AmputationSPCMNCT06522646
Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
A study testing SPCM and Usual Prothesis in people with Amputation and Lower Limb Amputation Above Knee (Injury), run by Institution Nationale des Invalides at 4 sites in France.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Lower Limb Amputation Above Knee (Injury)
- What is being tested?
- SPCM and Usual Prothesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesFrance
- Study dates
- 9 Jul 2018to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital d'Instruction des Armées (HIA) Percy
Clamart, 92140
UGECAM-NE - Institut Régional de Médecine Physique et de Readaptation de Nancy
Nancy, 54000
Insitution Nationale des Invalides
Paris, 75007
Institut de Biomécanique Humaine Georges Charpak
Paris, 75013
About this study
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.
- Being tested
- SPCM, Usual Prothesis
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPCMDevice
During a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis
Usual ProthesisDevice
During a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis
| Study group | Role | What they receive |
|---|---|---|
| SPCM | Experimental | Patients will be fitted with the SPCM prothesis Receives: Device: SPCM |
| Usual Prosthesis | Active comparator | Patients will be fitted with their usual microprocessor prosthesis Receives: Device: Usual Prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Evaluation after 4 weeks' wear of each of the 2 prostheses
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluation after 4 weeks' wear of SPCM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start9 Jul 2018
- Primary completion19 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institution Nationale des Invalides
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522646
- Sponsor's protocol ID
- SPCM
- Acronym
- SPCM
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Microprocessor-controlled Prosthetic Knee-ankle System (SPCM)
- ClinicalTrials.gov ID
- NCT06522646
- Acronym / sponsor ID
- SPCM / SPCM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institution Nationale des InvalidesUniversity, hospital or other
- 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
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPCM | Experimental | Device: SPCMPatients will be fitted with the SPCM prothesis |
| Usual Prosthesis | Active comparator | Device: Usual ProthesisPatients will be fitted with their usual microprocessor prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPCMDuring a period of 4-6 weeks, patients will live in their usual environment with the SPCM prosthesis | Device | SPCM |
| Usual ProthesisDuring a period of 4-6 weeks, patients will live in their usual environment with their usual microprocessor prosthesis | Device | Usual Prosthesis |
Primary outcome
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.
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
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
9 secondary outcomes
Contralateral ankle power
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
Pelvis elevation
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
Toe clearance
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
Prosthesis evaluation
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
Locomotor abilities
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
Mobility
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
SF-36 Questionnaire
Time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses
Number of steps
Time frame: Evaluation after 4 weeks' wear of SPCM
Cadence
Time frame: Evaluation after 4 weeks' wear of SPCM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Amputation
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
Recruiting
Prosthetic Socket Fit Testing System
Amputation
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Recruiting
Clinical Feasibility of the IMES Transradial Prosthesis
Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPCM and Usual Prothesis in people with Amputation and Lower Limb Amputation Above Knee (Injury), run by Institution Nationale des Invalides at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Evaluation after 4 weeks' wear of each of the 2 prostheses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.