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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03738709
Other study ID # 6790
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2018
Est. completion date June 2022

Study information

Verified date December 2018
Source University Hospital, Strasbourg, France
Contact Stéphanie BETTINELLI
Phone (0)3 88 11 55 51
Email stephanie.bettinelli@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary outcome is to assess the impact of the group program on falls prevention and patient education on home modifications and the implementation of technical assistance.

This study aims to demonstrate that a group program on falls prevention and patient education will improve the acceptance and the implementation of recommendations on technical assistance and home modifications following discharge after an hospitalization for fall.

The secondary outcome will measure the impact of the group program on the incidence of falls, the number of readmissions, fear of another fall and improvement in walking and balance skills.


Recruitment information / eligibility

Status Recruiting
Enrollment 136
Est. completion date June 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Male/Female over 70 years old living at home and not in a nursing home, hospitalized after a fall or for a falls evaluation.

- Mini mental state examination score over or even 20/30.

- The person is planning to return home after discharge.

Exclusion Criteria:

- Decompensated medical pathologies.

- Severe chronical diseases with symptoms that are not stabilized by medical or non-medical treatments.

- Dizziness/vertigo linked to a vestibular or cerebellar disorder.

- Sensory disability preventing communication and participation in the group.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Falls prevention and education giving a demonstration of the usage of technical assistance.
Ecological trail to work on balance and walking. Technical assistance presentation and try-outs within the therapeutic apartment. Discussion on the perceived feelings over the exercises and the technical assistance submitted. Falls Education and prevention, screening of the dangerous activities and education on the safe behaviours.

Locations

Country Name City State
France Service de Soins de Suite et de Réadaptation Gériatrique - Ergothérapie -Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization. 1 month after hospitalization discharge (patient call #1)
Secondary Number of technical assistance and home modifications implemented following discharge in both groups, in regard to the number of recommendations given during the hospitalization. 6 months after hospitalization discharge (patient call #2)
Secondary Number of falls followed or not by an hospitalization since the discharge. The number of potential falls in the 6 months after discharge will be measured by a telephone call to the patient (if impossible, the call will be placed to his caregiver or nurse). 6 months after the hospitalization discharge (patient call #2)
Secondary Fear of falling rate Fear of falling will be measured by the Falls Efficacy Scale I [FES-I] (score from 16 to 64; higher values represent a stronger fear of falling) At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Secondary Evaluation of balance skills in daily living activities Balance skills will be measured by the "Equilibre et Vie Quotidienne" scale: scored from 6 (no danger) to 24 (high risk of fall with impossibility to realize the activities) At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Secondary Evaluation of the walking by the "Stop Walking when Talking" test Positive test (pathological) if the subject stops walking when the therapist introduces a conversation At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Secondary Evaluation of the motor skills by the Minimum Motor Test 20 items distributed in 4 themes: mobility in decubitus, sitting position, standing position, walking.
Each item rated from 0 (motor skill abnormal) to 1 (motor skill preserved) Total score from 0 to 20; higher values represent preserved motor skills
At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Secondary Evaluation of the walking speed by the Timed Up and Go test. The time of the course (in seconds) is retained as the final score. The test is positive if the score is 14 seconds or more, representing a risk of falling. At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
Secondary Evaluation of the number of footsteps in a 10 meters walk, by the Walk test on 10 meters. The score corresponds to the number of footsteps performed by the subject. Pathological score from 13 footsteps. At inclusion visit (visit 0; before the occupational therapy) and after the occupational therapy (visit 1; 2 weeks later)
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