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

NCT06424249 | Recruiting

• 1 other identifier: Local/2023/EP-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Amputees / Rehabilitation; Virtual Reality; Postural Balance

Outcome Measures

Primary Outcomes (2)

• Mediolateral instability during mediolateral external perturbation between groups

  The number of gait cycles required to regain center of mass displacement (number of cycles \* cycle time), measured with the GRAIL rehabilitation and movement analysis platform

  Before rehabilitation (Day 1)

• Mediolateral instability during mediolateral external perturbation between groups

  The number of gait cycles required to regain center of mass displacement (number of cycles \* cycle time), measured with the GRAIL rehabilitation and movement analysis platform

  End of rehabilitation sessions (Day 45)

Secondary Outcomes (14)

• Step length variability between groups

  Before rehabilitation (Day 1)

• Step length variability between groups

  End of rehabilitation sessions (Day 45)

• Step width variability between groups

  Before rehabilitation (Day 1)

• Step width variability between groups

  End of rehabilitation sessions (Day 45)

• Cadence variability between groups

  Before rehabilitation (Day 1)

Study Arms (2)

Virtual Reality group

EXPERIMENTAL

Other: Virtual Reality

Control group

ACTIVE COMPARATOR

Other: Standard rehabilitation

Interventions

Virtual Reality OTHER

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

Virtual Reality group

Standard rehabilitation OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Nîmes, Hôpital du Grau du Roi

Le Grau-du-Roi, 30240, France

RECRUITING

CHU de Nimes

Nîmes, France

NOT YET RECRUITING

Study Officials

• Eric Pantera

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Pantera

CONTACT

04 66 02 25 36; eric.pantera@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)