Personalized Rehabilitation Program for Elderly Patients That Fall

NCT02862379 | Completed

• 1 other identifier: RC-P0034
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elderly; Falls; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  Change from baseline at 6 months and 12 months

• Walking and talking test

  Change from baseline at 6 months and 12 months

• Tinetti test

  Change from baseline at 6 months and 12 months

Study Arms (1)

Elderly patients that fall

EXPERIMENTAL

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

Interventions

home-based program BEHAVIORAL

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

Elderly patients that fall

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons who have fallen minimum twice the last year
• 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

You may not qualify if:

• Patients with severe disease that might interfere with walking or with program monitoring

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Esprad Chute, Ghicl

Lomme, 59462, France

Location

Study Officials

• Brigitte Romagny

  ESPRAD CHUTE, GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 11, 2016
• Study Start: October 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)