Fragility Fracture Integrated Rehabilitation Management (FIRM)

Study Overview
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Brief Summary
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A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.

Detailed Description
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The purpose of this prospective study To develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures. Standardization of initial evaluation for fall and re-fracture risks before rehabilitation Standardization in initial screening for prevention for common complication after fracture and early diagnosis Evidence based standardization in rehabilitation after fragility fracture Development for safe return to normal daily life

Official Title
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Comparative Effectiveness Research of Rehabilitation Methods and Prevention of Refracture After Fractures in Elderly Patients

Conditions
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Hip Fractures

Intervention / Treatment
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* Other: FIRM
* Other: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture Type of surgery : Bipolar hemiarthroplasty, THA, ORIF Exclusion Criteria: Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor Combined multiple fracture (ex. Upper extremity) Revision operation Disagree to participation for clinical trial Severe cognitive dysfunction (Obey command ≤1)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIRM group<br>FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided. | Other: FIRM<br>* FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward. PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided.<br>|
| Active Comparator: Conventional group<br>Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day. | Other: Conventional rehabilitation<br>* Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.<br>|
| No Intervention: No-rehabilitation group<br>Discharged patients not transferred to rehabilitation unit after surgery for hip fracture. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation | range, 0 to 5; decreasingly worse | 0, 3 month, 6 month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baselines mobility status (KOVAL) after rehabilitation | range, 1 to 7; increasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation | range, 1 to 7; decreasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation | range, 0 to 56; decreasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation | range, 0 to 30; decreasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation | range, 0 to 30 ; increasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation | range, 0 to 1; decreasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation | range, 0 to 100; decreasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation | range, 0 to 3; increasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation | range, 0 to 5; increasingly worse | 0, 3 month, 6 month, 12 month | 
| Change from baselines hand grip strength after rehabilitation | measured by a a digital dynamometer (TKK 5401 Grip-D; Takei, Niigata, Japan) | 0, 3 month, 6 month, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, multi-disciplinary rehabilitation, clinical pathway, Fragility