Clinical trial NCT06424249: Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
Official title: Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputees / Rehabilitation
Virtual Reality
Postural Balance
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: Mediolateral instability during mediolateral external perturbation between groups
timeFrame: Before rehabilitation (Day 1)
measure: Mediolateral instability during mediolateral external perturbation between groups
timeFrame: End of rehabilitation sessions (Day 45)
Secondary outcomes:
measure: Step length variability between groups
timeFrame: Before rehabilitation (Day 1)
measure: Step length variability between groups
timeFrame: End of rehabilitation sessions (Day 45)
measure: Step width variability between groups
timeFrame: Before rehabilitation (Day 1)
measure: Step width variability between groups
timeFrame: End of rehabilitation sessions (Day 45)
measure: Cadence variability between groups
timeFrame: Before rehabilitation (Day 1)
measure: Cadence variability between groups
timeFrame: End of rehabilitation sessions (Day 45)
measure: Center of mass variability between groups
timeFrame: Before rehabilitation (Day 1)
measure: Center of mass variability between groups
timeFrame: End of rehabilitation sessions (Day 45)
measure: Mobility and balance between groups
timeFrame: Before rehabilitation (Day 1)
measure: Mobility and balance between groups
timeFrame: End of rehabilitation sessions (Day 45)
measure: Aerobic endurance and functional capacity between groups
timeFrame: Before rehabilitation (Day 1)
measure: Aerobic endurance and functional capacity between groups
timeFrame: End of rehabilitation sessions (Day 45)
measure: Fall risk between groups
timeFrame: Before rehabilitation (Day 1)
measure: Fall risk between groups
timeFrame: End of rehabilitation sessions (Day 45)
Other outcomes:
Locations:
city: Le Grau-du-Roi
country: France
facility: CHU de Nîmes, Hôpital du Grau du Roi
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU de Nimes
name: Eric Pantera
role: PRINCIPAL_INVESTIGATOR
References: