NCT06424249 Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
| NCT ID | NCT06424249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Amputees / Rehabilitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-10-14 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance. Improved gait patterns and use of the prosthesis contribute to an overall improvement in the amputee's autonomy. Virtual reality coupled with movement analysis allows personalization of treatment with objective assessment of progress. The study authors hypothesize that a virtual reality protocol for the dynamic balance of a unilateral transtibial amputee in initial rehabilitation will improve the dynamic balance assessment criteria compared with a conventional rehabilitation protocol.
Eligibility Criteria
Inclusion Criteria: * Unilateral transtibial amputees in hospitalized in the rehabilitation of the musculoskeletal system service * All etiologies: vascular, traumatic and septic. * Adapted vascular equipment validated by physician. * Able to walk for 5 minutes on a treadmill without technical assistance. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * The subject is participating in an interventional study or one involving a drug or medical device, or is in a period of exclusion determined by a previous study * Patient already included in the present study. * The subject refuses to or is unable to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Patients with uncorrected or untreated visual disorders. * Patients with major cognitive disorders (MOCA\>23). * Patients with vestibular disorders. * Patient with uncontrolled epilepsy. * Patient with an unhealed amputation stump. * Patients weighing \> 135kg or \< 20kg. * Patients with a functional ambulation category of 1 (i.e. patients requiring the firm, continuous assistance of another person to carry their weight and maintain their balance) or less. * Patients with medication affecting exercise tolerance, * Patients with sensory impairments * Patients with significantly reduced bone density * Patients for whom it is impossible to correctly adjust the harness to the corresponding body part due to: * Body shape * Colostomy bags * Skin lesions that cannot be adequately protected. * Any other reason that prevents proper, pain-free adjustment of the sling. * Pregnant, parturient or breast-feeding patients. * Appearance of a stump wound during the study requiring discharge. * Patient with more than 50% absenteeism from rehabilitation sessions. * Patient requiring a new prosthesis insert. * Patient with a serious adverse event affecting dynamic balance rehabilitation.
Contact & Investigator
Eric Pantera
PRINCIPAL INVESTIGATOR
CHU de Nimes
Frequently Asked Questions
Who can join the NCT06424249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Amputees / Rehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06424249 currently recruiting?
Yes, NCT06424249 is actively recruiting participants. Contact the research team at eric.pantera@chu-nimes.fr for enrollment information.
Where is the NCT06424249 trial being conducted?
This trial is being conducted at Le Grau-du-Roi, France, Nîmes, France.
Who is sponsoring the NCT06424249 clinical trial?
NCT06424249 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Eric Pantera at CHU de Nimes. The trial plans to enroll 20 participants.