making speed pre- and post-training of tea making is contrasted with change in tea making speed pre- and post-training of stepping.
    Time Frame
    3 assessments over 12 weeks
    Secondary Outcome Measure Information:
    Title
    Tea making accuracy at follow-up
    Description
    In a fourth, follow-up assessment session (7 or 15 weeks post-tea making training), participants are seated at a table with objects and ingredients required for making a cup of tea placed in standard positions. Participants are instructed to make 8 cups of tea, one at a time, comprising two of each of the following; black tea, black tea with sugar, tea with milk and tea with milk and sugar. Each trial is recorded with a video camera. Videos of the participants making simple tea are analysed by a researcher blinded to the session definition. The summed errors across the 8 tea making trials at each assessment are used to provide a measure of accuracy for each participant. Tea making accuracy at follow-up is compared with tea making accuracy post-training of tea making.
    Time Frame
    2 assessments over 15 weeks
    Title
    Change in complex tea making accuracy
    Description
    In three assessment sessions (initial, post-phase 1 training, post-phase 2 training), participants are seated at a table with objects and ingredients required for making two cups of tea placed in standard positions. Participants are instructed to make 4 cups of tea, two at a time, comprising one cup with tea, lemon and 1 sugar cube and the other with tea, milk and 2 sweeteners. Each trial is recorded with a video camera. Videos of the participants making complex tea are analysed by a researcher blinded to the session definition. The summed errors across the 4 tea making trials at each assessment are used to provide a measure of accuracy for each participant. Change in complex tea making accuracy pre- and post-training of tea making is contrasted with change in complex tea making accuracy pre- and post-training of stepping.
    Time Frame
    3 assessments over 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: greater than 2 months post stroke; medically stable; failing at least one of four praxis items in the Birmingham Cognitive Screen (BCoS) or a document filing task. Exclusion Criteria: recent stroke (less than 2 months post stroke); not medically stable
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alan M WIng, PhD
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35239707
    Citation
    Howe J, Chua W, Sumner E, Drozdowska B, Laverick R, Bevins RL, Jean-Baptiste E, Russell M, Rotshtein P, Wing AM. The efficacy of a task model approach to ADL rehabilitation in stroke apraxia and action disorganisation syndrome: A randomised controlled trial. PLoS One. 2022 Mar 3;17(3):e0264678. doi: 10.1371/journal.pone.0264678. eCollection 2022.
    Results Reference
    derived

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    Trial Using CogWatch for Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome

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