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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04427670
Other study ID # 201/2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 12, 2020
Est. completion date November 30, 2020

Study information

Verified date June 2020
Source Isra University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date November 30, 2020
Est. primary completion date November 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Pakistan Sheikh Zayed medical Complex Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 6 months
Primary 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. 6 months
Primary 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 6 months
Primary 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. 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05877950 - The Effectiveness of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria N/A
Recruiting NCT05865106 - The Efficacy and Feasibility of Smartphone-Based Speech Therapy for People With Post-Stroke Dysarthria N/A
Completed NCT05146765 - Efficacy of a Digital Therapeutic for People With Dysarthria After Stroke N/A