NCT04717180

Brief Summary

Aphasia is a disorder of language processing caused by a lesion in particular brain regions. Treatment aims at improving or restoring impaired function or at compensating for deficits. More recently, computer technology has been integrated into treatment options. In this study, a detailed and comprehensive computerized software program for aphasia rehabilitation is designed for the treatment of Arabic speaking Egyptian aphasic patients. Aim of the study: design a computerized software program for the rehabilitation of Arabic speaking Egyptian aphasic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration 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

Study Start

First participant enrolled

January 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

January 2, 2021

Last Update Submit

January 19, 2021

Conditions

Keywords

aphasia, post stroke

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was a measure of improvement in language abilities.

    The primary outcome was a measure of improvement in language abilities. It was measured (after 48 sessions) using Boston Diagnostic Aphasia Examination (BDAE) Arabic version to detect any significant improvement in language

    6 months

Study Arms (2)

group I

ACTIVE COMPARATOR

patients who received rehabilitation using the software program for aphasia rehabilitation

Behavioral: aphasia rehabilitation using software program or conventional therapy

group II

ACTIVE COMPARATOR

patients who received rehabilitation using the conventional therapy

Behavioral: aphasia rehabilitation using software program or conventional therapy

Interventions

Patients were randomized into two groups: group I who received therapy using the software aphasia rehabilitation program and group II who received conventional (traditional) language therapy

Also known as: aphasia rehabilitation using the conventional language therapy
group Igroup II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of aphasia
  • Age 18 years or more

You may not qualify if:

  • Intellectual disabilities.
  • Visual impairment.
  • Hearing impairment.
  • Associated dysarthria and or apraxia of speech.
  • Associated psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Main University Hospitals

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 22, 2021

Study Start

January 1, 2018

Primary Completion

September 15, 2019

Study Completion

June 20, 2020

Last Updated

January 22, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations