Lower Limb AmputationNCT05224232
Protocole Access-Socket
A study testing Access Socket and Rigid socket in people with Lower Limb Amputation, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 4 sites in France.
Trial summary
Lower limb amputation has a definitive impact on a person's locomotor abilities, considerably reducing his or her autonomy in everyday life. 50% of lower limb amputees in France are trans-femoral. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Access Socket and Rigid socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Feb 2022to 31 Oct 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
- Unilateral or bilateral trans-femoral amputees;
- Fitted with a rigid carbon insert;
- Any type of stump;
- Any etiology;
- Person able to understand simple commands, to read, write and give informed consent or having the possibility to be accompanied by a trusted person in case of inability to write or read independently;
- Person who has given informed consent;
- Person who has reached the age of 18 years;
- Person affiliated to the french social security system
Who cannot join
- Fitted with a collar fixed on a socket
- Using SHA for inserting the insert;
- Pregnant or nursing woman;
- Minor;
- Person of full age under legal protection or unable to give consent;
- Person under guardianship or curatorship;
- Person under legal protection.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital d'Instruction des Armées (HIA) Percy
Clamart, 92140
Institut Régional de Médecine Physique et de Réadaptation de Nancy
Nancy, 54000
Centre d'Etudes et de Recherche sur l'Appareillage des Handicapés
Paris, 75700
Institution Nationale des Invalides
Paris, 75700
About this study
Official title: Access Socket Protocol: Evaluation of Comfort and Quality of Life Associated With the Use of a Soft Socket for Femoral Prosthesis
Lower limb amputation has a definitive impact on a person's locomotor abilities, considerably reducing his or her autonomy in everyday life. 50% of lower limb amputees in France are trans-femoral. The femoral prosthesis must be adapted to allow the amputee to walk in everyday situations and to make the range of activities practiced by non-amputees accessible to them. Sitting posture, which represents an important part of a day, must also be comfortable.
Comfort will be closely linked to the socket, which ensures the transmission of the mechanical actions of the prosthesis to the body of the amputee through the residual limb. This must be done without damaging the integrity of the biological tissues at the interface. The challenge is therefore to transmit the mechanical actions inherent to the use of the prosthesis while being as comfortable as possible. The most common form of femoral socket is the one with included ishions, which by its structure limits the rotation of the socket around the residual limb. However, it limits hip joint amplitudes, which significantly impacts comfort during walking, especially when the individual must evolve in constraining environments (irregular terrain, slopes, uphill, downhill). Comfort is also limited when putting the prosthesis in place and when sitting, because of the limits of the socket that go up into the groin and the buttock. Discomfort can also be induced by contact and clamping surfaces.
Read more
Only 42% of amputees are satisfied with their sockets. An uncomfortable or wound-inducing brace will not be worn or will be worn only a little, which can increase the risk of comorbidities. One solution to the comfort issue could be the Access Socket (AS) soft socket, which is exactly the same shape and manufacturing principles as the Rigid Included Carbon Socket (ER), but combines a rigid structure with soft areas. These soft areas allow pressure to be distributed within the socket, allowing for some deformation, while maintaining the mechanical properties necessary for walking.
The objective of this study is to compare the comfort perceived by amputees when wearing an AS soft socket versus their RE, both sockets being mounted identically on the patients' usual medical devices.
The hypothesize is that scores on the various comfort, satisfaction, and mobility scales should be better when patients wear the soft socket compared to the rigid socket.
In this multicenter, randomized, cross-over study, patients will wear the rigid socket and then the access-socket (or vice versa), over a 4-week period for each socket. The two sockets will have an identical shape and will be mounted in the same way on the patients' medical device. At the end of each 4-week period, patients will fill out self-questionnaires (PEQ, SCS, PLUS-M, ESAT and SF-36) to evaluate their comfort, satisfaction and ambulation.
- Conditions
- Lower Limb Amputation
- Being tested
- Access Socket, Rigid socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access SocketDevice
During a period of 4 weeks, patients will live in their usual environment with the soft socket (Access-Socket)
Rigid socketDevice
During a period of 4 weeks, patients will live in their usual environment with their usual rigid socket
| Study group | Role | What they receive |
|---|---|---|
| Access Socket | Experimental | Patients will be fitted with the access socket Receives: Device: Access Socket |
| Rigid socket | Active comparator | Patients will be fitted with their usual rigid socket Receives: Device: Rigid socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Score of the Utility subscale of the Prosthesis Evaluation Questionnaire. The score ranges from 0 to 10. A higher score mean a better outcome.
Measured: Comfort will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Secondary outcomes (4)
Satisfaction with the socket
Score of the french version of the Quebec USer Evaluation of Satisfaction With Assistive Technology. The score ranges from 0 to 5. A higher score mean a better outcome.
Measured: Satisfaction will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Quality of lie
Score of the Short-Form 36 questionnaire. The score ranges from 0 to 100. A higher score mean a better outcome.
Measured: Qualitify of life will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Mobility
Score of the Mobility subscale of the PLUS-Mobility questionnaire. This scale needs to convert a raw score (from 12 to 60) in a T-score (from 21.8 to 71.4). A higher score means a better outcome
Measured: Mobility will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Comfort during specific situation
Score of the "Socket Comfort Score" scale. This scale is a visual analogic scale and ranges from 0 to 10. A higher score means a better outcome.
