Evaluation of Balance and Movement in Order to Prevent the Risk of Falling in the Post-operative Period

Patient Fall Clinical Trial

— NOCADINRIAB  

Official title:

Stratification of Fall Risk in a Rehabilitation Department Through Tools That Evaluate Postural Balance and Movement Capacity in the Preoperative Period

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879315
• Other study ID #: CE AVEC: 888/2022/Sper/IOR
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: rizzo
• Phone: +30919297083
• Email: serena.rizzo[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to identify, in patients undergoing hip and knee joint replacement, the functional evaluation tools predictive of the risk of falling upon admission to the orthopedic department and to correlate the results obtained with clinical evaluation scales that are generally used for fall risk stratification and the number of falls actually occurring both in the orthopedic department and in the rehabilitation department.

Description:

The goal of this prospective interventional cohort study is to identify functional assessment tools predictive of the risk of falling in patients undergoing hip and knee joint replacement surgery upon admission to an orthopedic department and to correlate the results obtained with the clinical rating scales generally used for the risk stratification of fall. All patients upon admission to the Orthopedic Department of the DRS (Rizzoli Sicily Department), throughin the pre-operative setting will undergo an assessment of mobility level, dynamic stability and co-ordination: Test UP and GO, Il Four Square Step Test, Stabilometric Analysis. After admission to the DRS Rehabilitation Medicine Department, all patients will receive an evaluation, which is currently used, consisting of: History of fall risk through multidimensional assessment, Compilation of ICF(International Classification of Functioning, Disability and Health) and Barthel Index. The following ratings will also be added: Compiling the Morse scale, Pharmacological history, CIRS (Cumulative Illness Rating Scale), The scores obtained from the various measures used in the patients will be correlated to any falls recorded during hospitalization with the aim to obtain a stratification of falls risk in those patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• The patient's ability to perform the required tests, the understanding of the language of the study
• Patients of both sexes between the ages of 50 and 85;
• Patients candidates for hip and knee joint replacement in the Orthopedic Department of the DRS.

Exclusion Criteria:

• Non-ambulatory patients, patients with amputation of one of the 2 lower limbs,
• Serious neurological and/or psychiatric diseases
• Patients with vestibular deficits

Related Conditions & MeSH terms

• Patient Fall

Intervention

Other:
• Fall risk prevention in hospital
All patients (hip and knee) upon admission to the Orthopedic Department of the DRS (Rizzoli Sicily Department), throughin the pre-operative setting will undergo an assessment of mobility level, dynamic stability and co-ordination: Test UP and GO, Il Four Square Step Test, Stabilometric Analysis. After admission to the DRS Rehabilitation Medicine Department, hip and knee will receive an evaluation, which is currently used, consisting of: History of fall risk through multidimensional assessment, Compilation of ICF(International Classification of Functioning, Disability and Health) and Barthel Index. The following ratings will also be added: Compiling the Morse scale, Pharmacological history, CIRS (Cumulative Illness Rating Scale)

Locations

Country	Name	City	State
Italy	Rizzoli Orthopedic Institute	Bagheria	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test UP and GO. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk.	Participants have been instructed to get up from a chair, walk up to a sign marked on the floor 3 meter ahead on the chair, turn around in their own circles, walk up to the chair and sit down. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk.	Just Baseline
Primary	Four Square Step Test. The time of performance is measured in seconds	This test evaluates the dynamic balance of patients. The test involves the execution of a pre-established series of steps (forward, lateral, backward) within four squares. The time taken to complete one clockwise and one counterclockwise revolution is taken as a reference parameter.; The 15-second threshold helps us assess the risk of falling in the population being studied.; Times longer than 15 seconds are associated with a higher risk of falling. The young population is around 6-7 seconds.	Just Baseline
Primary	Barthel Index. It is a questionnaire	The index, has it to establish the patient's degree of independence. It is made up of 10 items that include the municipalities daily activities (ADL Activities of Daily Living). Each item is assigned a score, the sum (maximum 100) indicates the degree of autonomy of the patient in carrying out the activities of daily life, the higher the score, the greater the autonomy of the subject.	Just Baseline
Primary	Cumulative Illness Rating Scale. The scale has a cumulative score, which can range from 0 to 56	It is a standardized tool used in the medical field to measure the patient's health as objectively as possible. The tool is clinical in nature and requires the physician to evaluate and measure the clinical and functional severity of 14 categories of disease. For each of these pathologies a severity value must be defined, based on the clinical history, the physical examination and the symptoms declared by the patient. The scale has a cumulative score, which can range from 0 to 56. According to its developers, the maximum score is not compatible with the patient's life.	Just Baseline
Primary	Stabilometric Test	The posturographic analysis has been led by stabilometric platform. The partecipations underwent a static analysis (stabilometric examina-tion) maintaining standing position with feet placed together with an angle of 30 grades between right and left heels at 2 cm of distance, firstly with open eyes for 51.2 seconds and after that with closed eyes for 51.2 seconds too, in order to analyse the time and frequency of oscillations and self-adjustments of the patient excluding the visual input.	Just Baseline
Primary	Morse Scale. It is a questionnaire.	The Morse scale is a quick and easy way to assess a patient's likelihood of falling. The questions in the questionnaire should be addressed to the patient or, if there are physical and cognitive problems that prevent him from responding to a family member. It is a scale composed of 6 items: (i) history of falls, (ii) presence of pathologies at risk, (iii) outpatient aids, (iv) intravenous therapy, (v) type of gait and (vi) mental state". Each answer has a score.; The sum of the scores obtained defines the risk of falling: 0 to 24 = low risk 25 to 50 = medium risk equal to or > 51 = high risk	Just Baseline
Primary	International classification of functioning, disability and health	The general function of the ICF classification is to provide a standard and unified language that serves as a reference model for the description of health and related states. It defines the components of health and some related components such as education and Work.; The domains (= a practical and meaningful set of physiological functions, anatomical structures, actions, tasks, or related life areas) contained in the ICF can, therefore, be seen as domains of the health and related domains. These domains are described from a bodily, individual and social point of view in two lists main: Body functions and structures; Activities and Participation; The ICF is therefore no longer a classification of diseases (1980 version) but has instead become one classification of components of health.	Just Baseline