StrokeNCT02802956
A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program
A study testing Daily Life Promotion Program and general rehabilitation treatment in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Daily Life Promotion Program and general rehabilitation treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2016to Dec 2018
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with stroke after 6 months.
- Must be able to follow orders and no other cognition impairment, Mini Mental State Examination scale must >20.
Who cannot join
- Clinical diagnosis of Dementia or Psychosis.
- Clinical diagnosis of Musculoskeletal disorders or Nervous system diseases.
- Patient with Congestive Heart Failure, Hypertension, Atrial fibrillation.
- Could not communication with others.
- Foreigner.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Test2, test3
Yang Yi-Jiun, BS, 886-2-23123456 ext. 67313, yangyijiun@yahoo.com.tw
About this study
Official title: National Taiwan University Hospital, Taiwan
Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke
Read the detailed description
The purpose of this three-year research project is to develop an intervention program to promote participation in daily life for patients with chronic stroke and to evaluate its efficacy.
- Conditions
- Stroke
- Being tested
- Daily Life Promotion Program, general rehabilitation treatment
- Keywords
- Life participation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Life Promotion ProgramOther
Daily Life Promotion Program
general rehabilitation treatmentOther
general rehabilitation treatment
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Daily Life Promotion Program Receives: Other: Daily Life Promotion Program |
| control group | Experimental | general rehabilitation treatment Receives: Other: general rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale(SIS)
quality of life measure
Measured: one year
Secondary outcomes (7)
Postural Assessment Scale for Stroke patients(PASS)
motor performance measure
Measured: one year
Action Research Arm Test(ARAT)
motor performance measure
Measured: one year
Fugl-Meyer Assessment(FMA)
motor performance measure
Measured: one year
self-rated abilities for health practice scale
self-efficacy factors measure
Measured: one year
WHO Quality of Life-BREF (Taiwan version)
quality of life measure
Measured: one year
Taiwan Instrumental Activities of Daily Living(TIADL)
self-care ability measure
Measured: one year
Barthel Index
self-care ability measure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I MING HSIAO, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802956
- Sponsor's protocol ID
- 201509087RINC
- Status last verified
- Jun 2016
- First submitted
- 3 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital, Taiwan
- ClinicalTrials.gov ID
- NCT02802956
- Acronym / sponsor ID
- 201509087RINC
- Conditions
- Stroke
- Keywords
- Life participation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Jun 2016 (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.
Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke
Detailed description
The purpose of this three-year research project is to develop an intervention program to promote participation in daily life for patients with chronic stroke and to evaluate its efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Daily Life Promotion ProgramDaily Life Promotion Program |
| control group | Experimental | Other: general rehabilitation treatmentgeneral rehabilitation treatment |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with stroke after 6 months.
- Must be able to follow orders and no other cognition impairment, Mini Mental State Examination scale must >20.
Key exclusion criteria (5 listed)
- Clinical diagnosis of Dementia or Psychosis.
- Clinical diagnosis of Musculoskeletal disorders or Nervous system diseases.
- Patient with Congestive Heart Failure, Hypertension, Atrial fibrillation.
- Could not communication with others.
- Foreigner.
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 |
|---|---|---|
| Daily Life Promotion ProgramDaily Life Promotion Program | Other | intervention group |
| general rehabilitation treatmentgeneral rehabilitation treatment | Other | control group |
Primary outcome
Stroke Impact Scale(SIS)
Time frame: one year
quality of life measure
7 secondary outcomes
Postural Assessment Scale for Stroke patients(PASS)
Time frame: one year
Action Research Arm Test(ARAT)
Time frame: one year
Fugl-Meyer Assessment(FMA)
Time frame: one year
self-rated abilities for health practice scale
Time frame: one year
WHO Quality of Life-BREF (Taiwan version)
Time frame: one year
Taiwan Instrumental Activities of Daily Living(TIADL)
Time frame: one year
Barthel Index
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
I MING HSIAO principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Life Promotion Program and general rehabilitation treatment in people with Stroke, run by National Taiwan University 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I MING HSIAO (886-2-23123456*70420, skipbeat227@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Impact Scale(SIS) (time frame: one year). 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 16 Jun 2016.