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

NCT03699605 | Completed DMC

• 1 other identifier: IIRS-IUISB/PHD/015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aphasia, Broca; Stroke

Keywords

Stroke; Aphasia; Broca Aphasia; communication skills; Verbal expressive skill management programme

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

VESMP

EXPERIMENTAL

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

Traditional Therapy

ACTIVE COMPARATOR

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

Interventions

VESMP OTHER

. 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.

VESMP

Traditional Therapy OTHER

, 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.

Also known as: MIT

Traditional Therapy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Broca Aphasic patients having cognitive impairment
• The patients having tumors, infections and trauma

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, 44000, Pakistan

Location

Related Publications (1)

• Kiyani HS, Naz S, Mubeen R, Zubair R. Effectiveness of a Verbal Expressive Skills Management Program for Pakistani Patients with Broca Aphasia: A Randomized Clinical Trial. Altern Ther Health Med. 2023 Sep;29(6):204-208.

  PMID: 37295011 DERIVED

MeSH Terms

Conditions

Aphasia, Broca; Stroke; Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The two groups were included for speech therapy. For any given subject, aphasia severity evaluations were completed on the same day.includes patients that are 40+ years old, and have three months of post stroke with diagnosis of chronic Broca's Aphasias, each patient received treatment for 4 months that includes 04 VESMP sessions per week with each session being 30-45 minutes long. The measurement will be taken at 0 week (baseline) after 16 weeks.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: November 2, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)