Clinical trial NCT06522646: Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
Official title: Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Lower Limb Amputation Above Knee (Injury)
Lead sponsor: Institution Nationale des Invalides
Sponsor class: OTHER
Collaborators: name: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
name: Hopital d'instruction des armées Percy (HIA Percy)
name: Proteor Group
name: Direction Générale de l'Armement
First posted: 2024-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to compare the adaptation capabilities of the microprocessor-controlled knee-ankle prosthesis system with the comparator covered by the French LPPR, known as the "usual prosthesis".

The main hypothesis being that wearing the SPCM increases the time spent flat-footed in the various walking situations of everyday life, bringing it closer to that of asymptomatic people.

This is a prospective, multicenter, randomized, cross-over study. The participants are transfemoral amputees who have been fitted with a microprocessor-controlled prosthetic knee for more than 3 months.


Eligibility criteria: Inclusion Criteria:

* Amputee at or above knee level
* Person fitted for more than 3 months with a microprocessor-controlled knee support phase and oscillating phase, in accordance with the conditions for reimbursement set out in the LPPR.
* Person with a level of activity according to the International Classification of of Functioning, Disability and Health greater than or equal to d4602 (moving around outside the house and other buildings)
* Person able to understand simple commands, to read and write, and to give their informed consent
* Person who has given informed consent
* Person affiliated to a social security scheme

Exclusion Criteria:

* Minor
* Person of full age subject to a legal protection measure or unable to express consent
* Pregnant or breast-feeding women
* Persons with bilateral amputations
* Person with a neurological or orthopedic pathology with major repercussions on locomotion
* Persons with a ground/knee height of less than 43.5 cm or more than 55 cm
* Persons weighing more than 125 kg
* Foot size less than 24 cm or greater than 30 cm
* Person with a hip disarticulation
* Person without an emergency walking solution
* Person with a suspension fitting with vacuum pump
* Person planning a trip outside Europe or unable to return in less than 24 hours (in case of device failure) for the duration of the protocol.

Primary outcomes:
measure: Comparison of the time (measured as a percentage of the gait cycle) when the foot is flat on the ground during walking in three gait situations: flat, on a slope and going down stairs, with SPCM and the usual prosthesis.
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
Secondary outcomes:
measure: Contralateral ankle power
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
measure: Pelvis elevation
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
measure: Toe clearance
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
measure: Prosthesis evaluation
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
measure: Locomotor abilities
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
measure: Mobility
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
measure: SF-36 Questionnaire
timeFrame: Evaluation after 4 weeks' wear of each of the 2 prostheses
measure: Number of steps
timeFrame: Evaluation after 4 weeks' wear of SPCM
measure: Cadence
timeFrame: Evaluation after 4 weeks' wear of SPCM
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées (HIA) Percy
city: Nancy
country: France
facility: UGECAM-NE - Institut Régional de Médecine Physique et de Readaptation de Nancy
city: Paris
country: France
facility: Insitution Nationale des Invalides
city: Paris
country: France
facility: Institut de Biomécanique Humaine Georges Charpak
Study officials:
References: