NCT04108364

Brief Summary

Rising life expectancy is leading to a rising incidence of strokes worldwide. Approximately one third of people who had a stroke live with a communication disorder, aphasia, which is associated with the largest negative relationship to quality of life. In chronic stages, people with aphasia (PwA) often do not receive any rehabilitation, despite treatment being shown to significantly reduce impairment. In contrast to existing computerized aphasia treatment, VoiceAdapt is an innovative and motivating application for PwA that provides adaptive and context-aware training lessons via speech interaction on the mobile device. A user-centred design process and motivational gamification ensure long-term engagement in training. Through providing an autonomously usable and low-cost tool, VoiceAdapt will positively affect PwA's self-esteem and social inclusion, leading to higher quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

September 26, 2019

Last Update Submit

September 11, 2024

Conditions

Aphasia

Keywords

aphasiaanomiarehabilitationspeech-language pathologymobile applicationslanguage therapystrokestroke rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in naming on the Boston Naming Test (BNT)

    Naming performance (out of 60) on the BNT

    baseline; 7 weeks; 13 weeks

Secondary Outcomes (3)

  • Change in Aphasia Quotient on the Western Aphasia Battery-Revised (WAB-R)

    baseline; 7 weeks; 13 weeks

  • Change in score on the Stroke and Aphasia Quality of Life Scale (SAQOL-39)

    baseline; 7 weeks; 13 weeks

  • Change in score on the Communication Effectiveness Index (CETI)

    baseline; 7 weeks; 13 weeks

Other Outcomes (1)

  • Situation Motivation Scale (SIMS) score

    7 weeks; 13 weeks

Study Arms (2)

VoiceAdapt Intervention

EXPERIMENTAL

PWA who train with VoiceAdapt app

Behavioral: Voice adaptive training for aphasia

No Intervention

NO INTERVENTION

PWA who are on the waitlist and not training with VoiceAdapt app

Interventions

Voice adaptive training for aphasiaBEHAVIORAL

Training with the VoiceAdapt tablet-based therapy app 25 hours (1 hr/day x 5 days/week x 5 weeks)

VoiceAdapt Intervention

Eligibility Criteria

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

You may qualify if:

  • be at least 6 months post onset of a single stroke in the left hemisphere
  • have aphasia of mild to moderate severity (Aphasia Quotient ≥ 30 on WAB--R) with a prominent verbal expression impairment.
  • pass screenings of visual perception (BORB), hearing (pure tone screening with portable audiometer), and basic cognitive functioning (Raven's Coloured Progressive Matrices)
  • speak English as a primary language.
  • be willing to commit to participation for study duration

You may not qualify if:

  • Currently participating in individual (one-on-one) speech-language therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G2G4, Canada

Location

University of Toronto

Toronto, Ontario, M5G 1V7, Canada

Location

Related Publications (1)

  • Kim ES, Laird L, Wilson C, Bieg T, Mildner P, Moller S, Schatz R, Schwarz S, Spang R, Voigt-Antons JN, Rochon E. Implementation and Effects of an Information Technology-Based Intervention to Support Speech and Language Therapy Among Stroke Patients With Aphasia: Protocol for a Virtual Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 2;10(7):e30621. doi: 10.2196/30621.

    PMID: 34255727DERIVED

MeSH Terms

Conditions

AphasiaAnomiaStroke

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

  • Esther S Kim, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Elizabeth Rochon, PhD

    University of Toronto

    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: two arm, randomized, waitlist-controlled, crossover group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 30, 2019

Study Start

October 1, 2020

Primary Completion

September 30, 2022

Study Completion

January 5, 2023

Last Updated

September 19, 2024

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)