NCT04427670

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

12 months

First QC Date

March 14, 2020

Last Update Submit

October 10, 2024

Conditions

Keywords

StrokeDysarthiaIntervention

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Regular speech therapy

OTHER

Regular speech therapy will be provided to the controlled group.

Other: Regular speech therapy

Group intervention

OTHER

Group intervention will be provided to the experimental group.

Other: Group intervention

Interventions

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.

Group intervention

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.

Regular speech therapy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years age ranges
  • History of dysarthria previous six monthes
  • Primary level of education
  • Functional hearing and visual ablities -

You may not qualify if:

  • Patient with age below 40 to 70
  • Patients with diagnosis severe psychological illness
  • Patient with developmental dysarthria
  • Patient who come alone without any attendent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Saima M Ali, PhD

    Isra University, Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT with intervention having experimental group. random Allocation of participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 14, 2020

First Posted

June 11, 2020

Study Start

December 1, 2020

Primary Completion

November 15, 2021

Study Completion

July 12, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations