Hip FractureNCT01934946
Rehabilitation Care for Hip Fracture
A study testing comprehensive rehabilitation and home rehabilitation in people with Hip Fracture, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no adequate rehabilitation was given. The aim of the study is to compare the effectiveness of different types of post acute rehabilitation care for hip fracture. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- comprehensive rehabilitation and home rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Jul 2014
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 60 years old,
- hip fracture s/p within 3 months,
- potential for rehabilitation.
Who cannot join
- Active infection, such as pneumonia, UTI, osteomyelitis, wound infection
- Other uncontrolled medical condition, such as, dyspnea on exertion, acute renal failure, acute coronary syndrome, acute heart failure, uncontrolled diabetes, active malignancy, DVT, possibility of pulmonary embolism, acute psychosis
- No caregiver
- No potential for rehabilitation, such as severe dementia, poor cognition, poor cooperation and motivation, poor family support
- ESRD on Hemodialysis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital
Taipei, Taiwan, 111
MUJUNG KAO, MD, 0919060998, woodkao35@yahoo.com.tw
MUJUNG KAO, MD
About this study
Official title: Effectiveness of Post Acute Rehabilitation Care for Hip Fracture
Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no adequate rehabilitation was given. The aim of the study is to compare the effectiveness of different types of post acute rehabilitation care for hip fracture.
Read the detailed description
Method: This study will recruit 150 peoples with hip fracture from hospitals in Taipei from Jan 1, 2014 to Dec 31, 2014. The subjects from wards are randomly divided into group A, B and Group C. Each group includes 50 cases of hip fracture. Group C received 14 days hospitalization for comprehensive rehabilitation and 6 times home rehabilitation services within 3 months; Group B received 14 days hospitalization for comprehensive rehabilitation and Group A was control group.
- Conditions
- Hip Fracture
- Being tested
- comprehensive rehabilitation, home rehabilitation
- Keywords
- hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive rehabilitationOther
received 14 days hospitalization for comprehensive rehabilitation
home rehabilitationOther
6 times home rehabilitation services within 3 months
| Study group | Role | What they receive |
|---|---|---|
| comprehensive rehabilitation 10 days | Experimental | comprehensive rehabilitation PT OT once per day for 10 times within 14 days hospitalization Receives: Other: comprehensive rehabilitation |
| home rehabilitation | Placebo comparator | home rehabilitation 6 times of PT home visit within 3 months after discharge Receives: Other: home rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
change
Measured: 2 weeks and 3 months after intervention
Secondary outcomes (1)
Barthel Activity of Daily Living
change
Measured: 2 weeks , 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MUJUNG KAO, Taipei City Hospital
- Investigators
- MUJUNG KAO, MD, Principal investigator, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934946
- Sponsor's protocol ID
- TCHIRB-1020430
- Status last verified
- Sep 2013
- First submitted
- 22 Aug 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Post Acute Rehabilitation Care for Hip Fracture
- ClinicalTrials.gov ID
- NCT01934946
- Acronym / sponsor ID
- TCHIRB-1020430
- Conditions
- Hip Fracture
- Keywords
- hip fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 4 Sep 2013 (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.
Purpose: Hip fracture is a common disease on elderly. They become disabled easily if no adequate rehabilitation was given. The aim of the study is to compare the effectiveness of different types of post acute rehabilitation care for hip fracture.
Detailed description
Method: This study will recruit 150 peoples with hip fracture from hospitals in Taipei from Jan 1, 2014 to Dec 31, 2014. The subjects from wards are randomly divided into group A, B and Group C. Each group includes 50 cases of hip fracture. Group C received 14 days hospitalization for comprehensive rehabilitation and 6 times home rehabilitation services within 3 months; Group B received 14 days hospitalization for comprehensive rehabilitation and Group A was control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comprehensive rehabilitation 10 days | Experimental | Other: comprehensive rehabilitationcomprehensive rehabilitation PT OT once per day for 10 times within 14 days hospitalization |
| home rehabilitation | Placebo comparator | Other: home rehabilitationhome rehabilitation 6 times of PT home visit within 3 months after discharge |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- more than 60 years old,
- hip fracture s/p within 3 months,
- potential for rehabilitation.
Key exclusion criteria (5 listed)
- Active infection, such as pneumonia, UTI, osteomyelitis, wound infection
- Other uncontrolled medical condition, such as, dyspnea on exertion, acute renal failure, acute coronary syndrome, acute heart failure, uncontrolled diabetes, active malignancy, DVT, possibility of pulmonary embolism, acute psychosis
- No caregiver
- No potential for rehabilitation, such as severe dementia, poor cognition, poor cooperation and motivation, poor family support
- ESRD on Hemodialysis
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 |
|---|---|---|
| comprehensive rehabilitationreceived 14 days hospitalization for comprehensive rehabilitation | Other | comprehensive rehabilitation 10 days |
| home rehabilitation6 times home rehabilitation services within 3 months | Other | home rehabilitation |
Primary outcome
Pain scale
Time frame: 2 weeks and 3 months after intervention
change
1 secondary outcome
Barthel Activity of Daily Living
Time frame: 2 weeks , 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
MUJUNG KAO, MD principal investigator
Taipei City 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 comprehensive rehabilitation and home rehabilitation in people with Hip Fracture, run by Taipei City 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 3 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 5 Sep 2013. 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. Some participants in this study may receive a placebo. 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 MUJUNG KAO, MD (0919060998, woodkao35@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: 2 weeks and 3 months after intervention). 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 5 Sep 2013.