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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01934946
Other study ID # TCHIRB-1020430
Secondary ID
Status Recruiting
Phase N/A
First received August 22, 2013
Last updated September 4, 2013
Start date September 2013
Est. completion date July 2014

Study information

Verified date September 2013
Source Taipei City Hospital
Contact MUJUNG KAO, MD
Phone 0919060998
Email woodkao35@yahoo.com.tw
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

1. more than 60 years old,

2. hip fracture s/p within 3 months,

3. potential for rehabilitation.

Exclusion Criteria:

1. Active infection, such as pneumonia, UTI, osteomyelitis, wound infection

2. 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

3. No caregiver

4. No potential for rehabilitation, such as severe dementia, poor cognition, poor cooperation and motivation, poor family support

5. ESRD on Hemodialysis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
comprehensive rehabilitation
received 14 days hospitalization for comprehensive rehabilitation
home rehabilitation
6 times home rehabilitation services within 3 months

Locations

Country Name City State
Taiwan Taipei City Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Harris Hip Score change 2 weeks , 3 months after intervention Yes
Primary Pain scale change 2 weeks and 3 months after intervention Yes
Secondary Barthel Activity of Daily Living change 2 weeks , 3 months after intervention Yes
See also
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Active, not recruiting NCT00859378 - Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures N/A