Stair ClimbingSCTSNCT06999850
Implementation and Validation of Instrumented Stair Climb Test
A study testing Instrumented Stair Climb Test, Walk Test and Repaeted Instrumented Stair Climb Test in people with Stair Climbing and Instrumentation, run by IRCCS Eugenio Medea at 3 sites in Italy.
Trial 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)… Read more about this study
- Who is it for?
- Ages 4 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stair Climbing, Instrumentation, Test
- What is being tested?
- Instrumented Stair Climb Test, Walk Test and Repaeted Instrumented Stair Climb Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesItaly
- Study dates
- 4 Apr 2025to 4 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Show all 15Show fewer
- 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;
- diagnosis of Parkinson's disease or Parkinsonism also on a vascular basis.
- Age 65-80 years;
- Aftereffects of Ictus Cerebri;
- left or right hemiparesis.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS E. Medea
Bosisio Parini, Lecco, 23842
Giovanni Pintabona, Medicine, 031877836, giovanni.pintabona@lanostrafamiglia.it
- Recruiting
ASP Istituti Milanesi Martinitt e Stelline e Pio Albergo Trivulzio
Milan, Milano, 20146
Calogero Malfitano, Medicine, 02-40291532, calogero.malfitano@pioalbergotrivulzio.it
- Recruiting
IRCCS Istituti Clinici Maugeri Tradate
Tradate, Varese, 21049
Francesco Negrini, Medicine, 0331-829111, francesco.negrini@icsmaugeri.it
About this study
Official title: Implementazione e Validazione di un Test Per l'Analisi Del Movimento Della Salita e Discesa Delle Scale Con Sensori Indossabili
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.
Read the 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
- Being tested
- Instrumented Stair Climb Test, Walk Test, Repaeted Instrumented Stair Climb Test
- Keywords
- Stair Climb Test, Cerebral Palsy, Stroke, amputee, Parkinson
- Medical subject headings
- Cerebral Palsy, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented Stair Climb TestOther
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;
Walk TestOther
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
Repaeted Instrumented Stair Climb TestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy children | Other | This group involves healthy children aged 4-18 years old, without gait impairmets Receives: 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 Receives: 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 Receives: 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; Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Instrumented Stair Climb Test; Other: Walk Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
correlations with Ten meters Walk Test (10mWT)
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical test of the Ten meters walking test (10mWT). In the 10mWT the total time taken to ambulate 6 meters (m) is recorded to the nearest hundredth of a second. 6 m is then divided by the total time (in seconds) taken to ambulate and recorded in m/s.
Measured: Through study completion, an average of 1 year
correlations with 30 seconds chair to stand test
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical test of the 30 seconds chair to stand test. The test score is the total number of lifts completed in 30 seconds. During the test, the participant can stop and rest if he is tired without stopping time. If a person fails to perform any high the score for the test is zero
Measured: Through study completion, an average of 1 year
correlations with Timed Up and Go (TUG)
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical test Timed Up and Go test (TuG). The score in the text corresponds to the time taken by the participants to get up, walk to a distance of 3 m, turn around and return to their seats. Regular walking aids are permitted and recorded if necessary.
Measured: Through study completion, an average of 1 year
correlations with Borg Scale
The investigators determine if there are any correlations between the instrumental data gathered from a test performed using the IMU method and the clinical Borg Scale. This is a scale to assess the intensity of exercise without having to rely on physiological parameters. The original Borg version is a scale of 6-20.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start4 Apr 2025
- Primary completion4 Apr 2026 (estimated)
- Study completion4 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stair ClimbingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, ASP Istituti Milanesi Martinitt e Stelline e Pio Albergo Trivulzio, Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999850
- Sponsor's protocol ID
- 106_24 (ex1134)
- Acronym
- SCTS
- Status last verified
- Feb 2026
- First submitted
- 22 May 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementazione e Validazione di un Test Per l'Analisi Del Movimento Della Salita e Discesa Delle Scale Con Sensori Indossabili
- ClinicalTrials.gov ID
- NCT06999850
- Acronym / sponsor ID
- SCTS / 106_24 (ex1134)
- Conditions
- Stair Climbing, Instrumentation, Test
- Keywords
- Stair Climb Test, Cerebral Palsy, Stroke, amputee, Parkinson
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Politecnico di Milano, ASP Istituti Milanesi Martinitt e Stelline e Pio Albergo Trivulzio, Istituti Clinici Scientifici Maugeri SpA
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 4 Apr 2026 (estimated)
- Study completion
- 4 Apr 2026 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| healthy children | Other | Other: Walk Test, Other: Repaeted Instrumented Stair Climb TestThis group involves healthy children aged 4-18 years old, without gait impairmets |
| Healthy adults | Other | Other: Walk Test, Other: Repaeted Instrumented Stair Climb TestThis group involves healthy adults aged 18-65 years old, without gait impairmets |
| Healthy elderly | Other | Other: Walk Test, Other: Repaeted Instrumented Stair Climb TestThis group involves healthy eleferly aged 65-85 years old, without gait impairmets |
| CP subjects | Other | Other: Instrumented Stair Climb Test, Other: Walk Testpediatric subjects diagnosed with Infantile Cerebral Paralysis (PCI) and clinical sign of left or right hemiparesis; |
| Leg amputee subjects | Other | Other: Instrumented Stair Climb Test, Other: Walk TestPatients aged 19-80 years, with results of leg amputation (transtibial), who carry limb prostheses |
| Arthroplasty Subjects | Other | Other: Instrumented Stair Climb Test, Other: Walk Testpatients aged 65-80 years, with aftereffects of hip or knee arthroplasty, excluding prosthetic revision procedures |
| Parkinson Subjects | Other | Other: Instrumented Stair Climb Test, Other: Walk Testatients aged 65-80 years, with diagnosis of Parkinson's disease or Parkinsonism even on a vascular basis |
| Stroke Subjects | Other | Other: Instrumented Stair Climb Test, Other: Walk TestPatients aged 65-80 years, with aftereffects of Cerebral Stroke with left or right hemiparesis |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrumented Stair Climb TestInstrumented 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 | Arthroplasty Subjects, CP subjects, Leg amputee subjects, Parkinson Subjects, Stroke Subjects |
| Walk TestAssessment 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 | Arthroplasty Subjects, CP subjects, Healthy adults, Healthy elderly, Leg amputee subjects, Parkinson Subjects, Stroke Subjects, healthy children |
| Repaeted Instrumented Stair Climb TestInstrumented 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. | Other | Healthy adults, Healthy elderly, healthy children |
Primary outcome
Absolue error automatic test time
Time frame: Through study completion, an average of 1 year
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
Intra - inter operator variability
Time frame: Through study completion, an average of 1 year
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
4 secondary outcomes
correlations with Ten meters Walk Test (10mWT)
Time frame: Through study completion, an average of 1 year
correlations with 30 seconds chair to stand test
Time frame: Through study completion, an average of 1 year
correlations with Timed Up and Go (TUG)
Time frame: Through study completion, an average of 1 year
correlations with Borg Scale
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumented Stair Climb Test, Walk Test and Repaeted Instrumented Stair Climb Test in people with Stair Climbing and Instrumentation, run by IRCCS Eugenio Medea at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Pintabona, Medicine (+39031877836, giovanni.pintabona@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolue error automatic test time (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.