Development and Feasibility Analysis of Verbal Expressive Skills Management Programme (VESMP) for Patients With Broca Aphasia

Stroke Clinical Trial

— VESMP  

Official title:

Development and Feasibility Analysis of Verbal Expressive Skills Management Programme (VESMP) for Patients With Broca Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699605
• Other study ID #: IIRS-IUISB/PHD/015
• Status: Completed
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Isra University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study was conducted to develop the verbal expressive skills management programme (VESMP) to enhance verbal expressive skills of patients with severe Broca aphasia. To determine the efficacy of VESMP in improving the quality of life and level of satisfaction of aphasic stroke patients.Control group received traditional therapy and experimental group received therapy through VESMP programme on their smart phones.

Description:

Speech therapy makes an integral part of the non-pharmacological, conservative management of Post stroke aphasia. Routine speech therapy aims to improve comprehension and verbal skills and also develop functional communication skills through augmentative Alternative communication devices. Disorders of communication, including aphasia (mainly post stroke) caused by the left hemisphere brain damage, is a major community health issue. Aphasia is a language disorder occurring mainly as a result of stroke. It is an acquired impairment of language that weakens people's ability of comprehension and expression, it does not show any affect to intellect ability. The verbal expressive skills management programme (VESMP) is the software which developed augmented management for patients to enhance verbal expressive skills for patients with severe Broca's aphasia from different geographic areas.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• The 40-60 year Broca aphasia patients

• The severe Broca aphasia patients (more than 03 month of onset of stroke) Both infarct and hemorrhagic stroke

• Either gender Informed consent

Exclusion Criteria:

• • Broca Aphasic patients having cognitive impairment

• The patients having tumors, infections and trauma

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Stroke

Intervention

Other:
• VESMP
. The application contains following seven domains: spontaneous speech, comprehension, naming, reading, writing, imitation and automated speech. The programme was developed in Urdu language which contains different daily functional words, phrases and sentences. Treatment stimuli consisted of images of objects along with auditory sounds of person and actions cues. The voice output can operate by pressing the selected picture with index finger. Participants received 1-16 weeks of therapy using software of two domains with different difficulty levels. Specifically the programme included seven domains within the software comprising of eight 30-45 minutes sessions (4 days per week for total 16weeks). The measurement will be taken at 0 week (baseline) after 16 weeks.
• Traditional Therapy
, All subjects participated in an traditional therapy group in routine and received MIT for 4 months of periods with three sessions per week to improve language skills.

Locations

Country	Name	City	State
Pakistan	Pakistan Railway Hospital	Rawalpindi

Sponsors (1)

Lead Sponsor	Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Diagnostic Aphasia Examination Battery (BDAE)	The Boston Diagnostic Aphasia Examination Battery (BDAE) was administered to all participants pre-and post-VESMP. The BDAE is a comprehensive standardized test of language performance for individuals with aphasia that includes measures of spoken language, naming, auditory comprehension, reading and other modalities.	16 weeks
Primary	Stroke Quality of life Scale	Scoring: each item shall be scored with the following key Total help - Couldn't do it at all - Strongly agree 1 A lot of help - A lot of trouble - Moderately agree 2 Some help - Some trouble - Neither agree nor disagree 3 A little help - A little trouble - Moderately disagree 4 No help needed - No trouble at all - Strongly disagree 5	16 weeks