Assessing the Usability and Reliability of the Prototype Prosthesis Devices

NCT06616402 | Completed

• 1 other identifier: CP-PAI-02-23
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Ad hoc check list for Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  baseline

• Ad hoc check list for Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 1

• Ad hoc check list for Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 2

• Ad hoc check list for Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 3

• Ad hoc check list for Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 4

• Ad hoc check list for Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 5

• Ad hoc check list for Adverse Event

  questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  day 6

Secondary Outcomes (17)

• Borg Scale

  day 1

• Borg Scale

  day 2

• Borg Scale

  day 3

• Borg Scale

  day 4

• Borg Scale

  day 5

Study Arms (1)

prosthetic group performs the entire protocol with the prosthesis prototype.

OTHER

Device: prototype prosthetic group

Interventions

prototype prosthetic group 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.

prosthetic group performs the entire protocol with the prosthesis prototype.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 27, 2024
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)