NCT06999850

Implementation and Validation of Instrumented Stair Climb Test

Implementazione e Validazione di un Test Per l'Analisi Del Movimento Della Salita e Discesa Delle Scale Con Sensori Indossabili

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: All
• Age: 4 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to design an instrumented test for the evaluation of the climb of stairs. In particular, the main purpose is to characterize and compare the performance of subjects, both pediatrics and adults, with different pathologies (cerebral palsy, amputee, Parkinson's disease, stroke and arthroplasty) in carrying out the instrumented test of climbing and descending stairs. This would provide potentially useful information to complement the clinical assessment, including investigating the existence of correlations between the instrumental data obtained and the clinical scales collected. The secondary objective is to evaluate, in a first phase of the study, the feasibility and reliability of the test, analyzing the validity of the indices obtained in terms of intra- and inter-operator reliability on healthy subjects.

Detailed description

In today's clinical practice there are several assessment tools available to measure strength, endurance and balance. These tools include manual testing, standardised measurement scales or disease-specific scoring systems in which the results obtained during the performance of different motor tasks are calculated to obtain an overall score reflecting the functional level. Among the most used tests, for example, we remember the Six Minute Walking Test, in which the maximum distance walked, expressed in meters, is measured in a time of 6 minutes under standardized conditions, allowing the evaluation of muscular endurance and gait aspects. In addition to tests that monitor walking abilities, there are tests for more complex activities such as climbing and descending stairs. The ability to climb stairs, in contrast to flat walking, can be considered a more challenging task, as it places greater emphasis on muscle strength of lower limbs, requires a greater range of motion of the lower limb joints and increases the demand for posture control and balance system. In addition, falls from stairs can cause more serious injury or even death than falls on a floor. Therefore, for patients with a higher risk of falling, an objective assessment of the performance of climbing stairs could be of great interest, providing fundamental support in managing the activities of the patient's daily life. In the past, a number of methods and technologies have been proposed to analyse and quantify human gait. Measurement systems range from optoelectronic systems, pressure pads or force plates to mobile sensors worn on the body such as inertial units (IMUs) or pressure pads. Mobile gait analysis systems based on IMU, in particular, are attracting increasing interest for use in long-term assessments that can be easily performed in clinical practice. Similarly, inertial sensors could be adopted for an objective evaluation of the ascent and descent of ladders thanks to adapted step analysis algorithms capable of segmenting, parameterizing and classifying the ascent and descent of ladders. The aim of this study, therefore, is to design a test for the evaluation of climbing stairs based on the use of wearable sensors. In particular, the main objective will be to characterise and compare the performance of subjects with different pathologies, providing potentially useful information to complement clinical evaluation. The secondary objective of the study will be to analyse the reliability of the indices obtained. This work proposal is the result of collaboration between several centres: IRCCS E. Medea, IRCCS Istituti Clinici Maugeri Tradate, Pio Albergo Trivulzio and Politecnico di Milano. In particular, IRCCS E. Medea, IRCCS Istituti Clinici Maugeri Tradate and Pio Albergo Trivulzio will be responsible for the recruitment of subjects and data collection. These centres will have the support of the Politecnico di Milano for the processing of data and for the development of the algorithms necessary for the extraction of the monitored parameters from the devices used.

Conditions

• Stair Climbing
• Instrumentation
• Test

Interventions

Type	Name	Description
OTHER	Instrumented Stair Climb Test	Instrumented test of climbing and descending stairs for the evaluation of kinematic and electromyographic variables. The test consists of repeating the ascent and descent of a flight of 10-12 steps;
OTHER	Walk Test	Assessment of climbing and walking skills through test series: Borg scale: An evaluation scale for measuring effort perception. The evaluation scale consists of answering some questions at the end of the exercise described above; 10-metre walk test (10MWT): Test to assess walking speed in metres per second over a short distance. Can be used to determine functional mobility, gait and vestibular function. The test consists of walking at a steady speed and safely for 10 metres; 30 second sit to stand test: test for the evaluation of strength and endurance of the legs in the elderly. The test consists in performing the movement of standing up and sitting down from a chair for 30 consecutive seconds; Timed Up \& Go test (TUG): test to assess the risk of falling and balance. During the test, patients wear normal footwear and may use a walking aid if necessary. The patient starts in a sitting position, gets up on the therapist's command, walks in a straight line for a distance of 3 m
OTHER	Repaeted Instrumented Stair Climb Test	Instrumented test of climbing and descending stairs for the evaluation of kinematic and electromyographic variables. The test consists of repeating the ascent and descent of a flight of 10-12 steps. In this case, the ascent and descent of the stairs must be repeated two times. Between the two trial the IMU units must be repositioned.

Timeline

• Start date: 2025-04-04
• Primary completion: 2026-04-04
• Completion: 2026-04-04
• First posted: 2025-05-31
• Last updated: 2026-02-27

Locations

3 sites across 1 country: Italy