NCT03326687

Brief Summary

Many individuals have difficulty with word retrieval, also called anomia, following cerebrovascular accident (CVA). These difficulties impede effective communication in everyday conversations and can negatively impact the resumption of pre-injury activities. Even after rehabilitation specifically targeting these areas, many individuals report persistent difficulties with anomia. Additionally, most individuals report that these difficulties worsen when distracted, fatigued, or when attempting to divide attention between tasks. Given that everyday activities frequently require efficient communication when attention is divided (e.g., walking and talking), it is important to investigate viable interventions to improve these skills. Recovery from CVA and resumption of pre-injury activities is best supported by rehabilitation interventions that are functional and directly related to the tasks individuals aim to resume. For example, a therapy task requiring an individual to generate a grocery list and then go to a grocery store to acquire the items on the list has a greater impact on recovery for the underlying language and cognitive skills than a series of generic language and cognition tasks completed in a therapy room. In addition to this, interventions that incorporate dual-task practices tend to have better outcomes than more traditional single-task practices. The aim of this study is to compare the effectiveness of pairing word retrieval tasks with physical endurance tasks versus presenting them in isolation. Additionally, this study will investigate whether improvements in word retrieval and physical endurance generalize to the functional, everyday task of holding a conversation while walking. The researchers hypothesize that participants will perform better on word retrieval tasks after participating in dual language and physical tasks than after participating in language tasks presented in isolation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

October 20, 2017

Last Update Submit

June 11, 2018

Conditions

Keywords

LanguageAnomiaTherapy

Outcome Measures

Primary Outcomes (1)

  • Number of words named in a category

    The researcher will provide a participant with a category label. The participants will name as many words as he/she can in that category within a one-minute time period. The researcher will tally the total number of unique and category-appropriate words named.

    One or two times daily until discharge from the facility (up to 24 weeks).

Secondary Outcomes (3)

  • Distance traveled (in feet) while using an exercise machine

    One or two times daily until discharge from the facility (up to 24 weeks).

  • Number of words generated during discourse

    Two times per week until discharge from the facility (up to 24 weeks).

  • Distance traveled (in feet) while walking

    Two times per week until discharge from the facility (up to 24 weeks).

Study Arms (2)

Treatment ABAB

EXPERIMENTAL

Participants will receive anomia treatment in isolation and will perform a physical endurance task in isolation during A phases. They will receive anomia treatment in combination with performing a physical endurance task during B phases.

Behavioral: Treatment ABAB

Treatment BABA

EXPERIMENTAL

Participants will receive anomia treatment in isolation and will perform a physical endurance task in isolation during A phases. They will receive anomia treatment in combination with performing a physical endurance task during B phases.

Behavioral: Treatment BABA

Interventions

Treatment ABABBEHAVIORAL

Participants will perform the phases in the ABAB order.

Treatment ABAB
Treatment BABABEHAVIORAL

Participants will perform the phases in the BABA order.

Treatment BABA

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have acquired brain injury due to left cerebrovascular accident (CVA)
  • Be older than 19 years of age
  • Speak English as a native language
  • Be less than 3 months post-left CVA at the time of participation initiation
  • Use natural speech as a primary means of communicating
  • Have hearing adequate for conversational speech
  • Have mild to moderate deficits in word retrieval and physical endurance as a result of left CVA
  • Be currently receiving treatment services at Quality Living for CVA-related deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quality Living

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

AphasiaLanguageAnomia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCommunicationBehavior

Study Officials

  • Karen A Hux, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR
  • Carly R Dinnes, MA

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: All participants will receive both the isolated and combined treatments in an ABAB or BABA order of phases.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

October 31, 2017

Study Start

May 1, 2018

Primary Completion

June 8, 2018

Study Completion

June 8, 2018

Last Updated

June 13, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

The researchers do not plan to share IPD because of the potential for violation of participants' privacy and confidentiality is too great given the participant pool.

Locations