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Implementation & Feasibility Study of Patients With Dysarthria Following Stroke & Their Carers in Pakistan

Primary Purpose

Dysarthria as Late Effect of Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group intervention
Regular speech therapy
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysarthria as Late Effect of Stroke focused on measuring Stroke, Dysarthia, Intervention

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sheikh Zayed medical ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Regular speech therapy

Group intervention

Arm Description

Regular speech therapy will be provided to the controlled group.

Group intervention will be provided to the experimental group.

Outcomes

Primary Outcome Measures

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.
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.
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2020
Last Updated
June 8, 2020
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT04427670
Brief Title
Implementation & Feasibility Study of Patients With Dysarthria Following Stroke & Their Carers in Pakistan
Official Title
Implementation and Feasibility Study of Group Intervention for Patients With Dysarthria Following Stroke and Their Carers in Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysarthria as Late Effect of Stroke
Keywords
Stroke, Dysarthia, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT with intervention having experimental group. random Allocation of participants.
Masking
Participant
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular speech therapy
Arm Type
Other
Arm Description
Regular speech therapy will be provided to the controlled group.
Arm Title
Group intervention
Arm Type
Other
Arm Description
Group intervention will be provided to the experimental group.
Intervention Type
Other
Intervention Name(s)
Group intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Regular speech therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Roberston Dysarthria Profile.
Description
Roberston Dysarthria Profile take responses on 5 point likert scale where 1 for worst and 5 for better outcome.
Time Frame
6 months
Title
efficacy of group intervention for Patients With Dysarthria will be assessed by translated version of Communication Effectivness Measure
Description
Communication Effectivness Measure is seven point scale arranging from 1 to 7 where 1 for worst outcome and 7 for better outcome.
Time Frame
6 months
Title
Efficacy of group intervention for Patients With Dysarthria will be assessed by the translated version of Communicative Participation Item Bank.
Description
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.
Time Frame
6 months
Title
Efficacy of group intervention for Patients With Dysarthria will be assessed by Gernal Health Questionnaire
Description
Gernal Health Questionnaire is four point scale in which responses 1 means better and 4 for worst condition
Time Frame
6 months
Title
Efficacy of group intervention for Patients With Dysarthria will be assessed by Speech Intelligiblity Test
Description
Speech Intelligiblity Test is three point scale where 2 stands for correct utterances and 0 shows wrong production of sounds.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sheikh Zayed medical Complex
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Suhail, M.Phil
Phone
+924299237024
Email
szmcirb1@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Implementation & Feasibility Study of Patients With Dysarthria Following Stroke & Their Carers in Pakistan

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