- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07191795
- Oryginalna próba
Zastosowanie wrażeń fantomowych wywołanych przez globalne i lokalne modyfikacje gniazda protetycznego jako somatosensoryczne informacje zwrotne podczas chodzenia po amputacjach kończyn dolnych (PhantomWalk)
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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jonathan J Pierret, PhD
- Numer telefonu: +33383526761
- E-mail: jonathan.pierret@ugecam.assurance-maladie.fr
Kopia zapasowa kontaktu do badania
- Nazwa: Christelle C Requena
- E-mail: christelle.requena@ugecam.assurance-maladie.fr
Lokalizacje studiów
-
-
-
Nancy, Francja, 54000
- Rekrutacyjny
- Institut Régional de Médecine Physique et de Réadaptation
-
Kontakt:
- Jonathan Pierret, PhD
- Numer telefonu: +33382526761
- E-mail: jonathan.pierret@ugecam.assurance-maladie.fr
-
Kontakt:
- Christelle Requena
- E-mail: christelle.requena@ugecam.assurance-maladie.fr
-
Główny śledczy:
- Amelie Touillet
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
-
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
- 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
Exclusion Criteria:
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Nielosowe
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Amputees w-o SF
People without fantom sensation during gait |
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. 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. 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. |
|
Eksperymentalny: Amputees H-SF
People with phantom sensations who are caregivers |
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. 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. 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. 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. |
|
Eksperymentalny: Control
Asymptomatic people |
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. |
|
Eksperymentalny: Amputees B-SF
People with bothersome phantom sensations |
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. 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. 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. 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. |
|
Eksperymentalny: Amputees N-SF
People with neutral phantom sensations |
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. 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. 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. 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Prevalence of non-painful phantom sensations during walking
Ramy czasowe: 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 |
The first day of the study
|
|
Double support time during level walking at self-selected speed
Ramy czasowe: 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). |
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
Ramy czasowe: 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. |
Days 4 to 7 of the study
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Walking pace under laboratory conditions
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
The number of steps per minute (steps/min) when walking at a comfortable speed. Measured using inertial measurement units or the Vicon system. |
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
Ramy czasowe: The second day of the study for participants with amputation
|
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. |
The second day of the study for participants with amputation
|
|
Gait speed in ecological situation
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
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.). |
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
Ramy czasowe: The second day of the study for participants with amputation
|
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. |
The second day of the study for participants with amputation
|
|
Effect of focal stimulation on phantom sensations
Ramy czasowe: Day 3 of the study
|
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." |
Day 3 of the study
|
|
Change in perceived cognitive load (NASA-TLX score) during walking in an ecological setting
Ramy czasowe: Day 4 to 7 of the study
|
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. |
Day 4 to 7 of the study
|
|
Evaluation of socket comfort
Ramy czasowe: Day 4 to 7 of the study
|
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. |
Day 4 to 7 of the study
|
|
Assessment of mental workload during walking using the NASA-TLX questionnaire
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
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. |
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
Ramy czasowe: Day 4 to 7 of the study
|
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. |
Day 4 to 7 of the study
|
|
Change in phantom limb sensation intensity at 6 months for recent amputees
Ramy czasowe: The first day of the study and during the 6-month follow-up visit.
|
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. |
The first day of the study and during the 6-month follow-up visit.
|
|
Walking speed under laboratory conditions
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
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. |
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.
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
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. |
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
Ramy czasowe: 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.
|
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). |
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
Ramy czasowe: Day 7 of the study
|
At the end of Phase 4, participants indicate which condition (usual socket or modified socket) they perceive as most facilitating for walking. |
Day 7 of the study
|
|
Spatiotemporal gait parameters in ecological situation
Ramy czasowe: Days 4 to 7 to the study
|
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. |
Days 4 to 7 to the study
|
|
Characterization of phantom limb sensations
Ramy czasowe: The first day of the study
|
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). |
The first day of the study
|
|
Step length
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
Step length (m) of the prosthetic and intact limbs during level walking at self-selected speed. |
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
Ramy czasowe: 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 of each limb, expressed as % of gait cycle. |
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)
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
Composite score computed from spatiotemporal parameters, ranging from 30 (highly pathological gait) to 100 (healthy gait). |
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)
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
Composite gait variability score computed from step-to-step spatiotemporal parameters; values between 95 and 105 indicate healthy variability. |
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)
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
Perceived cognitive workload during walking, computed as the mean of the six NASA-TLX dimensions, each rated 0-10 (higher = higher workload). |
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)
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
Borg CR10 score (0-10; higher = greater exertion), collected after each walking condition. |
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
Ramy czasowe: the second day of the study for participants with amputation
|
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 |
the second day of the study for participants with amputation
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maximum vertical reaction force during walking.
Ramy czasowe: The first day of the study for the control group and the second day of the study for participants with amputation
|
The maximum force exerted on the ground with each step, measured in Newtons (N) or as a percentage of body weight (%BW). The measurement will be taken using force platforms (AMTI), pressure insoles (Loadsol), or an instrumented mat (Zeno). |
The first day of the study for the control group and the second day of the study for participants with amputation
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Amelie A Touillet, Institut Régional de Médecine Physique et de Réadaptation
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Techniki i procedury diagnostyczne
- Diagnoza
- Charakterystyka populacji
- Ćwiczenia
- Badanie fizyczne
- Lokomocja
- Zdrowie
- Sprawność fizyczna
- Chód
- Fizyczna wydajność funkcjonalna
- Pieszy
- Analiza chodu
Inne numery identyfikacyjne badania
- 2022-A01647-36
- ANR-23-CE17-0067-02 (Inny identyfikator: ANR)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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