NCT02512094

Brief Summary

Since an increasing in population age, there was an increasing in geriatric patients. Most of elderly patients needed rehabilitation programs to regain their quality of life during their medical treatments. Barthel index is a functional measurement to evaluate rehabilitation improvement in chronically-ill patients and also used for evaluation of patient's self-care. Barthel index had been translated into many languages and validated in many medical conditions such as spinal cord injury, congestive heart failure, pneumonia, etc. However, Barthel index had not been translated into Thai language and validated to use in hip fracture patients. The purposes of this study were to translate the Barthel index into Thai language and to assess validity and reliability of Thai version Barthel index in hip fracture patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 22, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

July 26, 2015

Results QC Date

May 1, 2017

Last Update Submit

February 19, 2018

Conditions

Keywords

Barthel indexHip fractureValidityReliability

Outcome Measures

Primary Outcomes (1)

  • Score of the Barthel Index

    Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome). Score was reported as mean score of the Barthel Index.

    up to 1 month

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hip fractured patients

You may qualify if:

  • Age at least 50 years old
  • Hip fractures within 2 weeks since injury

You may not qualify if:

  • incommunicable patients
  • pathological fractures
  • multiple fractures or multiple trauma
  • postoperative complications which change postoperative rehabilitation protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hip FracturesFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Results Point of Contact

Title
Panai Laohaprasitiporn
Organization
Faculty of Medicine Siriraj Hospital, Mahidol University

Study Officials

  • Aasis Unnanuntana, M.D.

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2015

First Posted

July 30, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 22, 2018

Results First Posted

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations