Clinical trial NCT06616402: Assessing the Usability and Reliability of the Prototype Prosthesis Devices
Official title: MOTU++ - Studio Clinico Protesi
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Traumatic Amputations
Leg Amputation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Ad hoc check list for Adverse Event
timeFrame: baseline
measure: Ad hoc check list for Adverse Event
timeFrame: day 1
measure: Ad hoc check list for Adverse Event
timeFrame: day 2
measure: Ad hoc check list for Adverse Event
timeFrame: day 3
measure: Ad hoc check list for Adverse Event
timeFrame: day 4
measure: Ad hoc check list for Adverse Event
timeFrame: day 5
measure: Ad hoc check list for Adverse Event
timeFrame: day 6
Secondary outcomes:
measure: Borg Scale
timeFrame: day 1
measure: Borg Scale
timeFrame: day 2
measure: Borg Scale
timeFrame: day 3
measure: Borg Scale
timeFrame: day 4
measure: Borg Scale
timeFrame: day 5
measure: 10mwt - 10 meters walking test
timeFrame: baseline
measure: 10mwt - 10 meters walking test
timeFrame: day 4
measure: 6mwt - 6 minutes walking test
timeFrame: baseline
measure: System Usability Scale
timeFrame: day 6.
measure: TUG - Time Up and Go
timeFrame: baseline
measure: TUG - Time Up and Go
timeFrame: day 4
measure: SCT - Stair Climbing Test
timeFrame: baseline
measure: SCT - Stair Climbing Test
timeFrame: day 4
measure: 6mwt - 6 minutes walking test
timeFrame: day 6
measure: FCT - Functional Reach Test
timeFrame: baseline
measure: Functional Reach Test
timeFrame: day 5
measure: Cost of Transport -COT
timeFrame: day 6
Other outcomes:
Locations:
city: Florence
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
state: FI
Study officials:
References: