NCT05152979

Brief Summary

Although there is evidence that speech-language therapy may improve speech in language disorders following left hemisphere stroke there is still a lack of evidence for which types of therapy are effective. Furthermore, in Sweden, as well as in several other countries, access to speech-language therapy is limited. The purpose of this clinical trial is to compare outcome from Verb Network Strengthening Treatment (VNeST) provided as In-Clinic therapy (I-CT) or as synchronous telepractice therapy (TP-T).

Trial Health

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Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 16, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

October 18, 2021

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in naming ability of trained items at week 10.

    Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).

    Baseline, 10 weeks.

  • Change from baseline in naming ability of trained items at week 20.

    Naming of ten trained phrases including an agent (subject), verb and a patient (object) with moving picture stimuli. Possible score ranges from 0 (worst) to 40 (best).

    Baseline, 20 weeks.

Secondary Outcomes (12)

  • Change from baseline in naming ability of untrained items at week 10.

    Baseline, 10 weeks.

  • Change from baseline in naming ability of untrained items at week 20.

    Baseline, 20 weeks.

  • Change from baseline in confrontation naming of single words (objects and actions) at week 10.

    Baseline, 10 weeks.

  • Change from baseline in confrontation naming of single words (objects and actions) at week 20.

    Baseline, 20 weeks.

  • Change from baseline in confrontation naming of single words (objects) at week 10.

    Baseline, 10 weeks.

  • +7 more secondary outcomes

Study Arms (2)

Telepractice treatment (TP-T)

EXPERIMENTAL

Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST). Treatment will be done with a speech-language pathologist providing the therapy through an online platform.

Behavioral: Verb Network Strengthening Treatment (VNeST)

In-clinic treatment (IC-T)

ACTIVE COMPARATOR

Participants will receive 30 hours of training, 2-3 times a week in ten weeks using Verb Network Strengthening Treatment (VNeST). Treatment will be done with a speech-language pathologist providing the therapy in person at a clinic.

Behavioral: Verb Network Strengthening Treatment (VNeST)

Interventions

Participants are presented with a verb (representing an activity, for example, driving) orally and in writing. The participants are first asked to name someone who may perform the given activity (an agent, for example, a chauffeur), then to name an object which the given activity may be performed with (a patient, for example, a limousine). Several types of semantic clues and assistance are provided if the participant is having difficulties finding adequate nouns. This procedure is repeated for three different agents and objects related to the given verb. The participants are then asked to choose one of the three phrases participants have created and expand on it by telling where, when and why the agent is performing the activity. After this the participant are given sentences (with several foils) including the activity as well as agents and patients, and are asked to indicate whether the sentences are correct or not.

In-clinic treatment (IC-T)Telepractice treatment (TP-T)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aphasia and subjective experience of word finding difficulties
  • Diagnosed left-hemisphere stroke at least six months post-onset
  • With correction, sufficient hearing and vision to be able to participate in training and assessment
  • Primarily speaking Swedish for at least the last 15 years

You may not qualify if:

  • Other neurological injury or disease
  • Moderately or severely impaired comprehension
  • Moderate-severe apraxia of speech or dysarthria which may interfere with assessment
  • Participation in any other speech-language treatment during the study
  • Active substance dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg, Västra Götalandsregionen

Gothenburg, Västra Götaland County, 40530, Sweden

Location

Related Publications (7)

  • Baylor C, Yorkston K, Eadie T, Kim J, Chung H, Amtmann D. The Communicative Participation Item Bank (CPIB): item bank calibration and development of a disorder-generic short form. J Speech Lang Hear Res. 2013 Aug;56(4):1190-208. doi: 10.1044/1092-4388(2012/12-0140). Epub 2013 Jul 1.

    PMID: 23816661BACKGROUND
  • Edmonds LA. Tutorial for Verb Network Strengthening Treatment (VNeST): Detailed Description of the Treatment Protocol with Corresponding Theoretical Rationale. Perspectives on Neurophysiology & Neurogenic Speech & Language Disorders. 2014; 24(3): 78-88

    BACKGROUND
  • Goodglass H, Kaplan E, Weintraub S. Boston Naming Test. Philadelphia, PA: Lea & Febiger. 1983.

    BACKGROUND
  • Hilari K, Lamping DL, Smith SC, Northcott S, Lamb A, Marshall J. Psychometric properties of the Stroke and Aphasia Quality of Life Scale (SAQOL-39) in a generic stroke population. Clin Rehabil. 2009 Jun;23(6):544-57. doi: 10.1177/0269215508101729. Epub 2009 May 15.

    PMID: 19447841BACKGROUND
  • Long A, Hesketh A, Paszek G, Booth M, Bowen A. Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale. Clin Rehabil. 2008 Dec;22(12):1083-94. doi: 10.1177/0269215508090091.

    PMID: 19052247BACKGROUND
  • Masterson J, Druks J. Description of a set of 164 nouns and 102 verbs matched for printed word frequency, familiarity and age-of-acquisition. Journal of Neurolinguistics. 1998; 11: 331-54.

    BACKGROUND
  • Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.

    PMID: 8487525BACKGROUND

MeSH Terms

Conditions

AnomiaAphasiaStroke

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeech DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Charlotta Saldert, Prof

    Inst of Neurosci & Physiology, Speech & Language Pathology Unit, University of Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The results are assessed by independent assessors blinded to in which phase (pre-post-follow up) the data is obtained, and partly to conditions for therapy (In-Clinic or Telepractice).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2021

First Posted

December 10, 2021

Study Start

January 16, 2022

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations