Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
NCT ID: NCT06424249
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-10-14
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Virtual Reality group
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
Control group
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Eric Pantera
Role: PRINCIPAL_INVESTIGATOR
CHU de Nimes
Locations
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CHU de Nîmes, Hôpital du Grau du Roi
Le Grau-du-Roi, , France
CHU de Nimes
Nîmes, , France
Countries
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Central Contacts
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Facility Contacts
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Eric PANTERA, MD
Role: primary
Other Identifiers
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Local/2023/EP-02
Identifier Type: -
Identifier Source: org_study_id
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