Dysarthria As Late Effect of StrokeNCT04427670
Group Intervention Study for Individuals with Dysarthria Following Stroke and Their Carers in Pakistan
A study testing Group intervention and Regular speech therapy in people with Dysarthria As Late Effect of Stroke, run by Isra University at 1 site in Pakistan.
Trial summary
Dysarthria is a common problem in Pakistan. therefore the current study aims to translate the dysarthria communication tools into urdu language for better understanding the population and the problem Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysarthria As Late Effect of Stroke
- What is being tested?
- Group intervention and Regular speech therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2020to 12 Jul 2024
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 to 70 years age ranges
- History of dysarthria previous six monthes
- Primary level of education
- Functional hearing and visual ablities -
Who cannot join
- Patient with age below 40 to 70
- Patients with diagnosis severe psychological illness
- Patient with developmental dysarthria
- Patient who come alone without any attendent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Feasibility Study of Group Intervention for Individuals with Dysarthria Following Stroke and Their Carers in Pakistan
Dysarthria is a common problem in Pakistan. therefore the current study aims to translate the dysarthria communication tools into urdu language for better understanding the population and the problem
Read the detailed description
Dysarthria is the inefficiency or restricted capability to form intelligible speech because of the inability of motor control on the speech structures. There are many therapeutic approaches in Pakistan that are in use for the patients with dysarthria following stroke. One of them is one to one intervention which may include one dysarthria client along with the speech therapist. The therapist delivers step by step instructions to the client. The essential assessments are being held to initiate the treatment. The application of this intervention approach leaves some drawbacks, such as, the patients find it difficult to relate and adapt to the treatment offered. Generalization also seems to be complicated. The patients express a lack in motivation and support. The other mode of approach is group intervention, in which multiple dysarthria clients along with their caregivers \& speech therapist are included. In the later one, there are greater chances of recovery for patients as they get peer support and build confidence through newfound friends, peer communication with realistic social setting, learning through teaching, increased awareness of skills and it is time constraints. The culture of practicing group sessions with dysarthria patients is lacked in Pakistan, which intends to meet and compensate for all the drawbacks and lacks of one on one intervention. By including the Dysarthria patients, therapist and the caregivers in the group intervention, there're greater chances of reduced anxiety for both patients \& caregivers regarding disorder \& its recovery.
- Conditions
- Dysarthria As Late Effect of Stroke
- Being tested
- Group intervention, Regular speech therapy
- Keywords
- Stroke, Dysarthia, Intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group interventionOther
Group intervention programme designed for stroke survivors with dysarthria and their carers. The programme was eight weeks long, with weekly two sessions, each session lasting for two hours, lead by speech language therapist and was comprised of activities which addressed participants education about their dysarthria and stroke. The role of family , peer and professional was to provide support and communication practice.
Regular speech therapyOther
Regular speech therapy will be provided to the controlled group.Regular speech therapy is one to one speech therapy session,conducted twice a week for the duration of eight weeks.This intervention is implemented to patients with dysarthria following stroke in a format of one patient and one therapist per session.
| Study group | Role | What they receive |
|---|---|---|
| Regular speech therapy | Other | Regular speech therapy will be provided to the controlled group. Receives: Other: Regular speech therapy |
| Group intervention | Other | Group intervention will be provided to the experimental group. Receives: Other: Group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Roberston Dysarthria Profile.
Roberston Dysarthria Profile take responses on 5 point likert scale where 1 for worst and 5 for better outcome.
Measured: 6 months
efficacy of group intervention for Patients With Dysarthria will be assessed by translated version of Communication Effectivness Measure
Communication Effectivness Measure is seven point scale arranging from 1 to 7 where 1 for worst outcome and 7 for better outcome.
Measured: 6 months
Efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Communicative Participation Item Bank.
Communicative Participation Item Bank is four point scale arranging from 0 to 3 where 0 for better communication participation and 3 for worst communication participation.
Measured: 6 months
Efficacy of group intervention for Patients With Dysarthria will be assessed by Gernal Health Questionnaire
Gernal Health Questionnaire is four point scale in which responses 1 means better and 4 for worst condition
Measured: 6 months
Efficacy of group intervention for Patients With Dysarthria will be assessed by Speech Intelligiblity Test
Speech Intelligiblity Test is three point scale where 2 stands for correct utterances and 0 shows wrong production of sounds.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Dec 2020
- Primary completion15 Nov 2021
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysarthria As Late Effect of StrokeStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- RCT with intervention having experimental group. random Allocation of participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saima maratab, Isra University
- Investigators
- Saima M Ali, PhD, Principal investigator, Isra University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427670
- Sponsor's protocol ID
- 201/2020
- Status last verified
- Oct 2024
- First submitted
- 14 Mar 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Feasibility Study of Group Intervention for Individuals with Dysarthria Following Stroke and Their Carers in Pakistan
- ClinicalTrials.gov ID
- NCT04427670
- Acronym / sponsor ID
- 201/2020
- Conditions
- Dysarthria As Late Effect of Stroke
- Keywords
- Stroke, Dysarthia, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 11 Jun 2020 (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.
