Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
NCT ID: NCT07191795
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
228 participants
INTERVENTIONAL
2024-09-16
2030-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation
NCT05880251
Enhancing Abilities in Amputees and Patients With Peripheral Neuropathy Through Restoration of Sensory Feedback
NCT04217005
The Effects of Targeted Phantom Motor Execution on Phantom Limb Control
NCT05247827
Enhancement of Residual Limb Proprioception and Rehabilitation Training Methods With a Vibrotactile Device.
NCT02026570
VR to Evaluate Phantom Limb Pain
NCT05915065
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TT
People with transtibial amputation
Gait analysis
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.
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.
Phantom limb interview
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.
TF
People with transfemoral amputation
Gait analysis
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.
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.
Exploration of the areas of the brain activated during referred sensations
Unilateral transfemoral amputees with detailed referred sensation maps will have their brain activity recorded using a 64-electrode EEG cap. Non-invasive stimuli will be applied to four specific sites: an area on the residual limb that elicits a referred sensation, the corresponding location on the intact foot, a neutral area on the residual limb, and its corresponding location on the intact thigh. This process, involving 400 total stimulations, will be repeated after 6 months to track cortical changes. Non-amputee participants will also be tested as a control group to check for symmetry in brain responses to thigh stimulation. Each session lasts about 2 hours.
Evaluation of the effects of socket modifications on phantom sensations and walking
This phase will evaluate how socket modifications affect phantom sensations and walking in 10 transfemoral amputees. First, the best material to comfortably induce referred sensations will be determined in a small sub-study. Then, each participant will be tested under four conditions: their usual socket and a socket with different rigidity, both with and without a specific local pressure point added inside. The location of this pressure point is based on the user's sensation map. Participants' walking will be analyzed in both lab and real-world environments for each condition, and they will provide feedback on their sensations and which setup they find most helpful. The evaluation involves 4 sessions over 2-3 months
Phantom limb interview
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.
Control
Asymptomatic people
Gait analysis
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.
Exploration of the areas of the brain activated during referred sensations
Unilateral transfemoral amputees with detailed referred sensation maps will have their brain activity recorded using a 64-electrode EEG cap. Non-invasive stimuli will be applied to four specific sites: an area on the residual limb that elicits a referred sensation, the corresponding location on the intact foot, a neutral area on the residual limb, and its corresponding location on the intact thigh. This process, involving 400 total stimulations, will be repeated after 6 months to track cortical changes. Non-amputee participants will also be tested as a control group to check for symmetry in brain responses to thigh stimulation. Each session lasts about 2 hours.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gait analysis
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.
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.
Exploration of the areas of the brain activated during referred sensations
Unilateral transfemoral amputees with detailed referred sensation maps will have their brain activity recorded using a 64-electrode EEG cap. Non-invasive stimuli will be applied to four specific sites: an area on the residual limb that elicits a referred sensation, the corresponding location on the intact foot, a neutral area on the residual limb, and its corresponding location on the intact thigh. This process, involving 400 total stimulations, will be repeated after 6 months to track cortical changes. Non-amputee participants will also be tested as a control group to check for symmetry in brain responses to thigh stimulation. Each session lasts about 2 hours.
Evaluation of the effects of socket modifications on phantom sensations and walking
This phase will evaluate how socket modifications affect phantom sensations and walking in 10 transfemoral amputees. First, the best material to comfortably induce referred sensations will be determined in a small sub-study. Then, each participant will be tested under four conditions: their usual socket and a socket with different rigidity, both with and without a specific local pressure point added inside. The location of this pressure point is based on the user's sensation map. Participants' walking will be analyzed in both lab and real-world environments for each condition, and they will provide feedback on their sensations and which setup they find most helpful. The evaluation involves 4 sessions over 2-3 months
Phantom limb interview
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinique Chantecler
UNKNOWN
Centre Orthopédique Maguelone
UNKNOWN
Centre Helio Marin
UNKNOWN
Institut universitaire de réadaptation Valmante Sud
UNKNOWN
Institut des Sciences du Mouvement
UNKNOWN
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amelie A Touillet
Role: PRINCIPAL_INVESTIGATOR
Institut Régional de Médecine Physique et de Réadaptation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut Régional de Médecine Physique et de Réadaptation
Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANR-23-CE17-0067-02
Identifier Type: OTHER
Identifier Source: secondary_id
2022-A01647-36
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.