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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Aphasia, Broca
• Intervention / Treatment: Other: VESMP; Other: Traditional Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Rawalpindi, Pakistan, 44000
    • Pakistan Railway Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VESMP; Participants used VESMP at least half hour session thrice a week over an average of 4 months. The instruction before every domain included using it independently on the participant's own smart phone, or with a trained person either in the clinic or on their phone brought to the participant's home. Total 25 patients with diagnosis of severe non-fluent aphasia included, ages 40+, at least 3 months post-onset of single unilateral CVA affecting the language dominant hemisphere at the time of baseline testing also including, Participant demographics, aphasia classification and severity. All subjects participated in an intensive 2-week VESMP treatment program prior to beginning the individualized programs.	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.
Active Comparator: Traditional Therapy; Control group received traditional therapy total 25 patients with diagnosis of severe non-fluent aphasia included, All subjects participated in an traditional therapy group in routine and received language therapy for 4 months of periods with three sessions per week.	Other: 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.; Other Names: MIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Isra University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 24, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Aphasia; Broca Aphasia; communication skills; Verbal expressive skill management programme
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia; Aphasia, Broca
• Other Study ID Numbers: IIRS-IUISB/PHD/015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No