Tablet-based Aphasia Therapy in the Acute Phase After Stroke

NCT03679637 | Completed

• 1 other identifier: EC/2018/1006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

As aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits, it is now thought that intensive aphasia therapy is effective, even in the chronic phase following stroke. However, as intensive aphasia rehabilitation is difficult to achieve in clinical practice, tablet-based aphasia therapies are explored to further facilitate language recovery. Although there is mounting evidence that computer-based treatments are effective, it is also important to assess the feasibility, usability and acceptability of these technologies, especially in the acute phase post stroke. The investigators assume that tablet-based aphasia therapy is a feasible treatment option for patients with aphasia in the acute phase following stroke. The researchers also believe that the specific app that will be used in therapy is user-friendly and that it will be well accepted by this specific patient population.

Conditions

Aphasia; Stroke, Acute

Outcome Measures

Primary Outcomes (8)

• Feasibility of a tablet-based aphasia therapy via the recruitment rate

  Recruitment rate: number of patients enrolled versus total patients meeting study criteria + notation of reasons why patients did not enroll

  from date of inclusion to date of hospital discharge, assessed up to 20 weeks

• Feasibility of a tablet-based aphasia therapy via the retention rate

  Retention rate: number of patients continuing to use the mobile tablet until the time of discharge + notation of reasons why patients did not continue practicing

  from date of inclusion to date of hospital discharge, assessed up to 20 weeks

• Feasibility of a tablet-based aphasia therapy via the adherence rate,

  Adherence rate: time patients practiced versus time advised to practice + notation of reasons why patients did not practice the advised time

  from date of inclusion to date of hospital discharge, assessed up to 20 weeks

• Feasibility of a tablet-based aphasia therapy via protocol deviations

  Notation of any protocol deviations

  from date of inclusion to date of hospital discharge, assessed up to 20 weeks

• Usability of a tablet-based aphasia therapy via a self-prepared usability questionnaire,

  Self-prepared usability questionnaire: patients will need to fill in a 5 question survey (5-point Likert scale) measuring the usability of a tablet-based therapy. Minimum score is 1 (= totally not agree), maximum score is 5 (= totally agree)

  date of hospital discharge, an average of 1 week

• Usability of a tablet-based aphasia therapy via an observational checklist

  Self-prepared observational checklist: patients will be observed during a therapy session. Different sub-tasks will be scored for independency on a 3-point scale. Minimum score is 1 (completely dependent), maximum score is 3 (= completely independent)

  date of hospital discharge, assessed up to 20 weeks

• Usability of a tablet-based aphasia therapy via within-task improvements of the app

  Notation of exercises performed with the app

  from date of inclusion to date of hospital discharge, assessed up to 20 weeks

• Acceptability of a tablet-based aphasia therapy via a vertical VAS-scale for satisfaction

  Vertical visual anologue scale (VAS) for satisfaction: patients have to indicate their general level of satisfaction post-intervention on a vertical VAS-scale. Minimum score is 0 (= not satisfied), maximum score is 100 (= very satisfied)

  date of hospital discharge, an average of 1 week

Study Arms (1)

Intervention group

EXPERIMENTAL

Each participant will receive a tablet-based aphasia therapy

Behavioral: Tablet-based aphasia therapy

Interventions

Tablet-based aphasia therapy BEHAVIORAL

patients will independently practice with a speech app during hospitalisation

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with aphasia after an ischemic or hemorrhagic stroke
• Maximum 2 weeks post-stroke
• Minimum 18 years old
• A minimum proficient language level of Dutch
• Signed informed consent

You may not qualify if:

• Presence of severe psychiatric disorders and/or cognitive disorders that hinder the use of the tablet-based aphasia therapy

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital, department of neurology

Ghent, 9000, Belgium

Location

Related Publications (1)

• De Cock E, Batens K, Feiken J, Hemelsoet D, Oostra K, De Herdt V. The feasibility, usability and acceptability of a tablet-based aphasia therapy in the acute phase following stroke. J Commun Disord. 2021 Jan-Feb;89:106070. doi: 10.1016/j.jcomdis.2020.106070. Epub 2020 Dec 29.

  PMID: 33418143 DERIVED

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Veerle De Herdt

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, clinical professor Veerle De Herdt

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 20, 2018
• Study Start: September 28, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

BE (1)