Back to resultsRehabilitation Care for Hip Fracture
Primary Purpose
Hip Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
comprehensive rehabilitation
home rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring hip fracture
Eligibility Criteria
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
Sites / Locations
- Taipei City HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
comprehensive rehabilitation 10 days
home rehabilitation
Arm Description
comprehensive rehabilitation PT OT once per day for 10 times within 14 days hospitalization
home rehabilitation 6 times of PT home visit within 3 months after discharge
Outcomes
Primary Outcome Measures
Pain scale
change
Secondary Outcome Measures
Barthel Activity of Daily Living
change
Full Information
NCT ID
NCT01934946
First Posted
August 22, 2013
Last Updated
September 4, 2013
Sponsor
Taipei City Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01934946
Brief Title
Rehabilitation Care for Hip Fracture
Official Title
Effectiveness of Post Acute Rehabilitation Care for Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei City Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
hip fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
comprehensive rehabilitation 10 days
Arm Type
Experimental
Arm Description
comprehensive rehabilitation PT OT once per day for 10 times within 14 days hospitalization
Arm Title
home rehabilitation
Arm Type
Placebo Comparator
Arm Description
home rehabilitation 6 times of PT home visit within 3 months after discharge
Intervention Type
Other
Intervention Name(s)
comprehensive rehabilitation
Intervention Description
received 14 days hospitalization for comprehensive rehabilitation
Intervention Type
Other
Intervention Name(s)
home rehabilitation
Intervention Description
6 times home rehabilitation services within 3 months
Primary Outcome Measure Information:
Title
Pain scale
Description
change
Time Frame
2 weeks and 3 months after intervention
Secondary Outcome Measure Information:
Title
Barthel Activity of Daily Living
Description
change
Time Frame
2 weeks , 3 months after intervention
Other Pre-specified Outcome Measures:
Title
Harris Hip Score
Description
change
Time Frame
2 weeks , 3 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MUJUNG KAO, MD
Phone
0919060998
Email
woodkao35@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
KUNHUA HUANG, BS
Phone
0979309125
Email
A2785@tpech.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MUJUNG KAO, MD
Organizational Affiliation
Taipei City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MUJUNG KAO, MD
Phone
0919060998
Email
woodkao35@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
MUJUNG KAO, MD
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation Care for Hip Fracture
We'll reach out to this number within 24 hrs