- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427670
Implementation & Feasibility Study of Patients With Dysarthria Following Stroke & Their Carers in Pakistan
June 8, 2020 updated by: Saima maratab, Isra University
Implementation and Feasibility Study of Group Intervention for Patients 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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
24
Phase
- 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
-
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- Sheikh Zayed medical Complex
-
Contact:
- Muhammad Suhail, M.Phil
- Phone Number: +924299237024
- Email: szmcirb1@gmail.com
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-
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
Ages Eligible for Study
38 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 40 to 70 years age ranges
- History of dysarthria previous six monthes
- Primary level of education
- Functional hearing and visual ablities -
Exclusion Criteria:
- Patient with age below 40 to 70
- Patients with diagnosis severe psychological illness
- Patient with developmental dysarthria
- 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 |
Intervention / Treatment |
---|---|
Other: Regular speech therapy
Regular speech therapy will be provided to the controlled group.
|
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.
|
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
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.
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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
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)
February 12, 2020
Primary Completion (Anticipated)
November 15, 2020
Study Completion (Anticipated)
November 30, 2020
Study Registration Dates
First Submitted
March 14, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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
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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