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

Randomised Controlled Trial of a Task Model Approach (CogWatch) to Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Apraxias
• Intervention / Treatment: Behavioral: Task model (CogWatch)

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Tea making followed by stepping; 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.	Behavioral: Task model (CogWatch)
ACTIVE_COMPARATOR: Stepping followed by tea making; 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)	Behavioral: Task model (CogWatch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 assessments over 12 weeks
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.	3 assessments over 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 assessments over 15 weeks
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.	3 assessments over 12 weeks

Collaborators and Investigators

• Sponsor: University of Birmingham
• Investigators: Principal Investigator: Alan M WIng, PhD, Professor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): December 4, 2014
• Study Completion (ACTUAL): December 4, 2014

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (ACTUAL): August 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Apraxia; Activity of daily living; Action of daily living; Cup of tea
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Psychomotor Disorders; Stroke; Apraxias
• Other Study ID Numbers: ERN_12-0683B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No