Implementation and Validation of Instrumented Stair Climb Test

NCT06999850 | Recruiting

• 1 other identifier: 106_24 (ex1134)
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stair Climbing; Instrumentation; Test

Keywords

Stair Climb Test; Cerebral Palsy; Stroke; amputee; Parkinson

Outcome Measures

Primary Outcomes (2)

• Absolue error automatic test time

  Absolute errors were calculated for the duration time of the stair ascent and descent and for each variable by taking the absolute value after subtracting the values obtained using IMU methods from the value measured using the tradional chronometer method

  Through study completion, an average of 1 year

• Intra - inter operator variability

  To ensure consistency between the data obtained by the IMU method and the data obtained by the traditional chronometric method, the investigators first calculated the normality of the data. The two-way mixed effects model, absolute agreement, and average measurements were used to calculate the ICCs between the duration time of both systems in case of normality. Instead, the Sperman test was used by the investigator if the data had a non-normal distribution

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• correlations with Ten meters Walk Test (10mWT)

  Through study completion, an average of 1 year

• correlations with 30 seconds chair to stand test

  Through study completion, an average of 1 year

• correlations with Timed Up and Go (TUG)

  Through study completion, an average of 1 year

• correlations with Borg Scale

  Through study completion, an average of 1 year

Study Arms (8)

healthy children

OTHER

This group involves healthy children aged 4-18 years old, without gait impairmets

Other: Walk Test; Other: Repaeted Instrumented Stair Climb Test

Healthy adults

OTHER

This group involves healthy adults aged 18-65 years old, without gait impairmets

Other: Walk Test; Other: Repaeted Instrumented Stair Climb Test

Healthy elderly

OTHER

This group involves healthy eleferly aged 65-85 years old, without gait impairmets

Other: Walk Test; Other: Repaeted Instrumented Stair Climb Test

CP subjects

OTHER

pediatric subjects diagnosed with Infantile Cerebral Paralysis (PCI) and clinical sign of left or right hemiparesis;

Other: Instrumented Stair Climb Test; Other: Walk Test

Leg amputee subjects

OTHER

Patients aged 19-80 years, with results of leg amputation (transtibial), who carry limb prostheses

Other: Instrumented Stair Climb Test; Other: Walk Test

Arthroplasty Subjects

OTHER

patients aged 65-80 years, with aftereffects of hip or knee arthroplasty, excluding prosthetic revision procedures

Other: Instrumented Stair Climb Test; Other: Walk Test

Parkinson Subjects

OTHER

atients aged 65-80 years, with diagnosis of Parkinson's disease or Parkinsonism even on a vascular basis

Other: Instrumented Stair Climb Test; Other: Walk Test

Stroke Subjects

OTHER

Patients aged 65-80 years, with aftereffects of Cerebral Stroke with left or right hemiparesis

Other: Instrumented Stair Climb Test; Other: Walk Test

Interventions

Repaeted Instrumented Stair Climb Test OTHER

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.

Healthy adults; Healthy elderly; healthy children

Instrumented Stair Climb Test OTHER

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;

Arthroplasty Subjects; CP subjects; Leg amputee subjects; Parkinson Subjects; Stroke Subjects

Walk Test OTHER

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

Arthroplasty Subjects; CP subjects; Healthy adults; Healthy elderly; Leg amputee subjects; Parkinson Subjects; Stroke Subjects; healthy children

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Ability to climb and descend 10 steps with supervision, even with handrail support.

You may not qualify if:

• Need for help from an operator or use of orthoses to make the stairs;
• Inability to dress the instrumentation (accelerometer/electromyograph);
• clinical condition that does not recommend the execution of scales (e.g. NYHA Class IV cardiovascular decompensation, epilepsy not controlled by drugs, serious visual disturbances...);
• inability to follow verbal instructions.
• age 4-80 years (8 subjects 4-18 years; 8 subjects 19-65 years; 8 subjects 65-80 years);
• absence of diagnosis of neurological or orthopaedic pathologies, which impair the patient's mobility.
• age range 4-18 years;
• Diagnosis of Infantile Cerebral Palsy;
• right or left hemiparesis;
• ability motor skills in levels I - III according to the GMFCS (Gross Motor Function Classification System).
• Age 65-80 years;
• postoperative postoperative hip or knee arthroplasty (in election and post-fracture, any revisions will be excluded).
• age range from 19 to 80 years;
• Leg amputation (trans-tibial), fitted with limb prosthesis.
• age range from 65 years;

Sponsors & Collaborators

• ASP Istituti Milanesi Martinitt e Stelline e Pio Albergo Trivulzio: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• IRCCS Eugenio Medea: lead
• Politecnico di Milano: collaborator

Study Sites (3)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

ASP Istituti Milanesi Martinitt e Stelline e Pio Albergo Trivulzio

Milan, Milano, 20146, Italy

RECRUITING

IRCCS Istituti Clinici Maugeri Tradate

Tradate, Varese, 21049, Italy

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Stroke

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Giovanni Pintabona, Medicine

CONTACT

+39031877836; giovanni.pintabona@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: April 4, 2025
• Primary Completion: April 4, 2026
• Study Completion: April 4, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IT (3)