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Fragility Fracture Integrated Rehabilitation Management (FIRM)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03430193
Acronym
FIRM
Enrollment
288
Registered
2018-02-12
Start date
2018-02-12
Completion date
2021-09-30
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

rehabilitation, multi-disciplinary rehabilitation, clinical pathway, Fragility

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

Interventions

OTHERFIRM

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.

OTHERConventional 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.

Sponsors

Korea Health Industry Development Institute
CollaboratorOTHER_GOV
Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change from baselines mobility status (Functional Ambulatory Category (FAC)) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 5; decreasingly worse

Secondary

MeasureTime frameDescription
Change from baselines mobility status (KOVAL) after rehabilitation0, 3 month, 6 month, 12 monthrange, 1 to 7; increasingly worse
Change from baselines mobility status (Functional Independence Measure (FIM)- locomotion) after rehabilitation0, 3 month, 6 month, 12 monthrange, 1 to 7; decreasingly worse
Change from baselines balance and fall risk (Berg Balance Scale (BBS)) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 56; decreasingly worse
Change from baselines from cognition (Korean Mini-Mental State Examination (K-MMSE)) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 30; decreasingly worse
Change from baselines from mood (Korean version of the Geriatric Depression Scale (GDS)) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 30 ; increasingly worse
Change from baselines frailty (Korean version of fatigue, resistance, ambulation, illnesses, and loss of weight (FRAIL) scale) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 5; increasingly worse
Change from baselines hand grip strength after rehabilitation0, 3 month, 6 month, 12 monthmeasured by a a digital dynamometer (TKK 5401 Grip-D; Takei, Niigata, Japan)
Change from baselines Quality of life (Euro Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D)) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 1; decreasingly worse
Change from baselines from activities of daily life (Korean modified Barthel index (K-MBI)) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 100; decreasingly worse
Change from baselines from activities of daily life (Korean instrumental ADL (K-IADL)) after rehabilitation0, 3 month, 6 month, 12 monthrange, 0 to 3; increasingly worse

Other

MeasureTime frameDescription
Mortality0, 3 month, 6 month, 12 monthMortality rate from number of dead patients among enrolled for the study
Recovery to premorbid ambulatory status0, 3 month, 6 month, 12 monthComparison premorbid ambulatory status with post-rehabilitation ambulatory status at each follow-up period

Countries

South Korea

Contacts

Primary ContactSeung-Kyu Lim, MD
flyingmango77@gmail.com+821096045700
Backup ContactBo-Ram KIM
bboram2@gmail.com+82317877732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026