Assessing the Usability and Reliability of the Prototype Prosthesis Devices

NCT ID: NCT06616402

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-06-01

Brief Summary

The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.

Conditions

Amputation; Traumatic Amputations; Leg Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

prosthetic group performs the entire protocol with the prosthesis prototype.

Group Type: OTHER

prototype prosthetic group

Intervention Type: DEVICE

These 3 sessions will commence only upon successful completion of the prosthesis safety and reliability tests conducted in the preceding sessions.

For each module combination, a session will be conducted to assess motor performance through the acquisition of spatiotemporal parameters and energy efficiency parameters of gait. Motor performance will be evaluated using functional assessment tests and data will be recorded during the following activities:

• parallel bar walking on flat ground
• parallel bar walking on an inclined surface
• treadmill walking with a safety harness
• stair climbing/descending with a handrail
• standing up and sitting down from a chair within parallel bars At the end of each session, satisfaction questionnaires (ad hoc questionnaire) will be completed. At the end of the experiment, a usability scale for the devices (ad hoc System Usability Scale) will be completed.

Each session is expected to last approximately 2.5 hours.

Interventions

prototype prosthetic group

These 3 sessions will commence only upon successful completion of the prosthesis safety and reliability tests conducted in the preceding sessions.

For each module combination, a session will be conducted to assess motor performance through the acquisition of spatiotemporal parameters and energy efficiency parameters of gait. Motor performance will be evaluated using functional assessment tests and data will be recorded during the following activities:

• parallel bar walking on flat ground
• parallel bar walking on an inclined surface
• treadmill walking with a safety harness
• stair climbing/descending with a handrail
• standing up and sitting down from a chair within parallel bars At the end of each session, satisfaction questionnaires (ad hoc questionnaire) will be completed. At the end of the experiment, a usability scale for the devices (ad hoc System Usability Scale) will be completed.

Each session is expected to last approximately 2.5 hours.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 80 years;
• Lower limb amputation at the transfemoral or transtibial level;
• Functional medical classification: Level K3-K4 [25];
• Subjects wearing a prosthesis for at least 1 year (experienced wearers);
• Maximum body weight 100 kg.

Exclusion Criteria

• Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits.
• Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators.
• Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation.
• Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research.
• Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation.
• Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi

Florence, FI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Claudio Macchi, MD

Role: CONTACT

cmacchi@dongnocchi.it

0557393909

Facility Contacts

Claudio Macchi, MD

Role: primary

cmacchi@dongnocchi.it

0557393909

Other Identifiers

CP-PAI-02-23

Identifier Type: -

Identifier Source: org_study_id