NCT01934946

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

August 22, 2013

Last Update Submit

September 4, 2013

Conditions

Keywords

hip fracture

Outcome Measures

Primary Outcomes (1)

  • Pain scale

    change

    2 weeks and 3 months after intervention

Secondary Outcomes (1)

  • Barthel Activity of Daily Living

    2 weeks , 3 months after intervention

Other Outcomes (1)

  • Harris Hip Score

    2 weeks , 3 months after intervention

Study Arms (2)

comprehensive rehabilitation 10 days

EXPERIMENTAL

comprehensive rehabilitation PT OT once per day for 10 times within 14 days hospitalization

Other: comprehensive rehabilitation

home rehabilitation

PLACEBO COMPARATOR

home rehabilitation 6 times of PT home visit within 3 months after discharge

Other: home rehabilitation

Interventions

received 14 days hospitalization for comprehensive rehabilitation

comprehensive rehabilitation 10 days

6 times home rehabilitation services within 3 months

home rehabilitation

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 60 years old,
  • hip fracture s/p within 3 months,
  • potential for rehabilitation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan, 111, Taiwan

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • MUJUNG KAO, MD

    Taipei City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KUNHUA HUANG, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 22, 2013

First Posted

September 4, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations