Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.

NCT06883942 | Completed

• 1 other identifier: MOTU++ Studio Clinico Pedane
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation

Conditions

Lower Limb Amputation; Slip Perturbations; Fall Risk

Keywords

amputation; stumble; slipping; lower limb; fall risk

Outcome Measures

Primary Outcomes (1)

• algorithm validation

  Verifying the measurement performance of the trip and slip detection algorithm on prosthesis wearers

  baseline

Secondary Outcomes (1)

• data aquiring

  baseline

Study Arms (1)

Subjects with unilateral trans-femoral and/or trans-tibial amputation.

Procedure: prosthetic group performs the entire protocol with their own prosthesis; Device: Experimental Group

Interventions

prosthetic group performs the entire protocol with their own prosthesis PROCEDURE

The 1st session is the enrolment and functional evaluation one. The following 2 we test the algorithm functionality verification; one session for both platforms. The last 2 sessions are necessary to acquire prognostic markers for falls; one session for both platforms. The balance disturbance tests will take place on two platforms: * The sliding platform consists of a metal supporting structure and a wooden cover, which has a manual release mechanism that allows the activation of the tile responsible for simulating the events that occur during sliding. * The stumbling platform consists of a metal supporting structure and a wooden cover, which features an electronically activated plastic and foam tripping mechanism that simulates the sequence of events that occur during a stumble.

Subjects with unilateral trans-femoral and/or trans-tibial amputation.

Experimental Group DEVICE

The fall detection algorithm will be evaluated first. In a second step, the experimentally obtained prognostic markers of fall risk will be studied. The markers thus obtained shall be validated by comparison with markers already established in clinical practice or in the literature.

Subjects with unilateral trans-femoral and/or trans-tibial amputation.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with monolateral trans-femoral and/or trans-tibial.

You may qualify if:

• Trans-femoral or trans-tibial lower limb amputation;
• Functional medical classification: Level K3-K4;
• Subjects who have had a prosthesis for at least 1 year (experienced wearers);
• Informed consent signed by the subject

You may not qualify if:

• Significant medical comorbidities (severe neurological disease, cardiovascular disease diabetes/unstabilised hypertension, severe sensory deficits);
• Cardiac device wearers (PMK or AICD);
• Cognitive impairment (MMSE adjusted for age and schooling \<24);
• Inability or unwillingness to provide informed consent;
• Severe depressive symptomatology - Beck Depression Inventory (BDI-II \<19);
• Severe anxiety symptoms - State-Trait Anxiety Inventory (STAI-Y \<50).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Biorobotic Institute Scuola Superiore sant'Anna Pisa: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Florence, Italy, 50143, Italy

Location

Related Publications (4)

• Zhang F, D'Andrea SE, Nunnery MJ, Kay SM, Huang H. Towards design of a stumble detection system for artificial legs. IEEE Trans Neural Syst Rehabil Eng. 2011 Oct;19(5):567-77. doi: 10.1109/TNSRE.2011.2161888. Epub 2011 Aug 18.

  PMID: 21859635 RESULT

• Palumbo P, Randi P, Moscato S, Davalli A, Chiari L. Degree of Safety Against Falls Provided by 4 Different Prosthetic Knee Types in People With Transfemoral Amputation: A Retrospective Observational Study. Phys Ther. 2022 Apr 1;102(4):pzab310. doi: 10.1093/ptj/pzab310.

  PMID: 35079822 RESULT

• Hunter SW, Batchelor F, Hill KD, Hill AM, Mackintosh S, Payne M. Risk Factors for Falls in People With a Lower Limb Amputation: A Systematic Review. PM R. 2017 Feb;9(2):170-180.e1. doi: 10.1016/j.pmrj.2016.07.531. Epub 2016 Jul 30.

  PMID: 27485674 RESULT

• Miller WC, Speechley M, Deathe B. The prevalence and risk factors of falling and fear of falling among lower extremity amputees. Arch Phys Med Rehabil. 2001 Aug;82(8):1031-7. doi: 10.1053/apmr.2001.24295.

  PMID: 11494181 RESULT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 19, 2025
• Study Start: February 6, 2024
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: March 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)