AphasiaNCT05697549
Effects of Cognitive Behavior Language Therapy for Patients With Post Stroke Aphasia
A study testing cognitive behavior language therapy in people with Aphasia, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- cognitive behavior language therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Below 30 years of age.
- Patients with aphasia caused by a non-stroke etiology.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aphasia
- Being tested
- cognitive behavior language therapy
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavior language therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: cognitive behavior language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 May 2023
- Primary completion15 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleena Irum, MSLP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697549
- Sponsor's protocol ID
- aleena1irum
- Status last verified
- Dec 2023
- First submitted
- 4 Jan 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Behavior Language Therapy for Patients With Post Stroke Aphasia
- ClinicalTrials.gov ID
- NCT05697549
- Acronym / sponsor ID
- aleena1irum
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive behavior language therapy | Experimental | Behavioral: cognitive behavior language therapyCognitive 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Below 30 years of age.
- Patients with aphasia caused by a non-stroke etiology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavior language therapyCognitive 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. | Behavioural | cognitive behavior language therapy |
Primary outcome
Cognitive linguistic quick test
Time frame: 4 week
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.
Speech language and helpful thoughts and belief scale
Time frame: 4 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Aphasia
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleena Irum, MSLP principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavior language therapy in people with Aphasia, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive linguistic quick test (time frame: 4 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.