Lower Limb AmputationPhantomWalkNCT07191795
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
A study testing Gait analysis, Mapping of referred sensations. and Evaluation of the effects of socket modifications on phantom sensations and walking in people with Lower Limb Amputation, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
Trial summary
Following lower-limb amputation, the loss of somatosensory information from the missing limb renders walking less automatic, more cognitively demanding, and often asymmetric, which can lead to secondary pathologies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Gait analysis, Mapping of referred sensations. and Evaluation of the effects of socket modifications on phantom sensations and walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2024to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with amputations:
- Major lower limb amputation
- Understand and be able to express oneself in the French language (for semi-structured interviews)
- Affiliated with a social security scheme
- Asymptomatic volunteer participants:
- No major surgery on the lower limbs for at least 3 years
Show all 9Show fewer
- No minor injury to the trunk, lower or upper limbs that could influence walking for at least 1 year
- Understand and be able to express oneself in the French language
- Affiliated with a social security scheme
Who cannot join
- History of psychiatric disorders
- Pregnant or breastfeeding woman
- Minor
- Adult subject to a legal protection measure
- Person under guardianship or conservatorship
- Person under a judicial protection order
- Pain affecting walking (trunk, residual limb, phantom limb, contralateral limb)
- Medical treatment incompatible with walking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christelle C Requena contact
France1 site, 1 recruiting
- Recruiting
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
Jonathan Pierret, PhD, +33382526761, jonathan.pierret@ugecam.assurance-maladie.fr
Christelle Requena, christelle.requena@ugecam.assurance-maladie.fr
About this study
Following lower-limb amputation, the loss of somatosensory information from the missing limb renders walking less automatic, more cognitively demanding, and often asymmetric, which can lead to secondary pathologies.
Hypothesis: This study is based on the hypothesis that phantom limb sensations (PLS), when coherent with the prosthetic device's movements and the phases of the gait cycle, can compensate for the loss of somatosensory feedback and thereby improve locomotion for individuals with amputation. It is further hypothesized that it is possible to artificially induce these coherent and useful sensations, notably through "referred sensations" elicited by stimulation of the residual limb (e.g., via the prosthetic socket).
Read more
Objectives: The project aims to:
- Determine whether the natural presence of phantom limb sensations during walking impacts gait parameters.
- Confirm in a larger patient population that modifications to the prosthetic socket can induce or enhance phantom sensations that are perceived as useful for walking.
- Investigate whether these perceptual changes (induced or enhanced) are associated with objective, measurable improvements in gait quality.
- Conditions
- Lower Limb Amputation
- Being tested
- Gait analysis, Mapping of referred sensations., Evaluation of the effects of socket modifications on phantom sensations and walking, Phantom limb interview
- Keywords
- Phantom Limb Sensation, Referred Sensation, Somatosensory Feedback, Lower Limb Prosthesis, Prosthetic Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysisOther
Participants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests.
Mapping of referred sensations.Other
Participants reporting referred sensations in gait analysis phase will undergo further testing. The study will investigate whether prosthesis pressure or a specific socket interaction causes these sensations. A 3x3 cm grid will be drawn on the residual limb to systematically map referred sensations using various stimuli (brush, pressure tip, electrical stimulation). Participants will rate the intensity and describe the location of any resulting phantom sensations. This mapping will be repeated after 6 months to assess the stability of these sensations over time, with the ultimate goal of potentially using them to provide sensory feedback for prosthesis users. The session will last approximately 2 hours.
Evaluation of the effects of socket modifications on phantom sensations and walkingOther
In 10 unilateral transfemoral amputees with stable induced phantom sensations, this phase evaluates how a personalized socket modification affects phantom sensations and walking. With the prosthetist, a localized thickness (e.g., silicone insert) is added inside the usual socket at the stable stimulation sites identified on the residual-limb map, after measuring socket pressure with a thin sensor array. Each participant is tested in two conditions in a fixed order: usual socket first, then modified socket. The order is not randomized because induced sensations may persist after the modification is removed. For each condition, gait is analyzed in the laboratory and on the ecological course (4 sessions; conditions no more than 4 weeks apart). Participants describe their sensations, rate cognitive load, effort and socket comfort, and indicate which condition is most helpful for walking.
