Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how virtual reality (VR) can help improve balance in people who have undergone a unilateral transtibial amputation, which means they have lost a leg below the knee. The researchers believe that using VR during rehabilitation may provide better outcomes for balance compared to traditional rehabilitation methods. By focusing on dynamic balance, which is how well a person can control their movements while standing or walking, the trial aims to help participants regain their independence and improve their ability to use a prosthesis effectively.

Eligible participants are adults aged 18 to 75 who have had a leg amputated below the knee for various reasons, such as injury or health issues. They should be able to walk on a treadmill for five minutes without assistance and will need to give their consent to participate. Throughout the trial, participants will engage in rehabilitation sessions that incorporate VR, allowing them to experience personalized treatment and track their progress. It’s important to note that some individuals may not qualify if they have certain health issues or if their amputation is not healing properly.

Gender

ALL

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.