NCT04044911

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2014

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 7, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

July 5, 2019

Last Update Submit

August 5, 2019

Conditions

Keywords

Activity of daily livingStrokeApraxiaAction of daily livingCup of tea

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Tea making accuracy at follow-up

    2 assessments over 15 weeks

  • Change in complex tea making accuracy

    3 assessments over 12 weeks

Study Arms (2)

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.

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)

Behavioral: Task model (CogWatch)

Interventions

Stepping followed by tea makingTea making followed by stepping

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

StrokeApraxias

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPsychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alan M WIng, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover randomized control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2019

First Posted

August 5, 2019

Study Start

June 1, 2014

Primary Completion

December 4, 2014

Study Completion

December 4, 2014

Last Updated

August 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share