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Completed

NCT Number: NCT06616402

Assessing the Usability and Reliability of the Prototype Prosthesis Devices

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.

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Key information

Conditions

Amputation Amputation, Traumatic Leg Amputation Traumatic Amputations Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Ad hoc check list for Adverse Event

    Time frame: baseline

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

  2. Ad hoc check list for Adverse Event

    Time frame: day 1

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

  3. Ad hoc check list for Adverse Event

    Time frame: day 2

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

  4. Ad hoc check list for Adverse Event

    Time frame: day 3

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

  5. Ad hoc check list for Adverse Event

    Time frame: day 4

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

  6. Ad hoc check list for Adverse Event

    Time frame: day 5

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

  7. Ad hoc check list for Adverse Event

    Time frame: day 6

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

Secondary outcomes

  1. Borg Scale

    Time frame: day 1

    0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.

  2. Borg Scale

    Time frame: day 2

    0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.

  3. Borg Scale

    Time frame: day 3

    0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.

  4. Borg Scale

    Time frame: day 4

    0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.

  5. Borg Scale

    Time frame: day 5

    0-10 numerical rating scale that evaluate of the subjective perception of efforts during walking.

  6. 10mwt - 10 meters walking test

    Time frame: baseline

    to evaluate walking capacity measured in seconds

  7. 10mwt - 10 meters walking test

    Time frame: day 4

    to evaluate walking capacity measured in seconds

  8. 6mwt - 6 minutes walking test

    Time frame: baseline

    to evaluate walking capacity measured in metres

  9. System Usability Scale

    Time frame: day 6.

    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.

  10. TUG - Time Up and Go

    Time frame: baseline

    to assess lower limb capabilities in seconds

  11. TUG - Time Up and Go

    Time frame: day 4

    to assess lower limb capabilities in seconds

  12. SCT - Stair Climbing Test

    Time frame: baseline

    to assess the capabilities of climb 8 stairs in seconds

  13. SCT - Stair Climbing Test

    Time frame: day 4

    to assess the capabilities of climb 8 stairs in seconds

  14. 6mwt - 6 minutes walking test

    Time frame: day 6

    to evaluate walking capacity measured in metres

  15. FCT - Functional Reach Test

    Time frame: baseline

    to assess the balance in centimeters

  16. Functional Reach Test

    Time frame: day 5

    to assess the balance in centimeters

  17. Cost of Transport -COT

    Time frame: day 6

    To assess metabolic consumption

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

MOTU++ - Studio Clinico Protesi

Acronym: MOTU++

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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