Phantom limb interviewOther
A semi-structured interview will be conducted to ask participants to describe their phantom limb sensations (type, location, intensity) under three conditions: without their prosthesis, while standing with it, and while walking with it. This aims to identify factors influencing these sensations. Additionally, a brief physical examination of the residual limb will be performed to see if touch in specific areas triggers any referred sensations.
| Study group | Role | What they receive |
|---|---|---|
| Amputees w-o SF | Experimental | People without fantom sensation during gait Receives: Other: Gait analysis; Other: Mapping of referred sensations.; Other: Phantom limb interview |
| Amputees H-SF | Experimental | People with phantom sensations who are caregivers Receives: Other: Gait analysis; Other: Mapping of referred sensations.; Other: Evaluation of the effects of socket modifications on phantom sensations and walking; Other: Phantom limb interview |
| Control | Experimental | Asymptomatic people Receives: Other: Gait analysis |
| Amputees B-SF | Experimental | People with bothersome phantom sensations Receives: Other: Gait analysis; Other: Mapping of referred sensations.; Other: Evaluation of the effects of socket modifications on phantom sensations and walking; Other: Phantom limb interview |
| Amputees N-SF | Experimental | People with neutral phantom sensations Receives: Other: Gait analysis; Other: Mapping of referred sensations.; Other: Evaluation of the effects of socket modifications on phantom sensations and walking; Other: Phantom limb interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of non-painful phantom sensations during walking
Proportion of amputee participants able to walk who report non-painful phantom sensations during walking, collected during a standardized semi-structured interview. Reported as a proportion with its exact (Clopper-Pearson) 95% confidence interval
Measured: The first day of the study
Double support time during level walking at self-selected speed
Double support time, defined as the sum of the initial and terminal double support periods of the prosthetic-limb gait cycle, expressed as a percentage of gait cycle duration (%). Measured by 3D motion analysis and force plates during level overground walking at self-selected speed in the laboratory (spontaneous condition).
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Within-participant difference in double support time between usual and modified socket
Difference in double support time (% of gait cycle, same definition and walking condition as Phase 2) between walking with the usual socket and walking with the socket modified by a focal thickness addition designed to induce phantom sensations, in transfemoral amputees. Conditions assessed in a fixed order (usual socket first). Reported as mean difference with 95% confidence interval.
Measured: Days 4 to 7 of the study
Secondary outcomes (23)
Walking pace under laboratory conditions
The number of steps per minute (steps/min) when walking at a comfortable speed. Measured using inertial measurement units or the Vicon system.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Analysis of brain activity related to cognitive load during walking
Electroencephalographic (EEG) activity will be recorded via a headset. Cognitive load will be quantified by analyzing the power ratio in specific frequency bands at the frontal electrodes.
Measured: The second day of the study for participants with amputation
Gait speed in ecological situation
The average walking speed (in m/s) measured using inertial measurement units and pressure soles (Loadsol) during a predefined outdoor route including various difficulties (stairs, slopes, etc.).
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Qualitative description of the interaction between phantom sensations and walking
Participants' verbal descriptions of the nature of the interaction (facilitating, hindering, neutral), the evolution and characteristics of phantom sensations during walking will be collected via a structured interview at the end of the session. The data will be analyzed thematically.
Measured: The second day of the study for participants with amputation
Effect of focal stimulation on phantom sensations
For the subgroup of participants reporting interaction between sensations and focal stimulation after various stimulations using a rubber tip (pressure), a brush, and a needle. The change in sensation intensity (rated on a scale of 0 to 5). The result will be categorized as "increase," "decrease," or "no change."
Measured: Day 3 of the study
Change in perceived cognitive load (NASA-TLX score) during walking in an ecological setting
Perceived mental workload will be assessed using the NASA-TLX questionnaire immediately after each walking session. The total score will be compared between the four socket conditions.
Measured: Day 4 to 7 of the study
Evaluation of socket comfort
The overall comfort perceived for each condition will be assessed at the end of each session using a Numerical Rating Scale (NRS) ranging from 0 (very uncomfortable) to 10 (very comfortable). The average score will be compared between the four conditions.
