Improving balance in amputees using virtual reality versus traditional rehab
Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
This study tests whether using virtual reality for rehab can help people with one leg amputated below the knee improve their balance better than traditional rehab methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 2 sites (Le Grau-du-Roi and 1 other locations) |
| Trial ID | NCT06424249 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a virtual reality rehabilitation program compared to conventional rehabilitation methods for unilateral transtibial amputees. The focus is on enhancing dynamic balance, which is crucial for improving gait patterns and overall autonomy in amputees. Participants will undergo personalized treatment that includes movement analysis to objectively assess their progress. The hypothesis is that virtual reality will yield better outcomes in balance assessment compared to standard rehabilitation techniques.
Who should consider this trial
Good fit: Ideal candidates are unilateral transtibial amputees who are hospitalized and able to walk for at least 5 minutes on a treadmill without assistance.
Not a fit: Patients with major cognitive disorders or uncorrected visual impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance balance and mobility in amputees, leading to improved quality of life.
How similar studies have performed: While the use of virtual reality in rehabilitation is gaining traction, this specific approach for unilateral transtibial amputees is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Le Grau-du-Roi and 1 other locations
- CHU de Nîmes, Hôpital du Grau du Roi — Le Grau-du-Roi, France (Recruiting)
- CHU de Nimes — Nîmes, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Eric Pantera — CHU de Nimes
- Study coordinator: Eric Pantera
- Email: eric.pantera@chu-nimes.fr
- Phone: 04 66 02 25 36
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.