NCT05697549

Brief Summary

This study is clinical trial based and the target population in this study is patients with post-stroke aphasia. Cognitive linguistic quick test (CLQT) and Speech Language unhelpful thoughts and belief scale (SLUTBS) will apply as an assessment. Inclusive criteria include diagnosed male and female post-stroke severe aphasia patients above 30 years of age. These participants must have high instance of unhelpful speech language thoughts and belief. Participants in inclusive criteria must not be participated in any other psychotherapy/ speech language intervention program. Participants must sign an informed consent form. Participants having a caregiver who is willing to be present during the period of intervention. Exclusive criteria include individuals below 30 years of age and patients with aphasia caused by non-stroke etiology. The aim of the study is to check the effects of cognitive behavior language therapy on patients with post-stroke aphasia. So, it will help speech language pathologists to adopt the principles of CBLT intervention to treat aphasia that occurs as a result of aphasia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

January 4, 2023

Last Update Submit

December 26, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cognitive linguistic quick test

    scoring 3.5 to 4 indicates attention, memory, executive functions, language, visuospatial skills are within the normal limit. whereas scoring 1 to 1.4 indicates that individual has severely affected in these areas.

    4 week

  • Speech language and helpful thoughts and belief scale

    the scoring of this scale according to 4. Likert scale. In which ''4'' strongly agree indicates high communication gap while sharing thoughts with others and ''1'' strongly disagree indicates individuals haven't facing any difficulties while sharing thoughts.

    4 week

Study Arms (1)

cognitive behavior language therapy

EXPERIMENTAL

Cognitive behavior language therapy is an extensive form of CBT. And it is focused on the treatment of speech-language related problems. CBLT helped the individuals to change their unhelpful thoughts and beliefs that cause difficulty for them to communicate properly and effectively. The main aim of CBLT is to use their remaining language abilities, to restore their language abilities and to learn the other ways of communication i.e. pointing, gesturing and AAC.

Behavioral: cognitive behavior language therapy

Interventions

Cognitive behavior language therapy is an extensive form of Cognitive behavior therapy. and it is used in the management of speech-language related problems. It helps the individuals to change their unhelpful thoughts and beliefs that cause difficulty for them to communicate properly and effectively. and it also helps the individuals to use their remaining language abilities, to restore their language abilities and to learn the other ways of communication i.e. pointing, gesturing and Augmentative alternative communication.

cognitive behavior language therapy

Eligibility Criteria

Age30 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsboth male and female will be included.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female.
  • Over 30 years of age.
  • All types of diagnosed aphasia.
  • Severe aphasia following stroke.
  • High instance of unhelpful speech language thoughts and belief.
  • Participants who are not participating in any other psychotherapy / speech language intervention program will be included.
  • Participants who are willing to sign an informed consent form.
  • Participants having a caregiver who is willing to be present during the period of intervention.

You may not qualify if:

  • Below 30 years of age.
  • Patients with aphasia caused by a non-stroke etiology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zaid

Rahim Yar Khan, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Aleena Irum, MSLP

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 26, 2023

Study Start

May 30, 2023

Primary Completion

September 15, 2023

Study Completion

October 15, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations