- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00764400
Treatment for Word Retrieval Impairments in Aphasia
4. april 2018 opdateret af: Dr. Anastasia Raymer, Old Dominion University
Communication Outcomes for Naming Treatments in Aphasia
In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia.
One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval.
Participants will receive one of the two treatments over several months.
Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments.
The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In this study the investigators are examining the effectiveness of two different speech therapy protocols for word retrieval impairments experienced by individuals with stroke-induced aphasia.
One treatment involves errorless naming treatment and the other employs verbal plus gestural facilitation of word retrieval.
Participants will receive one of the two treatments over several months.
Before and after treatment the investigators will administer several tests and conversational samples to examine changes associated with the treatments.
The investigators hypothesize that, whereas both treatments will lead to improvements in words rehearsed in therapy, communication outcomes in conversation will be broader for the verbal plus gestural protocol.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater, 23529
- Old Dominion University Speech and Hearing Clinic
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- left hemisphere stroke >4 months earlier
- aphasia with word retrieval impairments
- >21 years of age right handed
- speaker of English as the preferred language
- >6 grade education
Exclusion Criteria:
- history of developmental learning difficulties
- history of prior neurological illnesses
- chronic medical illnesses that restrict participation in speech therapy
- alcohol or drug dependence
- severe uncorrected impairments of vision or hearing
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Errorless Naming Treatment
|
Speech therapy sessions take place 4 times per week for up to 90 minutes per session.
Following a phase of baseline pre-testing, two phases of speech therapy will take place lasting up to 20 sessions per phase.
Post-testing will take place immediately upon completion of the treatment phases and again at 1 month post study completion.
|
|
Eksperimentel: Verbal+Gestural Facilitation
|
Speech therapy sessions take place 4 times per week for up to 90 minutes per session.
Following a phase of baseline pre-testing, two phases of speech therapy will take place lasting up to 20 sessions per phase.
Post-testing will take place immediately upon completion of the treatment phases and again at 1 month post study completion.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Daily Probe Picture Naming
Tidsramme: daily probes from three times per week for up to 3 months and one month posttreatment
|
daily probes from three times per week for up to 3 months and one month posttreatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Western Aphasia Battery
Tidsramme: pre-treatment and at treatment completion
|
pre-treatment and at treatment completion
|
|
Boston Naming Test
Tidsramme: pretreatment and at treatment completion
|
pretreatment and at treatment completion
|
|
Discourse Sample
Tidsramme: pre-treatment and at treatment completion
|
pre-treatment and at treatment completion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Anastasia M Raymer, PhD, Old Dominion University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2008
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først indsendt
30. september 2008
Først indsendt, der opfyldte QC-kriterier
30. september 2008
Først opslået (Skøn)
2. oktober 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. april 2018
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R15DC009690 (U.S. NIH-bevilling/kontrakt)
- 3R15DC009690 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .