Motor DysfunctionNCT02614677
To Advance the New Disability Evaluation System in Taiwan
An observational study of Motor Dysfunction, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Before 2007, the disability evaluation was based on the medical model in Taiwan. According to the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment of a person's eligibility for disability benefits has to be determined as suffering one of eight malfunction categories based on the… Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Motor Dysfunction
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Dec 2014
- Phase
- Observational
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with disabilities want to issue a disability identification
Who may be able to join
- comply with a standard of the disability evaluation
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Before 2007, the disability evaluation was based on the medical model in Taiwan. According to the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment of a person's eligibility for disability benefits has to be determined as suffering one of eight malfunction categories based on the International Classification of Functioning, Disability, and Health (ICF) framework. People with disabilities want to issue a disability identification and other welfare \& services need processes of evaluation \& assessment based on the ICF framework for the evaluation report and result of living need by the committee composed of professionals from medicine, social work, special education and employment counseling and evaluation.
In this year, investigators planed the project with the Taiwan Society of ICF to develop the evaluation form. The experts from various disciplines of the ICF Office convened internal integration meetings to reach a consensus for developed the ICF evaluation form, add the code of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire. The results were used to analysis other relevant factors affecting the disability evaluation. And then add the core set from World Health Organization to both physical and mental disorders linked coding group, compared the new disability evaluation system and evaluate the living need of people with disability to provide suggestion for core set.
- Conditions
- Motor Dysfunction
- Keywords
- Disability Evaluation System, SF-12, ICF model
- Medical subject headings
- Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Quality of life by disability evaluate system
Measured: One day when patients came first
Pain intensity on the Numerical Rating Scale
Measured: One day when patients came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DysfunctionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614677
- Sponsor's protocol ID
- CCH-140713
- Status last verified
- Nov 2015
- First submitted
- 8 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Advance the New Disability Evaluation System in Taiwan
- ClinicalTrials.gov ID
- NCT02614677
- Acronym / sponsor ID
- CCH-140713
- Conditions
- Motor Dysfunction
- Keywords
- Disability Evaluation System, SF-12, ICF model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Nov 2015 (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.
Before 2007, the disability evaluation was based on the medical model in Taiwan. According to the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment of a person's eligibility for disability benefits has to be determined as suffering one of eight malfunction categories based on the International Classification of Functioning, Disability, and Health (ICF) framework. People with disabilities want to issue a disability identification and other welfare \& services need processes of evaluation \& assessment based on the ICF framework for the evaluation report and result of living need by the committee composed of professionals from medicine, social work, special education and employment counseling and evaluation.
In this year, investigators planed the project with the Taiwan Society of ICF to develop the evaluation form. The experts from various disciplines of the ICF Office convened internal integration meetings to reach a consensus for developed the ICF evaluation form, add the code of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire. The results were used to analysis other relevant factors affecting the disability evaluation. And then add the core set from World Health Organization to both physical and mental disorders linked coding group, compared the new disability evaluation system and evaluate the living need of people with disability to provide suggestion for core set.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with disabilities want to issue a disability identification
Key inclusion criteria (1 listed)
- comply with a standard of the disability evaluation
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Quality of life by disability evaluate system
Time frame: One day when patients came first
Pain intensity on the Numerical Rating Scale
Time frame: One day when patients came first
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 25 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Dysfunction, run by Changhua Christian Hospital at 1 site in Taiwan.
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 1 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessment of Quality of life by disability evaluate system (time frame: One day when patients came first). The study lists 2 primary outcomes in all. 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 25 Nov 2015.