Measured: Day 4 to 7 of the study
Assessment of mental workload during walking using the NASA-TLX questionnaire
The cognitive load perceived by the participant will be assessed using the NASA Task Load Index (NASA-TLX) self-report questionnaire. The total score, ranging from 0 to 100, will be calculated. A higher score indicates a greater perceived cognitive load.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Qualitative description of the sensations reported for each socket condition
For each condition, a structured description of the sensations reported (type, location, intensity, perceived usefulness for walking) will be collected through an interview. The data will be analyzed thematically to compare the sensory experience.
Measured: Day 4 to 7 of the study
Change in phantom limb sensation intensity at 6 months for recent amputees
For the subgroup of participants with an amputation of less than 6 months at inclusion, the intensity of phantom sensations will be re-assessed using the 3-point ordinal scale.
Measured: The first day of the study and during the 6-month follow-up visit.
Walking speed under laboratory conditions
The participant's average walking speed, measured in meters per second (m/s). The measurement will be collected using inertial measurement units (IMUs) and/or a Vicon motion capture system while the participant walks on hard ground or on a treadmill at their self-selected speed.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Step length symmetry index.
Gait symmetry will be calculated based on the stride length of the affected (or corresponding) limb and the healthy limb. The symmetry index is a unitless ratio (or percentage) that quantifies the difference between the two limbs. A value of 1 (or 100%) indicates perfect symmetry. Measured using inertial measurement units or the Vicon system.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Surface area and intensity of induced phantom sensation maps
For each type of stimulation, the number of 3×3 cm areas of the residual limb eliciting phantom sensations is counted and the total surface area (cm²) is calculated (number × 9). For each reactive area, the participant rates the intensity of the induced sensation on a three-level ordinal scale (weak, medium, strong).
Measured: 2nd or 3rd day of the study depending on whether the participant with an amputation was included in phase 2 or not and during the 6-month follow-up visit.
Preferred socket condition
At the end of Phase 4, participants indicate which condition (usual socket or modified socket) they perceive as most facilitating for walking.
Measured: Day 7 of the study
Spatiotemporal gait parameters in ecological situation
Walking speed (m/s), cadence (steps/min) and step symmetry index measured with inertial sensors and pressure insoles during the predefined indoor/outdoor course, compared between the usual socket and the modified socket.
Measured: Days 4 to 7 to the study
Characterization of phantom limb sensations
Composite assessment of phantom limb sensations via a semi-structured interview: type of sensation, location, intensity (weak, medium, strong) and perceived influence on walking (helpful, neutral, disturbing).
Measured: The first day of the study
Step length
Step length (m) of the prosthetic and intact limbs during level walking at self-selected speed.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
stance and swing phase durations
Stance and swing phase durations of each limb, expressed as % of gait cycle.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Functional Ambulation Performance Score (FAPS)
Composite score computed from spatiotemporal parameters, ranging from 30 (highly pathological gait) to 100 (healthy gait).
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Enhanced Gait Variability Index (EGVI)
Composite gait variability score computed from step-to-step spatiotemporal parameters; values between 95 and 105 indicate healthy variability.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Raw NASA-TLX score (RTLX)
Perceived cognitive workload during walking, computed as the mean of the six NASA-TLX dimensions, each rated 0-10 (higher = higher workload).
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Perceived exertion (Borg CR10)
Borg CR10 score (0-10; higher = greater exertion), collected after each walking condition.
