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CompletedNCT04427670Updated Oct 15, 2024

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

An interventional study of Group intervention and Regular speech therapy in Dysarthria As Late Effect of Stroke, sponsored by Isra University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Isra University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dysarthria As Late Effect of Stroke

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Keywords

  • Stroke
  • Dysarthia
  • Intervention
03

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Other
    Regular speech therapy

    Regular speech therapy will be provided to the controlled group.

    Other: Regular speech therapy

  • Other
    Group intervention

    Group intervention will be provided to the experimental group.

    Other: Group intervention

Interventions

  • OtherGroup 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.

  • OtherRegular 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

  4. 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

    Time frame: 6 months

  5. 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.

    Time frame: 6 months

06

Study locations

1 site
  • Sheikh Zayed medical Complex
    Lahore, Punjab 54000, Pakistan
07

Registry details

Key details

Study ID
NCT04427670
Lead sponsor
Isra University
Responsible party
Saima maratab (principle investigator, Isra University) — Principal investigator
First posted
Jun 11, 2020
Start date
Dec 1, 2020
Primary completion
Nov 15, 2021
Completion
Jul 12, 2024
Last update
Oct 15, 2024

Study contacts

Saima M Ali, PhD
principal investigator · Isra University, Islamabad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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