Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation (EQUIL-ARC)

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.

Study Overview

• Status: Recruiting
• Conditions: Virtual Reality; Postural Balance; Amputees / Rehabilitation
• Intervention / Treatment: Other: Virtual Reality; Other: Standard rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Pantera; Phone Number: 04 66 02 25 36; Email: eric.pantera@chu-nimes.fr

Study Locations

• France
  • Le Grau-du-Roi, France, 30240
    • Recruiting
    • CHU de Nîmes, Hôpital du Grau du Roi
    • Contact: Eric PANTERA, MD
  • Nîmes, France
    • Not yet recruiting
    • CHU de Nimes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Eric PANTERA
    • Sub-Investigator: Nicolas RENEAUD
    • Sub-Investigator: Antoine Brisset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	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.
Experimental: Virtual Reality group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length variability between groups	Meters, measured with the GRAIL rehabilitation and movement analysis platform	Before rehabilitation (Day 1)
Step length variability between groups	Meters, measured with the GRAIL rehabilitation and movement analysis platform	End of rehabilitation sessions (Day 45)
Step width variability between groups	Meters, measured with the GRAIL rehabilitation and movement analysis platform	Before rehabilitation (Day 1)
Step width variability between groups	Meters, measured with the GRAIL rehabilitation and movement analysis platform	End of rehabilitation sessions (Day 45)
Cadence variability between groups	Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform	Before rehabilitation (Day 1)
Cadence variability between groups	Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform	End of rehabilitation sessions (Day 45)
Center of mass variability between groups	Meters, measured with the GRAIL rehabilitation and movement analysis platform	Before rehabilitation (Day 1)
Center of mass variability between groups	Meters, measured with the GRAIL rehabilitation and movement analysis platform	End of rehabilitation sessions (Day 45)
Mobility and balance between groups	Time Up and Go test, seconds	Before rehabilitation (Day 1)
Mobility and balance between groups	Time Up and Go test, seconds	End of rehabilitation sessions (Day 45)
Aerobic endurance and functional capacity between groups	2-minute walk test, meters	Before rehabilitation (Day 1)
Aerobic endurance and functional capacity between groups	2-minute walk test, meters	End of rehabilitation sessions (Day 45)
Fall risk between groups	Berg scale, score between 0 and 56 (no fall risk)	Before rehabilitation (Day 1)
Fall risk between groups	Berg scale, score between 0 and 56 (no fall risk)	End of rehabilitation sessions (Day 45)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Eric Pantera, CHU de Nimes

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Local/2023/EP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No