- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934946
Rehabilitation Care for Hip Fracture
September 4, 2013 updated by: MUJUNG KAO, Taipei City Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 111
- Recruiting
- Taipei City Hospital
-
Contact:
- MUJUNG KAO, MD
- Phone Number: 0919060998
- Email: woodkao35@yahoo.com.tw
-
Principal Investigator:
- MUJUNG KAO, MD
-
-
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
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- more than 60 years old,
- hip fracture s/p within 3 months,
- potential for rehabilitation.
Exclusion Criteria:
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: comprehensive rehabilitation 10 days
comprehensive rehabilitation PT OT once per day for 10 times within 14 days hospitalization
|
received 14 days hospitalization for comprehensive rehabilitation
|
|
Placebo Comparator: home rehabilitation
home rehabilitation 6 times of PT home visit within 3 months after discharge
|
6 times home rehabilitation services within 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scale
Time Frame: 2 weeks and 3 months after intervention
|
change
|
2 weeks and 3 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barthel Activity of Daily Living
Time Frame: 2 weeks , 3 months after intervention
|
change
|
2 weeks , 3 months after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Harris Hip Score
Time Frame: 2 weeks , 3 months after intervention
|
change
|
2 weeks , 3 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: MUJUNG KAO, MD, Taipei City Hospital
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
September 1, 2013
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
August 22, 2013
First Submitted That Met QC Criteria
August 29, 2013
First Posted (Estimate)
September 4, 2013
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCHIRB-1020430
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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