Measured: The first day of the study for the control group and the second day of the study for participants with amputation
Perceived interaction between phantom sensations and walking
Visual analog scale from -5 (very disturbing) to +5 (very helpful), completed by participants with phantom sensations after each walking condition; analyzed as a continuous variable
Measured: the second day of the study for participants with amputation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start16 Sep 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Collaborators
- Clinique Chantecler, Centre Helio Marin, Institut universitaire de réadaptation Valmante Sud, Centre de rééducation Maguelone, Fondation Saint-Hélier
- Responsible party
- Sponsor
- Investigators
- Amelie A Touillet, Principal investigator, Institut Régional de Médecine Physique et de Réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191795
- Sponsor's protocol ID
- 2022-A01647-36
- Other IDs
- ANR-23-CE17-0067-02
- Acronym
- PhantomWalk
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
- ClinicalTrials.gov ID
- NCT07191795
- Acronym / sponsor ID
- PhantomWalk / 2022-A01647-36
- Conditions
- Lower Limb Amputation
- Keywords
- Phantom Limb Sensation, Referred Sensation, Somatosensory Feedback, Lower Limb Prosthesis, Prosthetic Gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Collaborators
- Clinique Chantecler, Centre Helio Marin, Institut universitaire de réadaptation Valmante Sud, Centre de rééducation Maguelone, Fondation Saint-Hélier
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 25 Sep 2025 (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.
Following lower-limb amputation, the loss of somatosensory information from the missing limb renders walking less automatic, more cognitively demanding, and often asymmetric, which can lead to secondary pathologies.
Hypothesis: This study is based on the hypothesis that phantom limb sensations (PLS), when coherent with the prosthetic device's movements and the phases of the gait cycle, can compensate for the loss of somatosensory feedback and thereby improve locomotion for individuals with amputation. It is further hypothesized that it is possible to artificially induce these coherent and useful sensations, notably through "referred sensations" elicited by stimulation of the residual limb (e.g., via the prosthetic socket).
Objectives: The project aims to:
- Determine whether the natural presence of phantom limb sensations during walking impacts gait parameters.
- Confirm in a larger patient population that modifications to the prosthetic socket can induce or enhance phantom sensations that are perceived as useful for walking.
- Investigate whether these perceptual changes (induced or enhanced) are associated with objective, measurable improvements in gait quality.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Amputees w-o SF | Experimental | Other: Gait analysis, Other: Mapping of referred sensations., Other: Phantom limb interviewPeople without fantom sensation during gait |
| Amputees H-SF | Experimental | Other: Gait analysis, Other: Mapping of referred sensations., Other: Evaluation of the effects of socket modifications on phantom sensations and walking, Other: Phantom limb interviewPeople with phantom sensations who are caregivers |
| Control | Experimental | Other: Gait analysisAsymptomatic people |
| Amputees B-SF | Experimental | Other: Gait analysis, Other: Mapping of referred sensations., Other: Evaluation of the effects of socket modifications on phantom sensations and walking, Other: Phantom limb interviewPeople with bothersome phantom sensations |
| Amputees N-SF | Experimental | Other: Gait analysis, Other: Mapping of referred sensations., Other: Evaluation of the effects of socket modifications on phantom sensations and walking, Other: Phantom limb interviewPeople with neutral phantom sensations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants with amputations:
- Asymptomatic volunteer participants:
Key exclusion criteria (8 listed)
- History of psychiatric disorders
- Pregnant or breastfeeding woman
- Minor
- Adult subject to a legal protection measure
- Person under guardianship or conservatorship
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 |
|---|---|---|
| Gait analysisParticipants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests. | Other | Amputees B-SF, Amputees H-SF, Amputees N-SF, Amputees w-o SF, Control |
| Mapping of referred sensations.Participants reporting referred sensations in gait analysis phase will undergo further testing. The study will investigate whether prosthesis pressure or a specific socket interaction causes these sensations. A 3x3 cm grid will be drawn on the residual limb to systematically map referred sensations using various stimuli (brush, pressure tip, electrical stimulation). Participants will rate the intensity and describe the location of any resulting phantom sensations. This mapping will be repeated after 6 months to assess the stability of these sensations over time, with the ultimate goal of potentially using them to provide sensory feedback for prosthesis users. The session will last approximately 2 hours. | Other | Amputees B-SF, Amputees H-SF, Amputees N-SF, Amputees w-o SF |
