Clinical trial NCT05879315: Evaluation of Balance and Movement in Order to Prevent the Risk of Falling in the Post-operative Period
Official title: Stratification of Fall Risk in a Rehabilitation Department Through Tools That Evaluate Postural Balance and Movement Capacity in the Preoperative Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Fall
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Test UP and GO. The time of performance is measured in seconds and lower values indicate better balance control and lower fall risk.
timeFrame: Just Baseline
measure: Four Square Step Test. The time of performance is measured in seconds
timeFrame: Just Baseline
measure: Barthel Index. It is a questionnaire
timeFrame: Just Baseline
measure: Cumulative Illness Rating Scale. The scale has a cumulative score, which can range from 0 to 56
timeFrame: Just Baseline
measure: Stabilometric Test
timeFrame: Just Baseline
measure: Morse Scale. It is a questionnaire.
timeFrame: Just Baseline
measure: International classification of functioning, disability and health
timeFrame: Just Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bagheria
country: Italy
facility: Rizzoli Orthopedic Institute
state: Palermo
Study officials:
affiliation: Rizzoli Orthopedic Institute
name: serena rizzo
role: PRINCIPAL_INVESTIGATOR
References: