StrokeCogWatchTeaNCT04044911
Trial Using CogWatch for Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome
A study testing Task model (CogWatch) in people with Stroke and Apraxias, run by University of Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Task model (CogWatch)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 4 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- recent stroke (less than 2 months post stroke); not medically stable
About this study
Official title: 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.
Read the 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.
- Being tested
- Task model (CogWatch)
- Keywords
- Activity of daily living, Stroke, Apraxia, Action of daily living, Cup of tea
- Medical subject headings
- Stroke, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task model (CogWatch)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Tea making followed by stepping | Active comparator | 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. Receives: Behavioral: Task model (CogWatch) |
| Stepping followed by tea making | Active comparator | 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) Receives: Behavioral: Task model (CogWatch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 assessments over 12 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 assessments over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Jun 2014
- Primary completion4 Dec 2014
- Study completion4 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover randomized control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan M WIng, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044911
- Sponsor's protocol ID
- ERN_12-0683B
- Acronym
- CogWatchTea
- Status last verified
- Mar 2019
- First submitted
- 5 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35239707
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of a Task Model Approach (CogWatch) to Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome
- ClinicalTrials.gov ID
- NCT04044911
- Acronym / sponsor ID
- CogWatchTea / ERN_12-0683B
- Keywords
- Activity of daily living, Stroke, Apraxia, Action of daily living, Cup of tea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 4 Dec 2014 (actual)
- Study completion
- 4 Dec 2014 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover randomized control
| Arm | Type | Receives |
|---|---|---|
| Tea making followed by stepping | Active comparator | Behavioral: Task model (CogWatch)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. |
| Stepping followed by tea making | Active comparator | Behavioral: Task model (CogWatch)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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- recent stroke (less than 2 months post stroke); not medically stable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task model (CogWatch) | Behavioural | Stepping followed by tea making, Tea making followed by stepping |
Primary outcome
Change in tea making accuracy
Time frame: 3 assessments over 12 weeks
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
Time frame: 3 assessments over 12 weeks
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.
2 secondary outcomes
Tea making accuracy at follow-up
Time frame: 2 assessments over 15 weeks
Change in complex tea making accuracy
Time frame: 3 assessments over 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 35239707Howe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan M WIng, PhD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing Task model (CogWatch) in people with Stroke and Apraxias, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tea making accuracy (time frame: 3 assessments over 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.