Group Intervention Study for Individuals with Dysarthria Following Stroke and Their Carers in Pakistan

October 10, 2024 updated by: Saima maratab, Isra University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Sheikh Zayed medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 40 to 70 years age ranges
  2. History of dysarthria previous six monthes
  3. Primary level of education
  4. Functional hearing and visual ablities -

Exclusion Criteria:

  1. Patient with age below 40 to 70
  2. Patients with diagnosis severe psychological illness
  3. Patient with developmental dysarthria
  4. Patient who come alone without any attendent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Regular speech therapy
Regular speech therapy will be provided to the controlled group.
Other: Regular speech therapy
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.
Other: Group intervention
Group intervention will be provided to the experimental group.
Other: Group intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Isra University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saima M Ali, PhD, Isra University, Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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