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

Overview

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.

Interventions

• Other Virtual Reality
  A progressive rehabilitation protocol (different levels according to success scores) consisting of several exercises using virtual and augmented reality with mechanical perturbations (pitching of the treadmill), interaction with the virtual environment, interaction with the virtual environment and augmented reality (projection of obstacles on the treadmill), and modification of the gait pattern with visual and/or audio biofeedback
• Other Standard rehabilitation
  A treadmill walking protocol with virtual reality to immerse the patient in a 3 x 5-minute walking session, without visual, mechanical or auditory disturbances, and without prompting the patient to modify their walking pattern.

Primary outcome measures

• Mediolateral instability during mediolateral external perturbation between groups [Time frame: Before rehabilitation (Day 1)]
• Mediolateral instability during mediolateral external perturbation between groups [Time frame: End of rehabilitation sessions (Day 45)]

Secondary outcome measures (12)

• Step length variability between groups [Time frame: Before rehabilitation (Day 1)]
• Step length variability between groups [Time frame: End of rehabilitation sessions (Day 45)]
• Step width variability between groups [Time frame: Before rehabilitation (Day 1)]
• Step width variability between groups [Time frame: End of rehabilitation sessions (Day 45)]
• Cadence variability between groups [Time frame: Before rehabilitation (Day 1)]
• Cadence variability between groups [Time frame: End of rehabilitation sessions (Day 45)]
• Center of mass variability between groups [Time frame: Before rehabilitation (Day 1)]
• Center of mass variability between groups [Time frame: End of rehabilitation sessions (Day 45)]
• Mobility and balance between groups [Time frame: Before rehabilitation (Day 1)]
• Mobility and balance between groups [Time frame: End of rehabilitation sessions (Day 45)]
• Aerobic endurance and functional capacity between groups [Time frame: Before rehabilitation (Day 1)]
• Aerobic endurance and functional capacity between groups [Time frame: End of rehabilitation sessions (Day 45)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 2 centers

• CHU de Nîmes, Hôpital du Grau du Roi — Le Grau-du-Roi
• CHU de Nimes — Nîmes

Identifiers

NCT: NCT06424249 · Local/2023/EP-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