Personalized Rehabilitation Program for Elderly Patients That Fall

Study Overview
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Brief Summary
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The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death. The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

Official Title
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Evaluation of a Personalized Rehabilitation Program for Elderly Patients That Fall : Impact on the Fear of Falling

Conditions
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Elderly, Falls, Rehabilitation

Intervention / Treatment
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* Behavioral: home-based program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons who have fallen minimum twice the last year 60 years old or more Mini Mental State Examination (MMSE) equal or superior to 23/30 Persons who gave consent to participate in the study Persons with severe visual or hearing impairment Exclusion Criteria: Patients with severe disease that might interfere with walking or with program monitoring

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly patients that fall<br>Personalized rehabilitation program for elderly patients that fall for the first time. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors. | Behavioral: home-based program<br>* The objective of the rehabilitation program is to reduce the risk of falls after management of the risk factors identified. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls Efficacy Scale (FES-I) | The FES is a 10-item validated questionnaire that can be self-administered or completed during an interview. The person is asked to indicate on a 10-level rating scale his/her level of confidence in his/her capacity to accomplish a variety of activities of daily life (e.g., going up and down the stairs, taking a bath or shower) without falling. A FES score is calculated by adding up the score of each item. | Change from baseline at 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of falls the previous year before inclusion |  | at baseline | 
| Life Space Assessment scale |  | Change from baseline at 6 months and 12 months | 
| Get up and go test | It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require | Change from baseline at 6 months and 12 months | 
| Walking and talking test |  | Change from baseline at 6 months and 12 months | 
| Tinetti test | It is a clinical test for assessing a person's static and dynamic balance abilities | Change from baseline at 6 months and 12 months | 
| Measure of the time that the patient is able to stay in station bipedal standing feet together followed by a monopodal support |  | Change from baseline at 6 months and 12 months | 
| EuroQol five dimensions questionnaire (EQ-5D) | Questionnaire about quality of life | Change from baseline at 6 months and 12 months | 
| Incidence of falls during one year |  | through the study completion, an average of 12 months |