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The Effects of Fragility Fracture Integrated Rehabilitation Management

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Fragility Fracture Integrated Rehabilitation Management
Sponsored by
Zohra Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Activities of daily living, Mobility limitation, Occupational Therapy, Physical Therapy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institute of Rehabilitation MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

This refers to Fragility Fracture Integrated Rehabilitation Management

Arm Description

This refers to Fragility Fracture Integrated Rehabilitation Management and will include comprehensive rehabilitation program and assessment

Outcomes

Primary Outcome Measures

Functional Ambulatory Category (FAC)
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
EQ-5D
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.
Modified Barthel index (MBI)
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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2021
Last Updated
February 17, 2021
Sponsor
Zohra Institute of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04760756
Brief Title
The Effects of Fragility Fracture Integrated Rehabilitation Management
Official Title
The Effects of Fragility Fracture Integrated Rehabilitation Management (FIRM) of Hip Fracture in Geriatrics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zohra Institute of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Activities of daily living, Mobility limitation, Occupational Therapy, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
This refers to Fragility Fracture Integrated Rehabilitation Management
Arm Type
Experimental
Arm Description
This refers to Fragility Fracture Integrated Rehabilitation Management and will include comprehensive rehabilitation program and assessment
Intervention Type
Other
Intervention Name(s)
Fragility Fracture Integrated Rehabilitation Management
Intervention Description
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)
Primary Outcome Measure Information:
Title
Functional Ambulatory Category (FAC)
Description
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
Time Frame
2 weeks
Title
EQ-5D
Description
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.
Time Frame
2 weeks
Title
Modified Barthel index (MBI)
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients above 55 years of age, who underwent hip fracture management NIRM Pakistan due to hip fracture Patient diagnosed with femur neck, intertrochanteric fracture, and sub-trochanteric fracture Patient who got bipolar hemiarthroplasty, total hip replacement arthroplasty, reduction and internal fixation Exclusion Criteria: Patients who underwent surgery for a cause other than a hip fracture (infection, arthritis, loosening, avascular necrosis) Patients who underwent surgery because of femur shaft fracture, acetabular fracture, periprosthetic fracture pathologic fracture by tumor Isolated fracture of the greater or lesser tuberosity Multiple fracture Revision operation Patients who do not agree to participate in clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaista Habibullah, PhD
Phone
03362291027
Email
shaista.habibullah2014@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anam Aftab, Phd*
Organizational Affiliation
Riphah college of rehabilitation and allied health sciences - Rawalpindi
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Rehabilitation Medicine
City
Islamabad
ZIP/Postal Code
0042
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaista Habibullah, Phd
Phone
03362291027
Email
shaista.habibullah2014@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effects of Fragility Fracture Integrated Rehabilitation Management

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