NCT02768922

Brief Summary

This study aims at contributing with scientific evidence to the field of aphasia telerehabilitation. In Norway today, there is an unmet need for language training in post stroke aphasia and not all patients are offered language training. Early start of aphasia rehabilitation and satisfying intensity do not seem to be standard clinical practice. Language training by telemedicine could improve this situation, and this study seeks to answer the question whether aphasia rehabilitation delivered by videoconference can improve language function in aphasia post stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2016

Typical duration for not_applicable stroke

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

May 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

2.4 years

First QC Date

April 25, 2016

Last Update Submit

March 28, 2019

Conditions

Keywords

TelemedicineTelerehabilitationSpeech and language therapy

Outcome Measures

Primary Outcomes (1)

  • Naming ability assessed by NGA

    Will be assessed by the Norwegian Basic Aphasia Assessment (NGA) subtest "naming"

    four month post randomization

Secondary Outcomes (12)

  • Language function other than naming (repetition) assessed by NGA

    four month post randomization

  • Language function other than naming (comprehension ) assessed by NGA

    four month post randomization

  • Sentence Production by VAST

    four month post randomization

  • Sentence Production by VAST

    immediately after intervention (4 weeks)

  • Functional communication assessed by CETI

    four month post randomization

  • +7 more secondary outcomes

Study Arms (2)

Aphasia telerehabilitation

EXPERIMENTAL

Speech and language therapy is given by telemedicine to improve expressive language function. The therapy will include knowledge based tasks of aphasia rehabilitation including training of language forms and overall functional communication. A special emphasis will be put on naming training. The telerehabilitation will be given in a addition to standard face-to-face aphasia rehabilitation

Other: Aphasia telerehabilitationOther: Standard face-to-face aphasia rehabilitation

Control

ACTIVE COMPARATOR

Control Group receives standard face-to-face aphasia rehabilitation

Other: Standard face-to-face aphasia rehabilitation

Interventions

Speech and language therapy delivered by speech-language pathologist via computer and telemedicine

Aphasia telerehabilitation

Speech and language therapy delivered by speech-language pathologist face-to-face (treatment as usual)

Aphasia telerehabilitationControl

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with aphasia following stroke (all stages of aphasia post stroke)
  • Aphasia including naming impairment (percentile score of 70 or lower on the NGA - subtest naming)

You may not qualify if:

  • Age: \< 16 years
  • Patients who are unable to perform 5 hours of speech and language therapy per week due to medical or cognitive reasons (Including vision and hearing impairment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnaas Rehabilitation Hospital

Nesoddtangen, 1453, Norway

Location

Related Publications (2)

  • Ora HP, Kirmess M, Brady MC, Sorli H, Becker F. Technical Features, Feasibility, and Acceptability of Augmented Telerehabilitation in Post-stroke Aphasia-Experiences From a Randomized Controlled Trial. Front Neurol. 2020 Jul 31;11:671. doi: 10.3389/fneur.2020.00671. eCollection 2020.

  • Ora HP, Kirmess M, Brady MC, Winsnes IE, Hansen SM, Becker F. Telerehabilitation for aphasia - protocol of a pragmatic, exploratory, pilot randomized controlled trial. Trials. 2018 Apr 2;19(1):208. doi: 10.1186/s13063-018-2588-5.

Related Links

MeSH Terms

Conditions

StrokeAphasiaCommunication Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Frank Becker, PhD

    Sunnaas Rehabilitation Hospital

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Clinical Medical Director, Associate professor

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 11, 2016

Study Start

May 3, 2016

Primary Completion

September 27, 2018

Study Completion

December 31, 2018

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

The project will result in a Doctor of Philosophy (PhD) -thesis based on articles in international peer-reviewed scientific journals. In addition, the results of the project will be disseminated through national and international conference contributions as well as Norwegian publications in scientific journals, journals of user organizations and media contributions.

Locations