NCT06999850 Implementation and Validation of Instrumented Stair Climb Test
| NCT ID | NCT06999850 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Stair Climbing |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-04-04 |
| Primary Completion | 2026-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2025-04-04 with a primary completion date of 2026-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06999850 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 80 Years, studying Stair Climbing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06999850 currently recruiting?
Yes, NCT06999850 is actively recruiting participants. Contact the research team at giovanni.pintabona@lanostrafamiglia.it for enrollment information.
Where is the NCT06999850 trial being conducted?
This trial is being conducted at Bosisio Parini, Italy, Milan, Italy, Tradate, Italy.
Who is sponsoring the NCT06999850 clinical trial?
NCT06999850 is sponsored by IRCCS Eugenio Medea. The trial plans to enroll 64 participants.