Personalized Rehabilitation Program for Elderly Patients That Fall

Rehabilitation Clinical Trial

— CHUTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862379
• Other study ID #: RC-P0034
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 2021

Study information

• Verified date: March 2024
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Falls
• Rehabilitation

Intervention

Behavioral:
• home-based program
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

Locations

Country	Name	City	State
France	Esprad Chute, Ghicl	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of falls the previous year before inclusion		at baseline
Secondary	Life Space Assessment scale		Change from baseline at 6 months and 12 months
Secondary	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
Secondary	Walking and talking test		Change from baseline at 6 months and 12 months
Secondary	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
Secondary	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
Secondary	EuroQol five dimensions questionnaire (EQ-5D)	Questionnaire about quality of life	Change from baseline at 6 months and 12 months
Secondary	Incidence of falls during one year		through the study completion, an average of 12 months