- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573936
Quality of Life in Adult Neurological Patients
April 6, 2012 updated by: Denise Midori Yoshihara, Associação de Assistência a Criança Deficiente
The Influence of Rehabilitation on Quality of Life in Adult Patients With Neurological Disorders
The purposes of this study were to evaluate the influence of an interdisciplinary rehabilitation program in the improvement of the health-related quality of life among adult neurological patients and to identify the sociodemographic and clinical associated characteristics.
Subjects with spinal cord injury, acquired brain injury and poliomyelitis survivors participated in the study.
All participants underwent a rehabilitation program (RP) from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2 days a week.
The WHOQOL-BREF was applied at the initial and discharge assessments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed with spinal cord injury, acquired brain injury and poliomyelitis survivors
- at least 18 years old
- consented to participate in the study
Exclusion Criteria:
- cognitive problems to understand and to respond the assessment instrument, according to medical files description and interviewer previous judgment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rehabilitation program
Rehabilitation program from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2 days a week
|
The mean duration of the RP was 7.47 ± 4.45 months, but it was not standardized because this factor was not one of the parameters of interest for this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHOQOL-BREF
Time Frame: participants will be followed for the duration of rehabilitation program, an expected average of 7 months
|
The brief version of the World Health Organization Quality of Life (WHOQOL-BREF) is a sound, cross-culturally valid assessment of health-related quality of life in adults populations.
Its assessment shows good to excellent internal consistency, test-retest reliability, discriminant validity, content validity, and construct validity in the healthy population and in different patient groups.
|
participants will be followed for the duration of rehabilitation program, an expected average of 7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
March 13, 2012
First Submitted That Met QC Criteria
April 6, 2012
First Posted (Estimate)
April 10, 2012
Study Record Updates
Last Update Posted (Estimate)
April 10, 2012
Last Update Submitted That Met QC Criteria
April 6, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Neuromuscular Diseases
- Central Nervous System Infections
- Enterovirus Infections
- Picornaviridae Infections
- Craniocerebral Trauma
- Trauma, Nervous System
- Spinal Cord Diseases
- Myelitis
- Brain Injuries
- Wounds and Injuries
- Spinal Cord Injuries
- Poliomyelitis
Other Study ID Numbers
- Yoshihara_AACD2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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