Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
NCT Number: NCT06522646
Acronym: SPCM
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amputation|Lower Limb Amputation Above Knee (Injury)
Interventions: DEVICE: SPCM|DEVICE: Usual Prothesis
Sponsor: Institution Nationale des Invalides
Collaborators: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est|Hopital d'instruction des armées Percy (HIA Percy)|Proteor Group|Direction Générale de l'Armement
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-07-09
Completion Date: 2023-05-31
Locations: Hôpital d'Instruction des Armées (HIA) Percy, Clamart, 92140, France|UGECAM-NE - Institut Régional de Médecine Physique et de Readaptation de Nancy, Nancy, 54000, France|Insitution Nationale des Invalides, Paris, 75007, France|Institut de Biomécanique Humaine Georges Charpak, Paris, 75013, France

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.

Primary Outcome Measures: 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., The aim is to compare the adaptation of the prosthetic system to the constraints of everyday life. SPCM adapts the ankle's behavior to the walking situation, and should make it possible to restore the time during which the foot remains flat during the stance phase, in different situations, Evaluation after 4 weeks' wear of each of the 2 prostheses
Secondary Outcome Measures: Contralateral ankle power, Contralateral ankle power is a locomotor compensation device used by transfemoral amputees. It is a biomechanical parameter usually measured by quantified motion analysis (AQM). The SPCM prosthetic system is expected to reduce these power., Evaluation after 4 weeks' wear of each of the 2 prostheses|Pelvis elevation, Pelvis elevation is a locomotor compensation device used by transfemoral amputees. It is a biomechanical parameter usually measured by quantified motion analysis (AQM). The SPCM prosthetic system is expected to reduce these Pelvis elevation., Evaluation after 4 weeks' wear of each of the 2 prostheses|Toe clearance, Toe clearance is the distance between the toe of the foot and the ground during the swing phase. The greater this distance, the safer the patient. With SPCM, the toe clearance should increase, providing greater safety during pitch change in the swing phase., Evaluation after 4 weeks' wear of each of the 2 prostheses|Prosthesis evaluation, The PEQ is composed of 9 validated scales that are each comprised of multiple questions, and there are a number of additional individual questions. Each question is rated between 0 and 100. Higher number will correspond with a more positive response., Evaluation after 4 weeks' wear of each of the 2 prostheses|Locomotor abilities, It is composed of 14 questions about different locomotor activities. A 4-level ordinal scale (0-3 points; ranging from "not able" to "able to accomplish the activity alone") scores the degree of a person's perceived independence in performing each of the 14 activities while wearing the prosthesis. The higher the total score, the greater the patient's abilities., Evaluation after 4 weeks' wear of each of the 2 prostheses|Mobility, The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a self-report instrument for measuring mobility of adults with lower limb amputation. PLUS-M provide a T-score that ranges from 17.5 to 76.6.A higher PLUS-M™ T-score corresponds to greater mobility., Evaluation after 4 weeks' wear of each of the 2 prostheses|SF-36 Questionnaire, Socre of the SF-36 questionnaire, evaluation of the quality of life. The score range from 0 to 100. A higher score mean a better outcome., Evaluation after 4 weeks' wear of each of the 2 prostheses|Number of steps, Quantifying real-life activity. The aim is to check whether the improvements observed during the laboratory motion analysis test are reflected in real life.

Comparison of the number of steps recorded by the prosthesis sensors and those obtained during the laboratory gait analysis. Equivalence between the systems is expected., Evaluation after 4 weeks' wear of SPCM|Cadence, Quantifying real-life activity. The aim is to check whether the improvements observed during the laboratory motion analysis test are reflected in real life.

Comparison of the cadence recorded by the prosthesis sensors and those obtained during the laboratory gait analysis. Equivalence between the systems is expected., Evaluation after 4 weeks' wear of SPCM