Fall Clinical Trial
— ENCRAGEOfficial title:
Occupational Therapy Group Program on Falls Prevention and Patient Education for the Older Adults Hospitalized in Service de Soins de Suite et de Réadaptation Gériatrique (SSRG) at Hôpitaux Universitaires de Strasbourg (HUS)
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Service de Soins de Suite et de Réadaptation Gériatrique - Ergothérapie -Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
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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