Dysarthria is a common problem in Pakistan. therefore the current study aims to translate the dysarthria communication tools into urdu language for better understanding the population and the problem
Detailed description
Dysarthria is the inefficiency or restricted capability to form intelligible speech because of the inability of motor control on the speech structures. There are many therapeutic approaches in Pakistan that are in use for the patients with dysarthria following stroke. One of them is one to one intervention which may include one dysarthria client along with the speech therapist. The therapist delivers step by step instructions to the client. The essential assessments are being held to initiate the treatment. The application of this intervention approach leaves some drawbacks, such as, the patients find it difficult to relate and adapt to the treatment offered. Generalization also seems to be complicated. The patients express a lack in motivation and support. The other mode of approach is group intervention, in which multiple dysarthria clients along with their caregivers \& speech therapist are included. In the later one, there are greater chances of recovery for patients as they get peer support and build confidence through newfound friends, peer communication with realistic social setting, learning through teaching, increased awareness of skills and it is time constraints. The culture of practicing group sessions with dysarthria patients is lacked in Pakistan, which intends to meet and compensate for all the drawbacks and lacks of one on one intervention. By including the Dysarthria patients, therapist and the caregivers in the group intervention, there're greater chances of reduced anxiety for both patients \& caregivers regarding disorder \& its recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT with intervention having experimental group. random Allocation of participants.
| Arm | Type | Receives |
|---|---|---|
| Regular speech therapy | Other | Other: Regular speech therapyRegular speech therapy will be provided to the controlled group. |
| Group intervention | Other | Other: Group interventionGroup intervention will be provided to the experimental group. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40 to 70 years age ranges
- History of dysarthria previous six monthes
- Primary level of education
- Functional hearing and visual ablities -
Key exclusion criteria (4 listed)
- Patient with age below 40 to 70
- Patients with diagnosis severe psychological illness
- Patient with developmental dysarthria
- Patient who come alone without any attendent
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 |
|---|---|---|
| Group interventionGroup intervention programme designed for stroke survivors with dysarthria and their carers. The programme was eight weeks long, with weekly two sessions, each session lasting for two hours, lead by speech language therapist and was comprised of activities which addressed participants education about their dysarthria and stroke. The role of family , peer and professional was to provide support and communication practice. | Other | Group intervention |
| Regular speech therapyRegular speech therapy will be provided to the controlled group.Regular speech therapy is one to one speech therapy session,conducted twice a week for the duration of eight weeks.This intervention is implemented to patients with dysarthria following stroke in a format of one patient and one therapist per session. | Other | Regular speech therapy |
Primary outcome
efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Roberston Dysarthria Profile.
Time frame: 6 months
Roberston Dysarthria Profile take responses on 5 point likert scale where 1 for worst and 5 for better outcome.
efficacy of group intervention for Patients With Dysarthria will be assessed by translated version of Communication Effectivness Measure
Time frame: 6 months
Communication Effectivness Measure is seven point scale arranging from 1 to 7 where 1 for worst outcome and 7 for better outcome.
Efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Communicative Participation Item Bank.
Time frame: 6 months
Communicative Participation Item Bank is four point scale arranging from 0 to 3 where 0 for better communication participation and 3 for worst communication participation.
Efficacy of group intervention for Patients With Dysarthria will be assessed by Gernal Health Questionnaire
Time frame: 6 months
Gernal Health Questionnaire is four point scale in which responses 1 means better and 4 for worst condition
Efficacy of group intervention for Patients With Dysarthria will be assessed by Speech Intelligiblity Test
Time frame: 6 months
Speech Intelligiblity Test is three point scale where 2 stands for correct utterances and 0 shows wrong production of sounds.
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 15 Oct 2024.
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.
Saima M Ali, PhD principal investigator
Isra University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group intervention and Regular speech therapy in people with Dysarthria As Late Effect of Stroke, run by Isra 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 4 inclusion and 4 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 15 Oct 2024. 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?
efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Roberston Dysarthria Profile. (time frame: 6 months). The study lists 5 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 15 Oct 2024.