The Effects of Fragility Fracture Integrated Rehabilitation Management

February 17, 2021 updated by: Aftab, Zohra Institute of Health Sciences

The Effects of Fragility Fracture Integrated Rehabilitation Management (FIRM) of Hip Fracture in Geriatrics

• To determine the effects of Fragility Fracture Integrated Rehabilitation Management approach in geriatric hip fracture patients (post surgical)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This refers to Fragility Fracture Integrated Rehabilitation Management and will include following comprehensive rehabilitation program including rehab specialist, physiotherapist, occupational therapist and rehab nurse.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients above 55 years of age, who underwent hip fracture management NIRM Pakistan due to hip fracture
  2. Patient diagnosed with femur neck, intertrochanteric fracture, and sub-trochanteric fracture
  3. Patient who got bipolar hemiarthroplasty, total hip replacement arthroplasty, reduction and internal fixation

Exclusion Criteria:

  1. Patients who underwent surgery for a cause other than a hip fracture (infection, arthritis, loosening, avascular necrosis)
  2. Patients who underwent surgery because of femur shaft fracture, acetabular fracture, periprosthetic fracture pathologic fracture by tumor
  3. Isolated fracture of the greater or lesser tuberosity
  4. Multiple fracture
  5. Revision operation
  6. Patients who do not agree to participate in clinical trials

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: This refers to Fragility Fracture Integrated Rehabilitation Management
This refers to Fragility Fracture Integrated Rehabilitation Management and will include comprehensive rehabilitation program and assessment
Other: Fragility Fracture Integrated Rehabilitation Management
  • At least 2 hours of rehabilitation management per day
  • Including occupational therapy (training to improve daily life performance)
  • Inpatient (the first 2 weeks): daily management (body control ability, mobility ability, hygiene management, etc.)
  • Outpatient (2-6 weeks): management once a week
  • The management period is for 2 weeks (1 week after surgery)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulatory Category (FAC)
Time Frame: 2 weeks
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device
2 weeks
EQ-5D
Time Frame: 2 weeks
EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
2 weeks
Modified Barthel index (MBI)
Time Frame: 2 weeks
Modified Barthel ADL index Measure of physical disability used widely to assess behaviour relating to activities of daily living for patients with disabling conditions. It measures what patients do in practice.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zohra Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 15, 2019

Primary Completion (Anticipated)

July 20, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/0045 Anam Aftab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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