Assessing the Usability and Reliability of the Prototype Prosthesis Devices (MOTU++)

MOTU++ - Studio Clinico Protesi

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.

Study Overview

• Status: Completed
• Conditions: Amputation; Traumatic Amputations; Leg Amputation
• Intervention / Treatment: Device: prototype prosthetic group

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • FI
    • Florence, FI, Italy, 50143
      • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: prosthetic group performs the entire protocol with the prosthesis prototype.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borg Scale	0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.	day 1
Borg Scale	0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.	day 2
Borg Scale	0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.	day 3
Borg Scale	0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.	day 4
Borg Scale	0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.	day 5
10mwt - 10 meters walking test	to evaluate walking capacity measured in seconds	baseline
10mwt - 10 meters walking test	to evaluate walking capacity measured in seconds	day 4
6mwt - 6 minutes walking test	to evaluate walking capacity measured in metres	baseline
System Usability Scale	a questionnaire made up of 10 questions whose answers are yes structured on a Likert scale with 0-100 that assesses the usability of the prosthesis.	day 6.
TUG - Time Up and Go	to assess lower limb capabilities in seconds	baseline
TUG - Time Up and Go	to assess lower limb capabilities in seconds	day 4
SCT - Stair Climbing Test	to assess the capabilities of climb 8 stairs in seconds	baseline
SCT - Stair Climbing Test	to assess the capabilities of climb 8 stairs in seconds	day 4
6mwt - 6 minutes walking test	to evaluate walking capacity measured in metres	day 6
FCT - Functional Reach Test	to assess the balance in centimeters	baseline
Functional Reach Test	to assess the balance in centimeters	day 5
Cost of Transport -COT	To assess metabolic consumption	day 6

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: CP-PAI-02-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No