| Evaluation of the effects of socket modifications on phantom sensations and walkingIn 10 unilateral transfemoral amputees with stable induced phantom sensations, this phase evaluates how a personalized socket modification affects phantom sensations and walking. With the prosthetist, a localized thickness (e.g., silicone insert) is added inside the usual socket at the stable stimulation sites identified on the residual-limb map, after measuring socket pressure with a thin sensor array. Each participant is tested in two conditions in a fixed order: usual socket first, then modified socket. The order is not randomized because induced sensations may persist after the modification is removed. For each condition, gait is analyzed in the laboratory and on the ecological course (4 sessions; conditions no more than 4 weeks apart). Participants describe their sensations, rate cognitive load, effort and socket comfort, and indicate which condition is most helpful for walking. | Other | Amputees B-SF, Amputees H-SF, Amputees N-SF |
| Phantom limb interviewA semi-structured interview will be conducted to ask participants to describe their phantom limb sensations (type, location, intensity) under three conditions: without their prosthesis, while standing with it, and while walking with it. This aims to identify factors influencing these sensations. Additionally, a brief physical examination of the residual limb will be performed to see if touch in specific areas triggers any referred sensations. | Other | Amputees B-SF, Amputees H-SF, Amputees N-SF, Amputees w-o SF |
Primary outcome
Prevalence of non-painful phantom sensations during walking
Time frame: The first day of the study
Proportion of amputee participants able to walk who report non-painful phantom sensations during walking, collected during a standardized semi-structured interview. Reported as a proportion with its exact (Clopper-Pearson) 95% confidence interval
Double support time during level walking at self-selected speed
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Double support time, defined as the sum of the initial and terminal double support periods of the prosthetic-limb gait cycle, expressed as a percentage of gait cycle duration (%). Measured by 3D motion analysis and force plates during level overground walking at self-selected speed in the laboratory (spontaneous condition).
Within-participant difference in double support time between usual and modified socket
Time frame: Days 4 to 7 of the study
Difference in double support time (% of gait cycle, same definition and walking condition as Phase 2) between walking with the usual socket and walking with the socket modified by a focal thickness addition designed to induce phantom sensations, in transfemoral amputees. Conditions assessed in a fixed order (usual socket first). Reported as mean difference with 95% confidence interval.
23 secondary outcomes
Walking pace under laboratory conditions
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Analysis of brain activity related to cognitive load during walking
Time frame: The second day of the study for participants with amputation
Gait speed in ecological situation
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Qualitative description of the interaction between phantom sensations and walking
Time frame: The second day of the study for participants with amputation
Effect of focal stimulation on phantom sensations
Time frame: Day 3 of the study
Change in perceived cognitive load (NASA-TLX score) during walking in an ecological setting
Time frame: Day 4 to 7 of the study
Evaluation of socket comfort
Time frame: Day 4 to 7 of the study
Assessment of mental workload during walking using the NASA-TLX questionnaire
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Qualitative description of the sensations reported for each socket condition
Time frame: Day 4 to 7 of the study
Change in phantom limb sensation intensity at 6 months for recent amputees
Time frame: The first day of the study and during the 6-month follow-up visit.
Walking speed under laboratory conditions
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Step length symmetry index.
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Surface area and intensity of induced phantom sensation maps
Time frame: 2nd or 3rd day of the study depending on whether the participant with an amputation was included in phase 2 or not and during the 6-month follow-up visit.
Preferred socket condition
Time frame: Day 7 of the study
Spatiotemporal gait parameters in ecological situation
Time frame: Days 4 to 7 to the study
Characterization of phantom limb sensations
Time frame: The first day of the study
Step length
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
stance and swing phase durations
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Functional Ambulation Performance Score (FAPS)
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Enhanced Gait Variability Index (EGVI)
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Raw NASA-TLX score (RTLX)
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Perceived exertion (Borg CR10)
Time frame: The first day of the study for the control group and the second day of the study for participants with amputation
Perceived interaction between phantom sensations and walking
Time frame: the second day of the study for participants with amputation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
Christelle C Requena contact
Amelie A Touillet principal investigator
Institut Régional de Médecine Physique et de Réadaptation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis, Mapping of referred sensations. and Evaluation of the effects of socket modifications on phantom sensations and walking in people with Lower Limb Amputation, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan J Pierret, PhD (+33383526761, jonathan.pierret@ugecam.assurance-maladie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of non-painful phantom sensations during walking (time frame: The first day of the study). The study lists 3 primary outcomes in all. 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 3 Nov 2026.