Fragility Fracture Integrated Rehabilitation Management (FIRM)

Not Applicable

• Conditions: Hip Fractures
• Interventions: Other: Conventional rehabilitation; Other: FIRM

• Registration Number: NCT03430193
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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.

1. Standardization of initial evaluation for fall and re-fracture risks before rehabilitation

2. Standardization in initial screening for prevention for common complication after fracture and early diagnosis

3. Evidence based standardization in rehabilitation after fragility fracture

4. Development for safe return to normal daily life

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-02-09
• Study Start: 2018-02-12
• Study First Posted: 2018-02-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-15
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

1. Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
2. Type of surgery : Bipolar hemiarthroplasty, THA, ORIF

Exclusion Criteria

1. Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
2. Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
3. Combined multiple fracture (ex. Upper extremity)
4. Revision operation
5. Disagree to participation for clinical trial
6. Severe cognitive dysfunction (Obey command ≤1)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	Conventional rehabilitation	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.
FIRM group	FIRM	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.

Primary Outcome Measures

Name	Time	Method
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation	0, 3 month, 6 month, 12 month	range, 0 to 5; decreasingly worse

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 SeongNam, Gyeonggi, Korea, Republic of