Improving balance in amputees using virtual reality versus traditional rehab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.