Instrumented stair climb and descent test for people with mobility impairments

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

This project tests a wearable sensor version of the stair climb and descent test for children and adults with conditions like cerebral palsy, stroke, Parkinson's, amputations, or recent joint replacement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 4 Years to 80 Years
• Sex: All
• Sponsor: IRCCS Eugenio Medea (Academic / other)
• Locations: 3 sites (Bosisio Parini, Lecco and 2 other locations)
• Trial ID: NCT06999850 on ClinicalTrials.gov

What this trial studies

The protocol uses wearable sensors (accelerometers and surface electromyography) while participants climb and descend a standardized set of stairs to capture timing, kinematics, and muscle activity. Researchers will compare sensor-derived indices across groups (healthy controls, cerebral palsy, stroke, Parkinson's, amputees, arthroplasty) and explore correlations with clinical scales. A first phase focuses on feasibility and on intra- and inter-operator reliability in healthy subjects, with repeated instrumented stair climbs and a walk test as complementary measures. Data will be used to refine objective indices that could complement routine clinical assessments of strength, balance, and fall risk.

Who should consider this trial

Good fit: Ideal candidates are people aged roughly 4–80 who can climb and descend 10 steps with supervision (including children with hemiparetic cerebral palsy, adults with stroke or Parkinson's, amputees, and those after joint replacement).

Not a fit: Patients who cannot safely climb 10 steps, require operator help or orthoses to use stairs, cannot tolerate or wear the sensors, or have unstable/contraindicating medical conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could give clinicians objective and reliable measurements of stair-climbing ability to guide rehabilitation plans and better identify fall risk.

How similar studies have performed: Prior studies using wearable accelerometers and EMG for gait and stair analysis have shown promising correlations with clinical measures, but fully standardized and validated instrumented stair-climb protocols remain limited.

Eligibility criteria

Common inclusion criteria for all groups:

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

Common exclusion criteria for all groups:

* 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.

Inclusion criteria for the healthy group :

* 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.

Inclusion criteria for the PCI group :

* 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).

Inclusion criteria for the Orthopaedic group:

* Age 65-80 years;
* postoperative postoperative hip or knee arthroplasty (in election and post-fracture, any revisions will be excluded).

Inclusion criteria for the Amputee group:

* age range from 19 to 80 years;
* Leg amputation (trans-tibial), fitted with limb prosthesis.

Inclusion criteria for the Parkinson's group:

* age range from 65 years;
* diagnosis of Parkinson's disease or Parkinsonism also on a vascular basis.

Inclusion criteria for the group Ictus Cerebri:

* Age 65-80 years;
* Aftereffects of Ictus Cerebri;
* left or right hemiparesis.

Where this trial is running

Bosisio Parini, Lecco and 2 other locations

• IRCCS E. Medea — Bosisio Parini, Lecco, Italy (Recruiting)
• ASP Istituti Milanesi Martinitt e Stelline e Pio Albergo Trivulzio — Milan, Milano, Italy (Recruiting)
• IRCCS Istituti Clinici Maugeri Tradate — Tradate, Varese, Italy (Recruiting)

Study contacts

• Study coordinator: Giovanni Pintabona, Medicine

Conditions Stair Climbing; Instrumentation; Test; Stair Climb Test; Cerebral Palsy; Stroke; amputee; Parkinson