Verwendung von Phantomempfindungen, die durch globale und lokale Modifikationen der Prothesenbuchse als somatosensorisches Feedback während des Gehens in Amputierten der unteren Extremitäten induziert werden (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.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Jonathan J Pierret, PhD
- Telefonnummer: +33383526761
- E-Mail: jonathan.pierret@ugecam.assurance-maladie.fr
Studieren Sie die Kontaktsicherung
- Name: Christelle C Requena
- E-Mail: christelle.requena@ugecam.assurance-maladie.fr
Studienorte
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-
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Nancy, Frankreich, 54000
- Rekrutierung
- Institut Régional de Médecine Physique et de Réadaptation
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Kontakt:
- Jonathan Pierret, PhD
- Telefonnummer: +33382526761
- E-Mail: jonathan.pierret@ugecam.assurance-maladie.fr
-
Kontakt:
- Christelle Requena
- E-Mail: christelle.requena@ugecam.assurance-maladie.fr
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Hauptermittler:
- Amelie Touillet
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
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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
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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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Experimental: 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. |
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Experimental: 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. |
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Experimental: 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. |
|
Experimental: 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. |
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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Prevalence of non-painful phantom sensations during walking
Zeitfenster: The first day of the study
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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
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Double support time during level walking at self-selected speed
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Within-participant difference in double support time between usual and modified socket
Zeitfenster: Days 4 to 7 of the study
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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
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Walking pace under laboratory conditions
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Analysis of brain activity related to cognitive load during walking
Zeitfenster: 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
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Gait speed in ecological situation
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Qualitative description of the interaction between phantom sensations and walking
Zeitfenster: 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
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Effect of focal stimulation on phantom sensations
Zeitfenster: Day 3 of the study
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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
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Change in perceived cognitive load (NASA-TLX score) during walking in an ecological setting
Zeitfenster: Day 4 to 7 of the study
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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
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Evaluation of socket comfort
Zeitfenster: 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
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Assessment of mental workload during walking using the NASA-TLX questionnaire
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Qualitative description of the sensations reported for each socket condition
Zeitfenster: Day 4 to 7 of the study
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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
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Change in phantom limb sensation intensity at 6 months for recent amputees
Zeitfenster: 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.
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Walking speed under laboratory conditions
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Step length symmetry index.
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Surface area and intensity of induced phantom sensation maps
Zeitfenster: 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.
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Preferred socket condition
Zeitfenster: Day 7 of the study
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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
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Spatiotemporal gait parameters in ecological situation
Zeitfenster: Days 4 to 7 to the study
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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
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Characterization of phantom limb sensations
Zeitfenster: The first day of the study
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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
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Step length
Zeitfenster: 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
|
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stance and swing phase durations
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Functional Ambulation Performance Score (FAPS)
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Enhanced Gait Variability Index (EGVI)
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Raw NASA-TLX score (RTLX)
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Perceived exertion (Borg CR10)
Zeitfenster: The first day of the study for the control group and the second day of the study for participants with amputation
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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
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Perceived interaction between phantom sensations and walking
Zeitfenster: the second day of the study for participants with amputation
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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
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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Maximum vertical reaction force during walking.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Amelie A Touillet, Institut Régional de Médecine Physique et de Réadaptation
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Motorik
- Bewegung
- Phänomen des Bewegungsapparates muskuloskelettal
- Muskuloskelettaler und neuronales physiologisches Phänomen
- Diagnosetechniken und Verfahren
- Diagnose
- Bevölkerungseigenschaften
- Übung
- Körperliche Untersuchung
- Fortbewegung
- Gesundheit
- Körperliche Fitness
- Gang
- Physikalische funktionale Leistung
- Gehen
- Ganganalyse
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 2022-A01647-36
- ANR-23-CE17-0067-02 (Andere Kennung: ANR)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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