Spinal Cord InjuryNCT01573936
Quality of Life in Adult Neurological Patients
A study testing Physical therapy, occupational therapy, psycotherapy, medical consultations in people with Spinal Cord Injury and Acquired Brain Injury, run by Associação de Assistência a Criança Deficiente.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Spinal Cord Injury, Acquired Brain Injury, Poliomyelitis
- What is being tested?
- Physical therapy, occupational therapy, psycotherapy, medical consultations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with spinal cord injury, acquired brain injury and poliomyelitis survivors
- at least 18 years old
- consented to participate in the study
Who cannot join
- cognitive problems to understand and to respond the assessment instrument, according to medical files description and interviewer previous judgment
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury, Acquired Brain Injury, Poliomyelitis
- Being tested
- Physical therapy, occupational therapy, psycotherapy, medical consultations
- Keywords
- acquired brain injury, health-related quality of life, poliomyelitis survivor, rehabilitation, spinal cord injury, completed the WHOQOL-BREF
- Medical subject headings
- Spinal Cord Injuries, Brain Injuries, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy, occupational therapy, psycotherapy, medical consultationsOther
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
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation program | Experimental | Rehabilitation program from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2 days a week Receives: Other: Physical therapy, occupational therapy, psycotherapy, medical consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHOQOL-BREF
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.
Measured: participants will be followed for the duration of rehabilitation program, an expected average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação de Assistência a Criança Deficiente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Midori Yoshihara, Associação de Assistência a Criança Deficiente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573936
- Sponsor's protocol ID
- Yoshihara_AACD2011
- Status last verified
- Apr 2012
- First submitted
- 13 Mar 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Rehabilitation on Quality of Life in Adult Patients With Neurological Disorders
- ClinicalTrials.gov ID
- NCT01573936
- Acronym / sponsor ID
- Yoshihara_AACD2011
- Conditions
- Spinal Cord Injury, Acquired Brain Injury, Poliomyelitis
- Keywords
- acquired brain injury, health-related quality of life, poliomyelitis survivor, rehabilitation, spinal cord injury, completed the WHOQOL-BREF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Associação de Assistência a Criança DeficienteUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rehabilitation program | Experimental | Other: Physical therapy, occupational therapy, psycotherapy, medical consultationsRehabilitation program from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2 days a week |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with spinal cord injury, acquired brain injury and poliomyelitis survivors
- at least 18 years old
- consented to participate in the study
Key exclusion criteria (1 listed)
- cognitive problems to understand and to respond the assessment instrument, according to medical files description and interviewer previous judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy, occupational therapy, psycotherapy, medical consultationsThe 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 | Other | rehabilitation program |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy, occupational therapy, psycotherapy, medical consultations in people with Spinal Cord Injury and Acquired Brain Injury, run by Associação de Assistência a Criança Deficiente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHOQOL-BREF (time frame: participants will be followed for the duration of rehabilitation program, an expected average of 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2012.