Measured: Comfort during specific situation will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start14 Feb 2022
- Primary completion31 Dec 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Collaborators
- Institution Nationale des Invalides, Hôpital d'Instruction des armées Percy
- Responsible party
- Sponsor
- Investigators
- Isabelle Loiret, PhD, Principal investigator, Institut Régional de Médecine Physique et de Réadaptation de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224232
- Sponsor's protocol ID
- IRR-CLP-2020-9
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access Socket Protocol: Evaluation of Comfort and Quality of Life Associated With the Use of a Soft Socket for Femoral Prosthesis
- ClinicalTrials.gov ID
- NCT05224232
- Acronym / sponsor ID
- IRR-CLP-2020-9
- Conditions
- Lower Limb Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Collaborators
- Institution Nationale des Invalides, Hôpital d'Instruction des armées Percy
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 4 Feb 2022 (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.
Lower limb amputation has a definitive impact on a person's locomotor abilities, considerably reducing his or her autonomy in everyday life. 50% of lower limb amputees in France are trans-femoral. The femoral prosthesis must be adapted to allow the amputee to walk in everyday situations and to make the range of activities practiced by non-amputees accessible to them. Sitting posture, which represents an important part of a day, must also be comfortable.
Comfort will be closely linked to the socket, which ensures the transmission of the mechanical actions of the prosthesis to the body of the amputee through the residual limb. This must be done without damaging the integrity of the biological tissues at the interface. The challenge is therefore to transmit the mechanical actions inherent to the use of the prosthesis while being as comfortable as possible. The most common form of femoral socket is the one with included ishions, which by its structure limits the rotation of the socket around the residual limb. However, it limits hip joint amplitudes, which significantly impacts comfort during walking, especially when the individual must evolve in constraining environments (irregular terrain, slopes, uphill, downhill). Comfort is also limited when putting the prosthesis in place and when sitting, because of the limits of the socket that go up into the groin and the buttock. Discomfort can also be induced by contact and clamping surfaces.
Only 42% of amputees are satisfied with their sockets. An uncomfortable or wound-inducing brace will not be worn or will be worn only a little, which can increase the risk of comorbidities. One solution to the comfort issue could be the Access Socket (AS) soft socket, which is exactly the same shape and manufacturing principles as the Rigid Included Carbon Socket (ER), but combines a rigid structure with soft areas. These soft areas allow pressure to be distributed within the socket, allowing for some deformation, while maintaining the mechanical properties necessary for walking.
The objective of this study is to compare the comfort perceived by amputees when wearing an AS soft socket versus their RE, both sockets being mounted identically on the patients' usual medical devices.
The hypothesize is that scores on the various comfort, satisfaction, and mobility scales should be better when patients wear the soft socket compared to the rigid socket.
In this multicenter, randomized, cross-over study, patients will wear the rigid socket and then the access-socket (or vice versa), over a 4-week period for each socket. The two sockets will have an identical shape and will be mounted in the same way on the patients' medical device. At the end of each 4-week period, patients will fill out self-questionnaires (PEQ, SCS, PLUS-M, ESAT and SF-36) to evaluate their comfort, satisfaction and ambulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access Socket | Experimental | Device: Access SocketPatients will be fitted with the access socket |
| Rigid socket | Active comparator | Device: Rigid socketPatients will be fitted with their usual rigid socket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Unilateral or bilateral trans-femoral amputees;
- Fitted with a rigid carbon insert;
- Any type of stump;
- Any etiology;
- Person able to understand simple commands, to read, write and give informed consent or having the possibility to be accompanied by a trusted person in case of inability to write or read independently;
Key exclusion criteria (7 listed)
- Fitted with a collar fixed on a socket
- Using SHA for inserting the insert;
- Pregnant or nursing woman;
- Minor;
- Person of full age under legal protection or unable to give consent;
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 |
|---|---|---|
| Access SocketDuring a period of 4 weeks, patients will live in their usual environment with the soft socket (Access-Socket) | Device | Access Socket |
| Rigid socketDuring a period of 4 weeks, patients will live in their usual environment with their usual rigid socket | Device | Rigid socket |
Primary outcome
Comfort
Time frame: Comfort will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Score of the Utility subscale of the Prosthesis Evaluation Questionnaire. The score ranges from 0 to 10. A higher score mean a better outcome.
4 secondary outcomes
Satisfaction with the socket
Time frame: Satisfaction will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Quality of lie
Time frame: Qualitify of life will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Mobility
Time frame: Mobility will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
Comfort during specific situation
Time frame: Comfort during specific situation will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket
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 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Lower Limb Amputation
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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.
Isabelle Loiret, PhD principal investigator
Institut Régional de Médecine Physique et de Réadaptation de Nancy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access Socket and Rigid socket in people with Lower Limb Amputation, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est 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 8 inclusion and 7 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 7 Feb 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?
Comfort (time frame: Comfort will be evaluated after 4 weeks of wearing the rigid socket and after 4 weeks of wearing the Access-Socket). 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 7 Feb 2024.