NCT03622411

Brief Summary

Aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits. There is evidence that intensive aphasia therapy is effective for language recovery, even in the chronic phase post-stroke. However, as many patients are left with residual language disorders and intensive aphasia rehabilitation is difficult to achieve, the investigators are exploring tablet-based therapies to further facilitate language recovery in a cost-effective manner.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

September 7, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

August 6, 2018

Last Update Submit

January 6, 2023

Conditions

AphasiaStroke

Outcome Measures

Primary Outcomes (1)

  • Boston Naming Test (BNT)

    Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty

    4 months

Secondary Outcomes (3)

  • Spontaneous speech of the Aachen Aphasia Test (AAT)

    4 months

  • Quality of life (SAQOL-39-Nl)

    4 months

  • Usability questionnaire

    1 day

Study Arms (3)

aphasia therapy + speech app

EXPERIMENTAL

3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks independent practice via the speech app

Device: speech appBehavioral: aphasia therapy

aphasia therapy + brain games

ACTIVE COMPARATOR

3 hours per week of conventional aphasia therapy during 3 weeks + 5 hours per week during 3 weeks of recreational tables use (brain games)

Device: brain gamesBehavioral: aphasia therapy

aphasia therapy

ACTIVE COMPARATOR

3 hours per week of conventional aphasia therapy during 3 weeks

Behavioral: aphasia therapy

Interventions

speech appDEVICE

language exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app

aphasia therapy + speech app
brain gamesDEVICE

language exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games

aphasia therapy + brain games
aphasia therapyBEHAVIORAL

language exercises provided by the speech therapist in hospital

aphasia therapyaphasia therapy + brain gamesaphasia therapy + speech app

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic stroke
  • age 18 - 85 years
  • being right-handed (according to the questionnaire for handedness, Van Strien)
  • mother tongue: Dutch
  • signed informed consent

You may not qualify if:

  • history of a previous stroke with persistent (\> 24 hours) language symptoms
  • history of other diseases of the central nervous system, psychological disorders and (developmental) speech and/or language disorders
  • serious non-linguistic, cognitive disorders (as documented in the patients' medical history)
  • inability to perform tablet-based tasks (based on a short training session)
  • excessive use of alcohol or drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, department of neurology

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Veerle De Herdt

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

September 7, 2018

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations

BE(1)