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CompletedNCT03699605VESMPUpdated Aug 28, 2019

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

An interventional study of VESMP and Traditional Therapy in Aphasia, Broca and Stroke, sponsored by Isra University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-08-28.

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

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aphasia, Broca
  • Stroke

Keywords

  • Stroke
  • Aphasia
  • Broca Aphasia
  • communication skills
  • Verbal expressive skill management programme
03

In context

Aphasia, Broca

43 studies on the registry are indexed under Aphasia, Broca; 13 are open to participants now.

This study's enrollment of 50 is above the median of 30 across 39 interventional studies indexed under Aphasia, Broca.

Browse Aphasia, Broca studies →

Lead sponsor

Isra University is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    • Broca Aphasic patients having cognitive impairment

      • The patients having tumors, infections and trauma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherVESMP

    . 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.

  • OtherTraditional 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.

    Also known as: MIT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 16 weeks

  2. 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

    Time frame: 16 weeks

07

Study locations

1 site
  • Pakistan Railway Hospital
    Rawalpindi, 44000, Pakistan
08

References and documents

Publications

  • 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. PubMed 37295011 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Apr 2019, 5 months.

Of 17 interventional studies with no phase under Aphasia, Broca, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 57. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2018
First posted
Oct 9, 2018
StartActual
Nov 2, 2018
Primary completionActual
Apr 30, 2019
CompletionActual
Jun 30, 2019
Last update
Aug 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03699605
Lead sponsor
Isra University
Responsible party
Humaira Shamim (Assistant Professor, Riphah International University) — Principal investigator
First posted
Oct 9, 2018
Start date
Nov 2, 2018
Primary completion
Apr 30, 2019
Completion
Jun 30, 2019
Last update
Aug 28, 2019

Oversight

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

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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