Using socket-induced phantom sensations to add walking feedback after lower-limb amputation
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
This trial will test whether changing a prosthetic socket to create phantom limb sensations that line up with walking can help people with a lower-limb amputation walk more naturally.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est Academic / other |
| Locations | 1 site (Nancy) |
| Trial ID | NCT07191795 on ClinicalTrials.gov |
What this trial studies
The project tests whether naturally occurring or socket-induced phantom limb sensations that are synchronized with gait phases can substitute for lost somatosensory feedback and improve walking. Participants will undergo mapping of referred sensations on the residual limb, gait analysis, and brain imaging while different socket modifications are applied to try to evoke coherent phantom sensations. Investigators will compare gait parameters and cognitive load during walking with and without induced sensations and collect semi-structured interviews about the sensations. The study includes people with major lower-limb amputation and asymptomatic control volunteers to isolate effects of phantom sensations on locomotion.
Who should consider this trial
Good fit: Ideal participants are adults with a stable major lower-limb amputation who can walk, have no pain that limits walking, speak French, and can attend study visits at the rehabilitation center in Nancy.
Not a fit: Patients with walking-limiting pain, active psychiatric illness, pregnancy, legal protection status, incompatible medical treatments, or those who do not experience phantom or referred sensations are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could make walking more automatic and symmetric, reduce effort and future joint complications, and improve daily mobility for amputees.
How similar studies have performed: Prior small-scale and proof-of-concept studies and case reports have shown that referred sensations and targeted socket or nerve stimulation can produce useful phantom sensations, but robust clinical evidence of gait improvement is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nancy
- Institut Régional de Médecine Physique et de Réadaptation — Nancy, France (Recruiting)
Study contacts
- Principal investigator: Amelie A Touillet — Institut Régional de Médecine Physique et de Réadaptation
- Study coordinator: Jonathan J Pierret, PhD
- Email: jonathan.pierret@ugecam.assurance-maladie.fr
- Phone: +33383526761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.